Coca Leaf - a Safe Food Additive

1.0.1    Claim of Eligibility under 21 CFR 170.30(c)(2)

Decoctions of Erythoxylum coca, meeting the specifications for KukaXoco's "KukaXoco" line of unsweetened cocoa products, as described below, have been determined to be Generally Recognized As Safe (GRAS) in accordance with 21 U.S. Code, Chapter 9, the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et al.), and 21 CFR 170.30(c)(2): "A substance used in food prior to January 1, 1958, may be generally recognized as safe through experience based on its common use in food when that use occurred exclusively or primarily outside of the United States if the information about the experience establishes that the use of the substance is safe within the meaning of the Act. (see 21 CFR 170.3(i)). Common use in food prior to January 1, 1958, that occurred outside of the United States shall be documented by published or other information and shall be corroborated by information from a second, independent source that confirms the history and circumstances of use of the substance." This determination is based on widely-available, published scientific research inside and outside the United States that confirms the history and circumstances of the consumption of decoctions of Erythoxylum coca, as described in the following sections. The evaluation reflects the intended uses of the decoctions in food products based on unsweetened cocoa.

Signed:

1.0.2    Name and Address of Notifiers

For questions pertaining to issues of decoctions of Erythoxylum coca in the United States, please contact:

KukaXoco LLC
P.O. Box 94
Belmont, MA 02478

As the representative of the Notifiers, KukaXoco LLC accepts responsibility of the GRAS determination that has been made for decoctions of Erythoxylum coca. For questions pertaining to issues of teas based on the coca leaf (Erythoxylum coca), please contact the following institutions:

[............]
[............]
[............]

We are seeking that the governments of Bolivia, Perú and Colombia agree to be Notifiers of this GRAS determination for decoctions of Erythroxylum coca.

1.0.3    Name and Address of Co-Notifiers

Information on decoctions of Erythoxylum coca with regards to "its common use in food when that use occurred exclusively or primarily outside of the United States" was provided, in part, thanks to the assistance of the following co-Notifiers:

Instituto InterAndino de Ciencias de la Coca
Avenida Villazón N^o 1978, Local 6
La Paz, Bolivia (591-2 223 2837)
www.cienciadelacoca.org

We are seeking civic groups and organizations of producers/growers of coca leaf from Bolivia, Perú and Colombia to agree to be co-Notifiers of this GRAS determination for decoctions of Erythroxylum coca.

1.0.4    Common Name & Identity of Notified Substance

Under current federal regulations, 21 C.F.R. 182.20, titled "Substances Generally Recognized as Safe (GRAS) - Essential Oils, Oleoresins and Natural Extractives", extracts of coca leaves (that have been decocainized), are explicitly determined to be GRAS. One type of such extracts are decoctions of coca leaves, minus the coca alkaloids that are removed during the process of decocainization. In light of a 1996 NIH analysis of decoctions of Erythoxylum coca (see Appendix A, "Identification and quantitation of alkaloids in coca tea", Forensic Sci Int., 1996 February 9; 77(3): 179-189), GRAS determination is sought for four Notified Substances in decoctions of Erythoxylum coca: methylbenzoylecgonine (CAR number 50-36-2) (PubChem CID 446220), benzoylecgonine (CAR number 519-09-5) (PubChem CID 448223), ecgonine methyl ester (PubChem CID 104904), and trans-cinnamoylcocaine. (PubChem CID 6440936),

1.0.5    Conditions of Intended Use in Food

Decoctions of Erythoxylum coca are intended to be added as a supplement into a limited number of conventional food products, many based on unsweetened cocoa, as described in this document.

1.0.6    Basis for the GRAS Determination

Pursuant to 21 C.F.R. 170.30, decoctions of Erythoxylum coca have been determined to be GRAS on the basis of scientific procedures as discussed in the detailed description provided below.

1.0.7    Availability of Information

The data and information that serve as the basis for this GRAS Notification will be sent to the U.S. Food and Drug Administration (FDA) upon their request, or is available for review and copying at the offices of KukaXoco LLC. Much of this information is publicly available on the Internet, at the Web site: www.cienciadelacoca.org, in particular, one section of the Web site: www.cienciadelacoca.org/GRAS.html.

2.0    INTRODUCTION

2.0.1    Objective

For its own food products, and on behalf of its co-notifiers and their interests in related food products, KukaXoco LLC has undertaken an independent safety evaluation of decoctions of Erythoxylum coca, for use in foods. The purpose of the evaluation is to ascertain whether or not the intended food use of the decoctions can be considered to be generally recognized as safe (GRAS) when used as a supplement in selected food products.

2.0.2    Foreword

KukaXoco LLC has compiled information on intended use, specifications for the manufacture of products using decoctions of Erythoxylum coca, and published toxicology studies for alkaloids found in the decoctions. Determining how much of these alkaloids can be safely consumed, i.e., the so-called "dose" or use levels, is critical in determination of safe exposure levels of these alkaloids when consumed as a food ingredient. The composite safety/toxicity studies in concert with exposure information constitute the two critical information components that form the basis of the GRAS evaluation.

The safety/toxicity analysis, consumption/exposure information, and other related documentation were augmented with an independent search of the scientific and regulatory literature, which included (21 C.F.R. 182.20). Based upon the composite information, a GRAS assessment based primarily on available safety information and common occurrence in food was undertaken. Those references that were deemed pertinent to the objective at hand are listed in Section 8.

Establishing that decoctions of Erythoxylum coca are GRAS, especially for food products that may have medicinal benefits, is consistent with the desires of 2006 World Health Organization (WHO) brief report, "Contribution of traditional medicine to public health: coca leaf". In the report, a WHO executive board states that there is still need to show that there are no negative health effects in consuming products made from coca leaf, and that such products meet national regulatory requirements for safety, efficacy and quality. The WHO brief report is available at: http://apps.who.int/gb/ebwha/pdf_files/EB120/b120_36-en.pdf.

2.0.3    FDA Regulatory Framework

Ingredients for use in foods must undergo pre-market approval by the FDA as food additives or, alternatively, the ingredients to be incorporated into foods must be determined to be generally recognized as safe (GRAS). The authority to make GRAS determinations is not restricted to the FDA. In fact, GRAS determinations may be provided by experts who are qualified by scientific training and experience to evaluate the safety of food and food ingredients under the intended conditions of use.

In 1997, the FDA altered the GRAS determination process by eliminating the formal GRAS petitioning process, and replacing the petitioning process with a notification procedure. While outlining the necessary content to be considered in making a GRAS determination, the FDA encouraged that such determinations be provided to the FDA in the form of a notification.

2.0.4    Regulatory History of Decoctions of Erythroxylum coca, and Cacao

Under current federal regulations, 21 C.F.R. 182.20, titled "Substances Generally Recognized as Safe (GRAS) - Essential Oils, Oleoresins and Natural Extractives", both extracts of cacao (which include unsweetened cocoa), and extracts of coca leaves (that have been decocainized), are explicitly determined to be GRAS.

3.0    INGREDIENT IDENTITY, CHEMICAL CHARACTERIZATION, MANUFACTURING PROCESS & PURITY

3.0.1    Common Name & Identity of the Notified Substance

In light of a 1996 NIH analysis of decoctions of Erythoxylum coca (see Appendix A, "Identification and quantitation of alkaloids in coca tea", Forensic Sci Int., 1996 February 9; 77(3): 179-189), GRAS determination is sought for four Notified Substances in decoctions of Erythoxylum coca: methylbenzoylecgonine (CAR number 50-36-2) (PubChem CID 446220), benzoylecgonine (CAR number 519-09-5) (PubChem CID 448223), ecgonine methyl ester (PubChem CID 104904), and trans-cinnamoylcocaine. (PubChem CID 6440936). The three minor alkaloids found in decoctions of Erythoxylum coca (benzoylecgonine, ecgonine methyl ester and trans-cinnamoylcocaine) do not have any euphoric or stimulating effect on the human body, and generally have LD50 values greater than that of methylbenzoylecgonine. See: "Biological activity of the alkaloids of Erythoxylum coca and Erythoxylum novogranatense", M. Novak et al., Journal of Ethnopharmacology, v10 (1984), 261-274; Pubmed abstract available at: http://www.ncbi.nlm.nih.gov/pubmed/6379304).

3.0.2    Principal Chemical Components of the Notified Substance

METHYLBENZOYLECGONINE
Methylbenzoylecgonine - C₁₇H₂₁NO₄ - is a natural tropane alkaloid. Also referred to as benzoylmethylecgonine, ecgonine methyl ester benzoate, (1R,2R,3S,5S)-(-)-cocaine and 2b-carbomethoxy−3b-benzoyloxy tropane. As discussed below, methylbenzoylecgonine is also very confusingly referred to as cocaine, the confusion being that it very chemically different from its pharmaceutical salt, methylbenzoylecgonine hydrochloride, the drug typically meant by cocaine in most medical and political contexts. Additionally, (1R,2R,3S,5S)-(-)-cocaine is the only stereoisomer of this molecule that is addictive (see: "Synthesis and ligand binding of cocaine isomers at the cocaine receptor", F. Ivy Carroll et al., J. Med. Chem., v 34 (1991), pg. 883-886). Non-addictive analogs of methylbenzoylecgonine are available (see U.S. Patent 8,557,842). These chemical analogs are not Notified Substances in this GRAS filing.

BENZOYLECGONINE
Benzoylecgonine - C₁₆H₁₉NO₄ - is a tropane alkaloid, and is the primary metabolite of methylbenzoylecgonine. This Notified Substance is one of the three main minor alkaloids found in decoctions of Erythroxylum coca that do not have any euphoric of stimulating effect on the human body, and generally have LD50 values superior to that of methylbenzoylecgonine.



ECGONINE METHYL ESTER
Ecgonine Methyl Ester - C₁₀H₁₇NO₃ - is also referred to as methyl ecgonine, and is also a metabolite of methylbenzoylecgonine. This Notified Substance is one of the three main minor alkaloids found in decoctions of Erythroxylum coca that do not have any euphoric of stimulating effect on the human body, and generally have LD50 values superior to that of methylbenzoylecgonine.



trans-CINNAMOYLCOCAINE
trans-Cinnamoylcocaine - C₁₉H₂₃NO₃ - is a natural tropane alkaloid, also referred to as methylecgonine cinnamate, cinnamylcocaine, and methylcinamylecgonine. This Notified Substance is one of the three main minor alkaloids found in decoctions of Erythroxylum coca that do not have any euphoric of stimulating effect on the human body, and generally have LD50 values superior to that of methylbenzoylecgonine.

3.0.3    Chemical Properties of Principal Chemical Components of the Notified Substance

Decoctions of coca tea have as a predominant chemical, the main coca alkaloid, methylbenzoylecgonine, which has the following chemical properties:

Property	Value
Molecular Formula	C17H21NO4
Molecular Weight	303.353 g/mol
Color	Colorless to white crystals/powder
Melting Point	98 °C
Boiling Point	187 °C
Vapor Pressure	1.91 * 10-7 mm Hg at 25 °C
LD50	3450 mg/kg
Solubility	Slightly soluble in water, glycerol, fat;     very soluble in ethanol

Coca leaves themselves are known to contain a wide variety of vitamins, minerals, protein, fiber and other nutritional elements. We refer to the often-cited study, "Nutritional Value of Coca", by James Duke et al;, Botanical Museum Leaflets, Harvard University, v 24 n 6, 1975, 113-119 (see Appendix F), which provided the following data:

Component	Amount in 100 grams of coca
Calories	305.0
Water	8.5 g
Protein	18.8 g
Fat	13.3 g
Carbohydrates	44.3 g
Fiber	13.3 g
Calcium	1,790 mg
Coca Alkaloids	0.5-1.5%
Phosphorus	637.0 mg
Iron	26.9 mg
Vitamin A	10,999
Thiamine B1	0.58 mg
Riboflavin B2	1.33 mg
Niacin	3.73 mg
Vitamin C	1.40 mg
Vitamin E	43.5 UI
Vitamin B5	0.308 mg
Vitamin B12	1.05 mg
Folic Acid	0.1 mg
Biotin	0.0 mg
Pantothenic Acid	0.68 mg
Iodine	5.0 mg
Magnesium	213.0 mg
Copper	1.21 mg
Sodium	40.6 mg

3.0.4    Manufacturing Process

Only organically grown leaves are used in the manufacturing of decoctions of Erythroxylum coca. There are farms in Bolivia that grow organic coca, and one company in La Paz, Bolivia, CocaCoquita SRL, works with such farms, both in bringing their product to market, as well as helping them improve their farming techniques to avoid use of chemical pesticides. A additional step of labor removes the stems from the leaves.

The manufacture of decoctions of Erythroxylum coca is typically a two-step process. In the first step, the coca leaves are decocted. Either whole leaves are used, or ground up leaves. The leaves are then brewed with in hot water for a short amount of time (minutes), or are left to sit in cold water for many hours, or have water slowly dripped through the leaves ("cold-drip brewing") also for many hours. No other chemicals or ingredients are added - just the leaves and water. The water is typically filtered water that is purchased commercially, or natural spring water that has been filtered.

In the second step, the decoction is dehydrated, partially to prepare a liquid decoction, and totally to prepare a powdered form of the decoction (which lends itself to mixing and being shipped with powdered cocoa). The dehydration is achieved via distallation using glass equipment.

No use is made of alcohols, acids or petroleum products, to prepare the decoction.

3.0.5    Product Purity

As the manufacturing process only uses organic coca leaf and filtered water, there are few sources of contamination products for manufacturing facilities that meet government sanitation standards.

Alcohol Rinse. To improve taste and safety, the coca leaves (e.g., full or milled) can first be washed in an alcohol such as ethanol (e.g., quickly rinsing 15 grams of coca tea leaves with 350 milliliters of a solution that is 96% ethanol and 4% water). After the rinse, the wet leaves are dried, which removes all of the alcohol. This rinse process removes surface contaminants, if any, as well part of the chemicals in leaves (e.g., chlorophyll), the tastes of which can interfere with the chocolate taste of the products disclosed herein. A multi-hour, slow-drip brewing of coca leaves or tea, with this ethanol solution, extracts a substantial amount of coca alkaloids.

[To be prepared]. Attached is a table of non-alkaloid trace elements found in a typical sample of a decoction.

3.0.6    Minor Chemical Components of the Notified Substance

Decoctions of Erythroxylum coca will have minuscule amounts of the lesser alkaloids of the coca plant, present at levels less than 0.1% (weight/weight) relative to methylbenzoylecgonine. There have never been any reports of any physiological effects of these lesser alkaloids when consumed in the form of coca teas. Two articles report on these lesser alkaloids: Lesser alkaloids of cocaine-bearing plants: II. 3-oxo-substituted tropane esters, John Casale and James Moore (U.S. DEA), in Journal of Chromatography A, v 749 (1996), 173-180; and Lesser alkaloids of cocaine-bearing plants: III. 2-carbomethoxy-3-oxo substituted tropane esters, John Casale and James Moore (U.S. DEA), in Journal of Chromatography A, v 756 (1996), 185-192. Both papers are available upon request.

3.0.7    GRAS Components of the Notified Substance

All other components of decoctions of Erythroxylum coca are GRAS under current federal regulations, 21 C.F.R. 182.20, titled "Substances Generally Recognized as Safe (GRAS) - Essential Oils, Oleoresins and Natural Extractives", which includes decoctions of Erythroxylum coca that have had the methylbenzoylecgonine removed.

Some consumer beverages, such as Coca Cola, use decocainized coca leaves that are GRAS. One study (unpublished) reported that such beverages, which have been highly consumed for over 100 years, contain trace amounts of coca alkaloids, typically 1/1000th the concentration of decoctions of Erythroxylum coca. Such low levels of coca alkaloids in foods products is thus assumed to be GRAS. This unpublished paper is: "Toxicological analysis of Coca Cola from Bolivia, Chile, USA and Peru", T. Llosa and E. Comenares, Clínica de Adicciones Químicas, v 5, n 1, COCADI, Lima (1994).

4.0    INTENDED USE & DIETARY EXPOSURE

4.0.1    Coca Leaf Tea (Erythroxylum coca)

Coca Leaf

It is important to understand that coca leaves and cocaine hydrochloride are different things. Cocaine hydrochloride is not a component of coca tea, and is obtained through the chemical processing of coca leaves in conjunction with other chemicals (some that are toxic).

Unlike any gaseous or refreshing drink, coca tea, due to its properties, effectively supports all the vital activities of its consumer.

Coca tea possesses anti-oxidant properties and contains nutrients, beneficial oils that make it a natural and curative drink.

Coca tea contains no preservatives or colorings, is 100% natural, and has a pleasant aroma. Its delicious flavor is the result of careful selection and processing which keeps intact all its healthy qualities.

A medical book published by the World Health Organization in 1985 said that: when "talking about the coca leaf, it is necessary to emphasize that it is a medicinal plant of great benefit, that has analgesic, soothing, astringent, and anti-flatulent properties, and that it is an agent for blood cleaning, digestion, diuresis and respiratory stimulation."

Coca tea does not have psycho-stimulant or intoxicating effects. Therefore it is recommended for daily use as a preventive and curative product. You can drink it in the morning, afternoon, and evening.

In their research, Collazos, Urquieta and coca Alvistur conducted studies of the coca leaves from Convention (Cusco), Granary (Cusco), Huamalíes (Huanuco) and Celendin (Cajamarca), determining the average moisture, nitrogen, fiber, ash, calcium (amounts the highest among the plants in the Andean region), phosphorus, iron, carotene, vitamin B1 (thiamine), vitamin B2 (riboflavin), niacin and cocaine, concluding that in 23 samples of coca leaf that were were tested, significant amounts of calcium, carotene, riboflavin, thiamine, niacin and iron were measured. The results were suggestive of good absorption and transformation of carotene to vitamin A. In this study, 6 volunteers (5 using lime and one without), chewed coca leaves in amounts ranging between 35 and 50 grams of leaves in four hours. The volunteers absorbed between 60 and 160 milligrams of cocaine. Pulse, breathing rate, and blood pressure, as well as the baseline behavior at the initiation of the study, did not change significantly.

This study was conducted with Peruvian coca, unlike they study of Duke, Aulik and Plowman (at Harvard University) with Bolivian coca, but both agree on the analysis of the nutrient content of both plants, with critiques and scholars of the nutritional value of coca generally only mentioning the study of the Americans. Both studies are very clear in emphasizing the high content of nutrients of coca leaves.

Coca tea contains vitamins A, E, B1, B2, B3 and C (ascorbic acid), proteins, macro - and micro elements (calcium, phosphorous, iron, sodium and potassium), tannin and also a total of fourteen alkaloids that are responsible for their beneficial curative action. It is common knowledge that the use of coca leaves helps balance the biological instability that produces fatigue and stress.

Characteristcs of Coca Leaf Tea

Physical characteristics: Coca tea is a natural product made from coca leaves (100% selected), maintaining all of the physical and chemical properties of the raw material.

Organic characteristics (infusion):

• Color: yellow to green
• Odor: pleasant
• Taste: pleasant

A special use of coca leaves as a tea (mate de coca) was implemented more than 15 years ago by Dr. Theobald Llosa Rojas in Peru, and Dr. Jorge Hurtado Gumucio in Bolivia (both researchers, doctors and psychiatrists), as a replacement therapy to control addiction to inhaled and smoked (coca paste, crack) cocaine, with notable successes at a low cost.

Governments of Bolivia, Peru and Colombia are discussing the best way to open the markets of countries of South and North America, Europe, Asia and Africa, for coca leaf tea, ensuring, from its history, the fact that coca leaf tea is a completely safe product for consumers. In countries where coca leaf is grown and/or legally sold, there have been no reports of illness or disease by excessive consumption of coca tea. In these countries, coca leaf teas are safe enough to be sold in supermarkets.

Therefore, these governments accept the responsibility of being GRAS Notifiers for this application (which will be submitted to the FDA) regarding coca leaf tea using whole leaf coke. They accepted a similar responsibility for the application of food safety that will be submitted to the EFSA (European Food Safety Agency), and to the agencies that regulate food safety in other countries.

For questions about the manufacture or safety of coca leaf in Bolivia, please contact: the Vice Ministry of Coca and Integral Development (VCDI -), in particular the Directorate General of Coca and Industrialization (DIGCOIN -). In Bolivia, SENASAG (National Agricultural and Food Safety Security), which for many years has approved the sale and consumption of a variety of coca tea products.

4.0.2    Decoction of Erythroxylum coca and Unsweetened Cocoa

Research has shown that decoctions of Erythroxylum coca can completely debitter cocoa powder that is free of sugar, sweeteners and fat, while retaining much of the taste, smell and color of chocolate. This breakthrough allows large amounts of cocoa to be consumed for its many medical benefits, without having to consume any unhealthy amounts of sugar. This breakthrough will significantly increase the size of the chocolate market, which is currently valued at over $100 billion per year.

This debittering effect can be easily experienced in a very simple experiment. Brew two to four bags of coca tea in hot water. Mix in two tablespoons of unsweetened cocoa power, such as Hershey's Unsweetened Cocoa. The resulting beverage is not bitter, and can be drunken as easily, if not more so, than a cup of black coffee or tea. The resulting beverage retains much of the taste, smell and color of chocolate, without any unhealthy added sugars.

First Intended Use: This discovery, and intended use of the Notified Substances, are discussed in much detail in a patent application available from the World Intellectual Property Organization (also attached as Appendix C). The application is titled: "Uses of coca leaf or Valerian root to reduce bitterness in foods containing unsweetened cacao", WIPO Publication Number WO/2015/013679. The entire set of filings for this application are available at: https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2015013679.

A general formula for intended uses of the Notified Substances with unsweetened cocoa can be seen in the following claim-like language:

       A cocoa-based foodstuff having reduced bitterness to taste, comprising:

       C grams of unsweetened cocoa;

       AL grams of at least one coca alkaloid;

       F grams of fat and/or S grams of sweeteners;

       wherein 0 ≲ (F + S) ≲ C and

       wherein the ratio AL/(C + F + S) ≲ 0.001

Note: this terminal condition, that the amount of coca alkaloid needed is one-tenth of one-percent by weight of the food product (for example, ten milligrams of coca alkaloid for every 10 grams of food product) has two benefits. First, it means that only very low amounts of decoctions of Erythroxylum coca are needed, minimizing any potential health safety risks.

Second, for such food products that provide health benefits, these low amounts satisfy the levels of use of cocaine-related ingredients in medical products as stipulated by the Single Convention on Narcotic Drugs - 1961 (SCOND), an international treaty maintained by the United Nations. Footnote 4 of Schedule III states: "4. Preparations of Cocaine containing not more than 0.1 per cent of cocaine calculated as cocaine base ....... compounded with one or more other ingredients and in such a way that the drug cannot be recovered by readily applicable means or in a yield which would constitute a risk to public health."

Decoctions of Erythroxylum coca easily satisfy this restriction, and more so, since decoctions of Erythroxylum coca have effects many orders weaker than the cocaine use contemplated in Schedule III. See: "Single Convention on Narcotic Drugs", www.unodc.org/pdf/convention_1961_en.pdf.

Second Intended Use: A second intended use of the Notified Substances is for the design of a tactical nutritional supplement for soldiers of the U.S. military. Currently, the U.S. military is engaged in some operations in environments that are at high altitudes and low temperatures – for example, some of the mountain regions of Afghanistan and Pakistan. These environments are similar to those of the high plains (Altiplano) of the Andes, where for centuries, the people have used decoctions of Erythroxylum coca, and coca chewing, for obtaining at least two physiological benefits: suppressing hunger until the end of a long journey (similar to a military patrol) and reducing heat loss through vasoconstriction. A nutritional supplement along the lines of the First Intended Use, but with additional nutrients to sustain soldiers during their missions, is currently being designed, for submission for consideration to the U.S. military.

Medical Benefits of Unsweetened Cacao Enabled by Decoctions of Erythroxylum coca

While cocoa contains caffeine (along with many nutrients such as flavonols, and flavor compounds [see Schieb2000]), one important alkaloid it contains is a homologue of caffeine, theobromine (the free tertiary amine in theobromine is methylated in caffeine). Generally, cocoa powder comprises between about 2% to about 10% of theobromine.

In recent years, various studies have shown that consumption of cocoa can result in decreases in the rates of heart disease, cancer, diabetes and other health problems (see Franco2013). A study published in Caries Research in 2015 reported that theobromine is as effective as fluorine in the remineralization of teeth and in fighting tooth decay (see Amae2013). Another study published in Molecular Nutrition & Food Research in 2015 reported that cocoa intake, at least in rats, may delay progression of type 2 diabetes (see Fernan2015). Another study published in 2008 reported that drinking two cups of hot chocolate a day may help older people increase blood flow in the brain (see Sorond2008), with a 2014 study showing that a high cocoa diet improves cognition in older adults (see Brick2014). Another study published in 2010 reported that theobromine-enriched cocoa lowered central systolic blood pressure (see Bogard2010). Levels of theobromine higher than natural in chocolate are known to act as a diet suppressant. Another study published in 2007 reported that regular consumption of dark chocolate that is rich in flavonols can lower arterial stiffness (see Vlach2007), while U.S. Patent 6,900,241 claims use of cocoa to treat atherosclerosis. Another study published in 2013 reported that theobromine seems to be the chemical in cocoa whose consumption leads to increases in serum-HDL (the so-called "good" cholesterol) concentrations (see Neufin2013). Mars, the chocolate company, has patented the use of some cocoa extracts as anti-tumor agents (see U.S. patent 7,820,713). Similarly, another chocolate company, Barry Callebaut, has patented the use of some cocoa extracts for treating prostate cancer (see U.S. patent 8,435,576). Also, recent studies have raised the question of whether people have too much added iron in their diets, and if this added iron is contributing to a variety of health problems such as heart disease and increased inflammation. Cocoa is known to decrease iron absorption while eating. In 2007, scientists in Panama studied the country's Kuna Indians, who consume large amounts of cocoa, typically consuming, each day, approximately 900 milligrams of flavonols in cocoa, as well as much theobromine. The result of the study was that deaths due to heart disease and cancer dropped by a factor of ten, and deaths due to diabetes dropped by a factor of four (see Bayard2007). While these effects cannot be solely attributed to the cocoa diet, there is a positive health contribution from this consumption of cocoa.

Only the presence of too much sugar and fat in chocolate deprives the world of the many health benefits available from the consumption of large amounts of chocolate. Only decoctions of Erythroxylum coca can make these health benefits available now, without any use of sugar or fats, while also contributing to the reduction of added sugars in the diet.

Brew two to four bags of coca tea in hot water



Stir in two tablespoons of unsweetened cocoa



Drink! Bitterness is all eliminated, retaining most of the color, smell and taste of chocolate - without sweeteners or fat.

4.0.3    Optional Use of N-acetylcysteine

For many intended uses of the Notified Substances in food products, consumers of such food products will be exposed to minor amounts of the main coca alkaloid, methylbenzoylecgonine. The amounts in any one serving of such food products will be similar to that of a few cups of coca tea -- five to ten milligrams of methylbenzoylecgonine. Little to none of the chemical is absorbed into the blood while in the oral cavity, and when swallowed, little of the chemical is absorbed into the blood while in the gastrointestinal tract (typically on the order of 1 milligram), since much of the chemical is broken down in the hot, wet, acidic environment of the stomach.

This use of decoctions of Erythroxylum coca does not lead to addiction (see Section 5.0 below), and any slight "cravings", if any, can be countered with addition of an over-the-counter nutritional supplement, n-acetylcysteine (also known as diacylglycerol). N-acetylcysteine, in multi-gram amounts, has been used to treat addictions to cocaine and tobacco, and in hundreds of milligrams to multi-gram amounts for other conditions (ibuprofen overdose, flu symptoms). Those amounts of n-acetylcysteine can be safely combined with the Notified Substances in their intended uses covered by this GRAS notification.

4.0.4    No Intended Use of Methylbenzoylecgonine Hydrochloride

The Notifier, and co-Notifiers, have absolutely no intention to use a related substance, a pharmaceutical salt, methylbenzoylecgonine hydrochloride, in any GRAS-related circumstances. The Notifier, and co-Notifiers, support all global efforts to prohibit any use of methylbenzoylecgonine hydrochloride in consumer products.

5.0    REVIEW OF SAFETY DATA ON DECOCTIONS OF Erythroxylum coca

All of these following medical reports prove that consumption of decoctions of Erythroxylym coca have a reasonable certainty of causing no harm.

5.0.1    Absorption, Distribution, Metabolism & Excretion of Decoctions of Erythroxylum coca

Decoctions of Erythroxylum coca are little absorbed by the human body, have some positive metabolic effects in terms of temporarily suppressing hunger, and are mostly broken down in the stomach and excreted in urine.

A 1991 study reported that for drinkers of decoctions of Erythroxylum coca, that 59% to 90% of the ingested methylbenzoylecgonine is excreted within 36 hours of ingestion, as measured by the presence of the metabolite benzoylecgonine in the urine. See: "Urinary excretion of benzoylecgonine following ingestion of Health Inca Tea", GF Jackson et al., Forensic Science International, v 49 n 1 (1991), pg. 57-64 (PubMed abstract at: http://www.ncbi.nlm.nih.gov/pubmed/2032667).

A 1981 NIH/NIDA study reported little accumulation in the blood of coca alkaloids that occurs while chewing coca leaves. Since chewing coca leaves results in more absorption of coca alkaloids than drinking decoctions of Erythroxylum coca, the following conclusions of their study applies even more so to decoctions of Erythroxylum coca: "While routes of administration for modern recreational use could lead to unexpected drug accumulation in the blood, it is not likely to occur from chewing coca leaves." and "... it is unlikely that coca chewing, as practiced for centuries in places like Macchu Picchu, presents the danger that may result from the modern forms of recreational use". See: "Cocaine pharmcokinetics in humans", Gene Barnett et al., Journal of Ethnopharmacology, v 3 (1981), pg 353-366 (CocaKinetics.pdf).

A 1996 study reported on the positive metabolic effects of coca chewing. Since chewing coca leaves results in more absorption of coca alkaloids than drinking decoctions of Erythroxylum coca, some of the following positive metabolic effects will hold true for drinking decoctions of Erythroxylum coca: "During prolonged (1 hour) submaximal exercise, chewers displayed a significantly greater adrenergic activation (as evidenced by a higher level of plasma epinephrine) and an increased use of fat (as evidence by a lower respiratory exchange ratio). The gradual increase in oxygen uptake ... could possibly be related to an enhanced glucose utilization by chewers during the late phase of exercise." See: "Effects of coca chewing on hormonal and metabolic responses during prolonged submaximal exercise", Roland Favier et al., J. Applied Physiology, vol 80 n2 (1996), pg. 650-655 (PubMed abstract at: http://www.ncbi.nlm.nih.gov/pubmed/8929611).

5.0.2    Biological Activity of Decoctions of Erythroxylum coca

Decoctions of Erythroxylum coca pose no dangerous biological activity. A 1986 article on the Journal of the American Medical Association reports that "Coca tea drinkers did not satisfy the diagnostic criteria for either cocaine intoxication or cocaine abuse, and their claims of 'controlled use' are supported by the weak preparations [of tea]" and "... for most of these [coca] tea drinkers [in the United States], like those in South America, the normal patterns of consumption do not result in ill effects or abuse". See: "Cocaine in Herbal Tea", by Dr. Ronald Siegel et al., J. American Medical Association, v 255 n1 (1986), pg.40 (JAMA abstract at: http://jama.jamanetwork.com/article.aspx?articleid=402364.

An earlier 1981 Harvard Medical School study reported on the safe use of coca as a folk medicine for thousands of years in Peru and Bolivia. See: "Coca and cocaine as medicines: an historical review", by Lester Grinspoon and James Bakalar, Journal of Ethnopharmacology, v 3 (1981), pg. 149-159 (PubMed abstract at: http://www.ncbi.nlm.nih.gov/pubmed/7017287).

More recently, a 2012 Wageningen University study reported on the effects of alkaloids of many sorts in the human food chain. Of relevance to this determination, they report that "For some alkaloids known to be present in the modern food chain, e.g., piperine, nicotine, theobromine, theophylline and tropane alkaloids, risks coming from the human food chain are considered to be low if not negligible." Theobromine is the main alkaloid of cocoa, and methylbenzoylecgonine (the main alkaloid of decoctions of Erythroxylum coca) is a tropane alkaloid. See: "Alkaloids in the human food chain -- natural occurrence and possible adverse effects", II Koleva et al., Molecular Nutrition and Food Research, v 56 n1 (2012), pg. 30-52 (PubMed abstract at: http://www.ncbi.nlm.nih.gov/pubmed/21823220).

5.0.3    Toxicology Studies on Decoctions of Erythroxylum coca

Decoctions of Erythroxylum coca pose no toxicological danger. A 1982 study at the University of Mississippi reported that the median lethal dose ("LD50") for decoctions of Erythroxylum coca is 3450 millgrams per kilogram (mg/kg). In comparison, common table salt is slightly more toxic, at 3000 mg/kg, along with menthol at 2900 mg/kg, and along with citric acid, a preservative added to foods (that also increases a sour taste) that has an LD50 of 3000 mg/kg. Caffeine is an order of magnitude more dangerous at 192 mg/kg, while nicotine (becoming a consumer beverage in liquid form due to the electronic cigarette business) is most toxic at 1 mg/kg.

Sodium nitrate, a food additive added to processed meats, and linked to colon cancer, has an LD50 of 180 mg/kg. Oxalic acid (found naturally in rhubarb) has an LD50 of 275 mg/kg. Aluminum sulphate, one of a family of controversial aluminum compounds added to food products such as baking soda, has an LD50 of 400 to 800 mg/kg.

One controversial food additive, for example in sports beverages, is brominated vegetable oil (BVO), which is being removed from products such as Gatorade for its toxicity. Surprisingly, there doesn't seem to be an LD50 measurement for such a controversial additive, and despite losing its GRAS status in 1970, it is still used in many soda drinks.

Disodium EDTA, a preservative, has an LD50 of 2000 to 3000 mg/kg, while another preservative, sodium benzoate has an LD50 of 1600 mg.kg. Thus, a commonly consumed beverage, Mountain Dew, has at least five ingredients more toxic and harmful to the body than decoctions of Erythroxylum coca: sugar, caffeine, sodium EDTA, sodium benzoate, and brominated vegetable oil.

Background information on the subject of a median lethal dose is available at: http://en.wikipedia.org/wiki/Median_lethal_dose. A copy of the 1982 paper, "Comparative lethality of coca and cocaine", John Bedford et al., Pharmacology Biochemistry & Behavior, vol. 18 (1982), pg. 1087-1088, which reported that decoctions of Erythroxylum coca are safer to consume than table salt, is available in Appendix D.

Additives highlighted in yellow are used (or are present) in chocolate.

5.0.4    Clinical Studies on Decoctions of Erythroxylum coca

One clinical study reported on the possibility of the chewing of coca leaf as a treatment for cocaine dependence (as opposed to being a "gateway" to cocaine use). Some excerpts: "Major ethnic groups in Bolivia (Aymaras and Quechuas) have chewed the coca leaf for generations upon generations without health problems. The effects of coca leaf chewing produce a level of social and economic adaptation that is beyond what is normally possible. This was a major factor during the Spanish colonization of Bolivia, when forced native labor was used extensively. ... Since 1984 I have recommended the chewing of the coca leaf, between 100 to 200 grams of coca leaf per week for the treatment of cocaine dependence. ... Upon final assessment, the level of social adaptation prior to treatment was only 28%, after treatment as many as 48.8% of the patients were socially adapted." See: "Coca leaf chewing as therapy for cocaine maintenance", J Hurtado-Gumucio, Ann Med Interne (Paris), v 151 (Oct 2000), Suppl B:B44-8 (PubMed abstract at: http://www.ncbi.nlm.nih.gov/pubmed/11104945).

5.0.5    Common Knowledge of Safe Consumption of Decoctions of Erythroxylum coca

Again is quoted: 21 CFR 170.30(c)(2): "A substance used in food prior to January 1, 1958, may be generally recognized as safe through experience based on its common use in food when that use occurred exclusively or primarily outside of the United States if the information about the experience establishes that the use of the substance is safe within the meaning of the Act." What follows is documentation of the common use of decoctions of Erythroxylum coca dating back over 500 years of safe use in South America.

Note: consumption of decoctions of Erythroxylum coca are for the most part so benign that there have been few studies on such consumption. Where reports on those studies are available, they are discussed below. To provide additional safety information, some studies of coca chewing are discussed below as well. Since coca chewing leads to more absorption of the Notified Substances than consumption of decoctions of Erythroxylum coca, any reports on the health safety of coca chewing will be even more true so for consumption of decoctions of Erythroxylum coca.

An analogy can be made to nicotine, which is more addictive and toxic than decoctions of Erythroxylum coca. It can take up to 3600 seconds, if not more, for nicotine to enter the brain when chewing nicotine gum, too long to obtain a drug "fix". However, for drug delivery systems such as cigarettes or electronic cigarettes, nicotine can enter the brain in as little as 6 seconds.

The following observations and studies are discussed below:

• Preston curve: Life span of Bolivians versus the United States
• 1995: WHO/UNICRI History of Cocaine Abuse
• 1986: JAMA letter on no dangers when drinking coca tea
• 1971: Coca chewing, mild vasoconstriction and heat retention
• 1965: Dr. Fernando Montesinos, UNODC Bulletin on Narcotics
• 1952: Dr. Martin Cardenas, UNODC Bulletin on Narcotics
• 1901: Gordon Mortimer: "History of Coca - Divine Plant of the Incas"
• 1887: Dr. William Hammond: "Coca: Its Preparations and Therapeutical Qualities"
• 1886: Coca-Cola stops using alcohol but continues using coca leaf
• 1877: Dr. Archie Stockwell: New England Journal of Medicine
• 1876: Sir Robert Christison: British Medical Journal article
• 1875: U.S. Navy: A report on coca or cuca
• 1874: Dr. Alexander Bennett: British Medical Journal article

Together, all of these medical reports prove that consumption of decoctions of Erythroxylum coca have a reasonable certainty of causing no harm.

Preston curve: Life span of Bolivians versus the United States

For decades, if not centuries, citizens of Bolivia have consumed coca tea, the simplest decoction of Erythroxylum coca, and/or have chewed coca leaf. Statistics over the years have shown that about one-third of Bolivians at any one time are consuming coca leaf products. We argue that on health demographic grounds, there is no evidence of negative health effects of consumption of decoctions of Erythroxylum coca. To appreciate this, we turn to global life spans and the Preston curve.

The Preston curve is a graph of life expectancies of most countries of the world versus their GDP per capita. Not surprisingly, the higher the GDP per capita of a country, the longer is the life span of its citizens. As of 2003, Bolivia had a GDP per capita of $2400 and an average lifespan of 65 years, whereas the United States had a GDP of $37800 and an average lifespan of 77 years. If one looks at a graph of the Preston curve for this year prepared by IndexMundi: (see GDP - per capita (PPP) v. Life expectancy at birth), Bolivia is seen to be amidst a group of countries that, if they were able to double their GDP per capita, would move their lifespans from an average of 58 to 67, to an average of 67 to 75, much closer to the average lifespans of far richer countries such as the United States. Additionally, the countries that Bolivia is amongst in this graph do not allow consumption of coca leaf.

Together, this data indicates that widespread consumption of decoctions of Erythroxylum coca has no impact on the life expectancy of the average consumer, with life expectancy being a proxy for a life-long measurement of health. That is, if those countries such as Bolivia and Peru were to double their GDP per capita, their citizen's life expectancy would be indistinguishable from many other countries with similar GDPs but no coca use, and barely distinguishable from countries such as the United States with very high GDPs.

Each year, over 70,000 people in Bolivia die due to the consumption of alcohol   (see: "El alcohol mata cada año a 70,000 personas", La Razon, 10 June 2015, http://www.la-razon.com/sociedad/Estudio-alcohol-mata-ano-personas_0_2286971328.html), while few to no people in Bolivia die due to the consumption of decoctions of Erythroxylum coca. Reducing or eliminating consumption of alcohol in Bolivia would greatly improve demographics and lifespans. Reducing or eliminating consumption of Erythroxylum coca would have no impact on demographics and lifespans.

These uses of coca tea and coca chewing across the centuries in the Andean countries, with no demographic evidence of negative health effects, demonstrates that decoctions of Erythroxylym coca have a reasonable certainty of causing no harm.

1995: WHO/UNICRI History of Cocaine Abuse

In September 1995, in an interim report, the World Health Organization reported on the health and social aspects of coca chewing and the use of cocaine. Medical researchers for WHO did extensive surveys across Latin America, surveying users of coca and cocaine. The report made the following recommendations about coca chewing: for future education and prevention efforts – NONE; for future treatment efforts – NONE; for future research and data gathering – NONE. The only recommendation of the report: "The Program on Substance Abuse and the World Health Organization should undertake a study of the nutritional and therapeutic advantages of the coca leaves." The WHO study could not find enough concerns about coca chewing to warrant further action – coca chewing is not a health or social problem.

A summary of the positive effects of coca chewing as reported in the study:

Coca leaf users described as immediate positive effects the diminution in the sensation of fatigue and an increase in their motivation to work. In a second place, they mention the pleasant taste of the coca leaf and its medicinal properties. These effects and their corresponding evaluation remain constant throughout.

Coca leaf users consider that use has positive effects in the following aspects (in decreasing order of importance). At least half of the sub-sample claim socializing (it includes cultural integration and a sense of belonging), work (increase in productivity), health (it makes one stronger and it has medicinal properties), capacity to deal with living in society (it increases one's courage and strengthens your will), study (it improves one's concentration capacity), livelihood (indirectly, by its effect on work and, directly as a source of income: production, transport and retail sale), helps to avoid accidents (it increases a state of alertness and it diminishes fatigue and sleepiness). Only a few claim that none of the above has improved as a result of use. For most, the aspects most benefited are work, socializing and socio-cultural integration.

As the consumption of decoctions of Erythroxylum coca can expose a person to less coca alkaloids than coca chewing, the lack of health and social problems due to coca chewing will be equally true for consumption of decoctions of Erythroxylum coca. The Intended Uses disclosed in this document are a fulfillment of the 1995 WHO mandate to find nutritional and therapeutic uses of coca leaves.

Excerpts of the WHO report dealing only with coca chewing is available at: www.cienciadelacoca.org/UNCoca1995.html. The full WHO report is available at: https://www.tni.org/files/natural-history-cocaine.pdf.

1986: JAMA letter on no dangers when drinking coca tea

A 1986 article on the Journal of the American Medical Association reports that "Coca tea drinkers did not satisfy the diagnostic criteria for either cocaine intoxication or cocaine abuse, and their claims of 'controlled use' are supported by the weak preparations [of tea]" and "... for most of these [coca] tea drinkers [in the United States], like those in South America, the normal patterns of consumption do not result in ill effects or abuse". See: "Cocaine in Herbal Tea", by Dr. Ronald Siegel et al., J. American Medical Association, v 255 n1 (1986), pg.40 (JAMA abstract at: http://jama.jamanetwork.com/article.aspx?articleid=402364.

1971: Coca chewing, mild vasoconstriction and heat retention

One useful physiological effect of coca chewing is that of inducing mild vasoconstriction, which results in greater heat conservation, which would explain why coca chewers state they feel warmer while chewing coca. In the high, cold climates of the Andes, where people lose much heat through their hands and feet, this effect of mild vasoconstriction saves energy in an environment where food and external heat sources are not readily available. See "Responses of Quechua Indians to Coca Ingestion during Cold Exposure", by Joel Hanna, Am. J. Phys. Anthrop., v34 (1971), pages 273-278 (available at: http://people.stfx.ca/x2006/x2006oei/ANTH%20218%20Paper/Responses%20of%20Quechua%20Indians.pdf).

1965: Dr. Fernando Montesinos, UNODC Bulletin on Narcotics

In an article, "Metabolism of cocaine", in the UNODC Bulletin of Narcotics (1965, Issue 2), Dr. Fernando Montesinos reports on metabolism of the cocaine alkaloid in Peruvian coca chewers. His conclusions are consistent with those of other studies across the centuries: that little coca alkaloid is absorbed by coca chewers because much of the alkaloid is starts to be broken down in mouth, then the gastrointestinal tract, and then further broken down in the liver. He concludes: "2. After ingestion into the organism through the mouth, cocaine undergoes constant hydrolysis, first through the alkali by which it is invariably accompanied, then through the different digestive juices, saliva, gastric juice, pancreatic juice, bile and intestinal juice, giving rise first to benzoyl-ecgonine and finally to ecgonine. ... 3. The original quantity of cocaine is considerably reduced at the moment of absorption together with the intestinal content; the remainder is totally converted into benzoyl-ecgonine and ecgonine in the liver." Given the lower exposure to coca alkaloids, the effects of consumption of decoctions of Erythroxylum coca will result in even less levels of coca alkaloid being absorbed. Article at: http://www.unodc.org/unodc/en/data-and-analysis/bulletin/bulletin_1965-01-01_2_page003.html.

1952: Dr. Martin Cardenas, UNODC Bulletin on Narcotics

In an article, "Psychological aspects of coca addiction", in the UNODC Bulletin of Narcotics (1952, Issue 2), Dr. Martin Cardenas reviews ancedotal studies of coca chewing across the centuries, and dismisses most of the negative conclusions as products of racism, and that they are no negative pyschological effects of coca chewing, once other social factors are controlled for. He concludes with: "These brief remarks are intended to show the Indian of the Andes not as a man degraded by the vice of coca chewing, but as an unhappy, disillusioned human being robbed of his destiny and made helpless by the lack of natural resources with the aid of which he might have covered the stages that separate him from the level of modern civilization."; and "In conclusion, I wish to say that I do not regard as proved the assertion that the Indian's state of mental prostration is the result of coca chewing. Nearly five centuries have elapsed since the Spanish Conquest; in all that time the Indians have gone on chewing coca and yet their mental level does not appear to have been lowered. The use of cocaine for other than medical purposes is to be condemned, but, until I have been proved wrong, I shall not believe that coca chewing is as dangerous as it is said to be." Given the lower exposure to coca alkaloids, the effects of consumption of decoctions of Erythroxylum coca will be even more non-existent. Article at: http://www.unodc.org/unodc/en/data-and-analysis/bulletin/bulletin_1952-01-01_2_page004.html.

1901: Gordon Mortimer: "History of Coca - Divine Plant of the Incas"

One of the classic textbooks on the history, botany, and physiological effects of Erythroxylum coca is Dr. W. Golden Mortimer's "History of Coca - The Divine Plant of the Incas", published in 1901, a time period in which Dr. Mortimer was a member of the New York Academy of Medicine. Chapter 14 of his book is a detailed discussion of the physiological action of coca alkaloids versus cocaine. What follows are a few excerpts from this chapter. Additional excerpts, and links to the full book, are available at: www.cienciadelacoca.org/Mortimer.html.

Commenting on the general safety of consumption of the equivalents of decoctions of Erythroxylum coca, he writes at page 401, "... In the history of Coca, that shrub has been so intimately associated with everyday customs of the simple people of its native land, that its actual merit remained uninvestigated for ages. For aside from the Spanish prejudice against its employment, the use of Coca was so general that any special effort to seriously study its true qualities seemed unnecessary." Indeed, the above discussed WHO study 94 years later concluded much the same - drinking coca tea and chew coca leaf are so harmless as to almost need no further study.

Commenting on why the effects of consumption of the equivalents of decoctions of Erythroxylum coca, such as drinking coca tea, are so extremely different than the effects of cocaine, he writes at page 425: "The action of Coca and cocaine, while similar, is different. Each gives a peculiar sense of well being, but cocaine affects the central nervous system more pronouncedly than does Coca, not -- as commonly presumed -- because it is Coca in a more concentrated form, but because the associate substances present in Coca, which are important in modifying its action, are not present in cocaine. The sustaining influence of Coca has been asserted to be due to its anesthetic action on the stomach, and to its stimulating effect on brain and nervous system. But the strength-giving properties of Coca, aside from mild stimulation to the central nervous system, are embodied in its associate alkaloids, which directly bear upon the muscular system, as well as the depurative influence which Coca has upon the blood, freeing it from the products of tissue waste. This is an important observation to the safe uses of decoctions of Erythroxylum coca, that is, that decoctions of Erythroxylum coca must include more than the methylbenzoylecgonine alkaloid, to be safely consumed in food products.

Commenting on the safety of consumption of the equivalents of decoctions of Erythroxylum coca, he writes at page 431: "It is a noteworthy fact already referred to, that there has been no recorded case of poisoning from Coca, nor cases of Coca addiction commonly regarded as "habit". The cases of cocaine poisoning and addiction often sensationally reported are even open to grave doubt. The condition termed "cocaine habit" is not generally accepted by physicians, as shown in the specific report in the appendix." Again, this is the conclusion of the above discussed WHO study 94 years later, and consistent with the 1986 JAMA letter also discussed above. That is, from the midst of the time period when the coca leaf was actively being studied by doctors such as Dr. Mortimer, to almost 100 years later, when a new generation of doctors reviewed the consumption of products based on the coca leaf, such as coca tea, the safety conclusions were much the same. That is, consumption of the equivalents of decoctions of Erythroxylum coca, and thus the use of decoctions of Erythroxylum coca in food products, is generally recognized as safe.

1887: Dr. William Hammond: "Coca: Its Preparations and Therapeutical Qualities"

In the 1887 edition of the Transactions of the Medical Society of Virginia, Dr. William Hammond, a former Surgeon General of the U.S. Army, reported on the health and safety of those consuming products comprising coca leaf. He reported on consumption three products: a fluid extract of coca leaves, the equivalent of Vin Mariani (a combination of coca leaf and wine), and cocaine hydrochloride. His studies were informal, a collection of his observations, and those of other doctors and researches.

He reports as follows with regards to the fluid extract: "But these matters are antagonistic to the action of cocaine, and present insuperable objections to the employment of the fluid extract when we desire to obtain solely the action of the alkaloid.". The fluid extract is closest in composition to the decoctions of Erythroxylum coca considered in this Notification. With regards to coca wine, he concludes with: "In general, his own experience, coupled with that of other practitioners, establishes the fact that the wine of coca is very valuable as a tonic and stimulant to the weakened or exhausted nervous system. Physicians of eminence likewise speak of it in the highest terms in many such diseases as fevers, dysentery, heart and lung troubles, and especially in malarious disorders. It is very remarkable that its use is not followed by the depression of mind and body that so generally ensue upon the use of other excitants.".

These observations of the safe use of products equivalent to decoctions of Erythroxylum coca are consistent with many others from this time period of the 1880s to 1910, such as those of Gordon Mortimer (discussed above). See: Coca: its preparations and their therapeutical qualities, with some remarks on the so-called 'cocaine habit', Trans. Medical Society of Virginia, v. 18, October 1887, pages 212-226.

1886: Coca-Cola stops using alcohol but continues using coca leaf

Circa 1863, Dr. John Stith Pemberton started manufacturing and selling what is now known as Coca-Cola. Pemberton was inspired by the work of Angelo Mariani, a Parisian chemist who in 1863 combined coca leaf and wine to produce a wine, Vin Mariani, which became very popular on both sides of the Atlantic (one of history's giants of invention, Thomas Edison, was a tremendous devotee of Vin Mariani, as was Pope Leo XIII).

In 1886, Pemberton replaced the alcohol with sugar syrup, as the beginnings of prohibition attitudes against alcohol become more popular. He did not remove the coca leaf, as there were no health concerns at the time for this use of decoctions of Erythroxylum coca.

In 1903, the Coca-Cola company did remove the full coca leaf (modern day colas are made with GRAS-approved decocainized coca leaves). Coca-Cola, to achieve a similar "buzz", added more sugar and caffeine. However, this removal had nothing to do with health concerns for those consuming Coca-Cola (and indeed, use of the full coca leaf was still legal, not being made illegal until 11 years later in 1914). Instead, the removal was mostly made on racist grounds, to quote an The Atlantic article from 13 January 2014: "Middle-class whites worried that soft drinks were contributing to what they saw as exploding cocaine use among African-Americans. Southern newspapers reported that 'negro cocaine fiends' were raping white women, the police powerless to stop them." Atlantic article at: http://www.theatlantic.com/health/archive/2013/01/why-we-took-cocaine-out-of-soda/272694/.

That modern days colas do not include decoctions of Erythroxylum coca has nothing to do with their health concerns. Indeed, their replacement, added sugars such as high fructose corn syrup (now being linked to higher rates of fatty liver disease), has contributed much to the growing global problem of diabetes, which is now costing governments around the world upwards of $1 trillion per year. (note: see Section 6.0.1 on the comparative safety of decoctions of Erythroxylum coca versus sugar when added to food products.)

1877: Dr. Archie Stockwell, New England Journal of Medicine

In "Erythroxylon Coca", (Boston Medical and Surgical Journal, now the New England Journal of Medicine, 5 April 1877, pages 399-404), Dr. Archie Stockwell has one of the first medical journal articles that helps establish "a substantial history of consumption for food use by a significant number of consumers" (with no ill effects, re 21 CFR 170). He writes: "Although there is little or no foreign demand for the article, the local consumption is immense."; and "It is a remarkable fact that those who regularly use the coca require but little food, and with increased indulgence are enabled to undergo the greatest fatigues without tasting anything else."; and "Careful observations lead me to believe that, so far from being injurious, the moderate consumption of coca is not only wholesome but frequently beneficial."; and "In moderate doses, coca causes increased arterial action, stimulates the alimentary secretions and peristaltic action, diminishes weariness, strengthens the pulse, calms nervous excitement, retards waste, facilitates repair, alleviates spasms, and increases mental activity; in fact, it is an economizer of vital energy and an effective aid to nutrition." These safety and health benefits were made for coca chewing. While the health benefits will be lesser so for uses of decoctions of Erythroxylum coca (because of exposure to less coca alkaloid), so to will be lesser any safety concerns. Article at: www.cienicadelacoca.org/GRAS/NEJM1877.pdf.

1876: Sir Robert Christison: British Medical Journal article

An earlier report of mostly positive experiences with coca chewing, was written by Sir Robert Christison, at the time, the president of the British Medical Association, in an article published in the 29 April 1876 edition of the British Medical Journal, titled "iObservations on the effects of cuca, or coca, the leaves of Erythroxlyon coca", available at: www.cienciadelacoca.org/GRAS/BMJ-Christison1876.pdf. He reports on multiple observations of how coca chewing prevented difficulty in breathing at the very high altitudes of the Peruvian Andes (which range from 12,000 to 15,000 feet above sea level). He recounts Von Tschudi observations from 1847, for example: "Von Tschudi observes that, in his own trials, he found it to be a preventive of that difficulty in breathing which is felt in the rapid ascent of the Andes; that, when frequenting the Peruvian Puna, or great desert table-land, 14,000 feet above the level of the sea, a decoction of the leaves enabled him to climb heights, and pursue swift-footed game, with no greater difficulty than in similar rapid exercise on the coast; ...", one of the first such positive reports on decoctions of Erythroxylum coca. Christison, in his paper, reports on his positive experiences: "These trials ... may now be summarized ... These are the following. The chewing of coca removes extreme fatigue and prevents it. Hunger and thirst are suspended; but eventually appetite and digestion are unaffected. ... It has no effect on the mental facilities, so far as my own trials and other observations go, except liberating them from the dullness and drowsiness which follow great bodily fatigue." In the following 140 years, these observations have been reported by many others.

1875: U.S. Navy: A report on coca or cuca

One of the first positive assessments of the health benefits of coca chewing, as determined by the U.S. government, was published in the "Sanitary and Medical Reports" of the U.S. Navy Department. The report was written by Dr. Benjamin Gibbs, a surgeon with the U.S. Navy at the time, and discusses his use and analysis of coca chewing near the northern port city of Arica in Peru.

His observations were consistent with other medical doctors studying coca chewing in that time period: that coca chewing allows the natives to walk great distances at great altitudes ("15,000 to 20,000 feet above the sea") while eating little food. His conclusion, that the coca alkaloids allowed the "extraction of the largest amount of nutriment from the least quantity of food" were later proved to be wrong. Researchers, much later, showed that the coca alkaloids from coca chewing are a very effective hunger suppressant (with long journeys on foot followed by large dinners to compensate for the food not eaten). See: "Report on coca or cuca", Dr. Benjamin Gibbs, U.S. Sanitary and Medical Report for 1873-1874, pages 675-676, available at: www.cienciadelacoca.org/GRAS/CocaUSNavy1875.pdf.

1874: Dr. Alexander Bennett: British Medical Journal

Dr. Alexander Bennett was a doctor in Scotland in the 1870s, and in 1874 published this article, "The Physiological Action of Coca", in which he reviewed earlier articles in the medical journal on therapuetical effects of the coca aklaloid (he refers to the alkaloid as C₁₆H₁₉NO₄, which a few years later was determined to actually be C₁₇H₂₁NO₄, and does not make mention of any salt form). He reported on a series of experiments using 100 animals that compared the effects of coca alkaloid, theine (from tea - later to be shown to be just caffeine), guaranine (from guarana - later to be shown to be just caffeine), caffeine (from coffee - also can be referred to as methyltheobromine) and theobromine (from chocolate) - essentially a comparison of three chemicals. His observations were that the three chemicals had similar physiological effects, produced "cerebral excitement not succeeded by coma", in large doses are all deadly, do not produce muscular paralysis, produce similar respiratory and circulatory effects, with all inducing small temperature changes. More detailed results were reported the previous year in the October 1873 edition of the Edinburgh Medical Journal. Article available at: www.ncbi.nlm.nih.gov/pmc/articles/PMC2296807/pdf/brmedj05140-0008a.pdf.

6.0    REVIEW OF COMPARATIVE SAFETY DATA ON DECOCTIONS OF Erythroxylum coca

To establish a context for a GRAS determination of decoctions of Erythoxylum coca, the following comparisons with other regularly consumed substances should be noted, substances that are explicitly or implicitly GRAS. Unlike alcohol (ethanol), which is GRAS, decoctions of Erythoxylum coca are not an addictive neurotoxin. Unlike nicotine, decoctions of Erythoxylum coca are not a highly addictive pesticide. Unlike sugar (especially fructose), which is GRAS, decoctions of Erythoxylum coca are not an addictive contributory factor for type 2 diabetes.

The acronym - "SCOND" - that is used below refers to the 1961 Single Convention on Narcotic Drugs.

6.0.1    Decoctions of Erythroxylum coca versus Sugar as Food Additives

The second most addictive, deadly narcotic in the world is sugar (using the 1961 SCOND definition of 'narcotic'), the first being nicotine (see section 6.0.6 below), both deadly narcotics not regulated by the 1961 SCOND. Sugar also is the most deadly, addictive, drug that is regularly added to food products. A more concentrated form of sugar (and more dangerous) used in food products is alcohol (see section 6.0.4 below). Table sugar, the first "white powder", chemically known as sucrose, is a disaccharide of glucose and fructose.

Addictive. That sugar is more addictive than drugs such as cocaine can be seen in studies such as "Intense Sweetness Surpasses Cocaine Reward", by Margalie Lenoir et al., PLOS One, volumne 2(8), e698, 01 August 2007, available at: http://www.plosone.org/article/fetchArticle.action?articleURI=info%3Adoi%2F10.1371%2Fjournal.pone.0000698, which reported that a large majority (94%) of test animals (rats) preferred water solutions containing saccharin or sucrose to water solutions containing cocaine. The most commercially used sweet drug, fructose, is even more addictive than sucrose, for example, as reported in "Differential effects of fructose versus glucose on brain and appetitive responses to food cues and decisions for food rewards", by S. Luo et al., Proc. National Academy of Sciences, 4 May 2015, PubMed abstract available at: http://www.ncbi.nlm.nih.gov/pubmed/25941364. See also: "Sugar addiction: pushing the drug-sugar analogy to the limit", by SH Ahmed et al., Curr Opin Clin Nutr Metab Care, vol 16(4), (2013), pages 434-9, PubMed abstract available at: http://www.ncbi.nlm.nih.gov/pubmed/23719144. A database of articles on the dangers to health due to the addictiveness of sugar is available at: www.cienciadelacoca.org/CocaNews.html#SUGAR".

Deadly. That sugar is more deadly than drugs such as cocaine can be seen in the role of added sugars in foods contributing to the global diabetes epidemic. That sugar consumption contributes to diabetes can be seen in studies such as: "High fructose corn syrup and diabetes prevalence: a global perspective", by MI Goran et al., Global Public Health, vol 8(1), (2013), pages 55-64, Pubmed abstract available at: http://www.ncbi.nlm.nih.gov/pubmed/23181629. In turn, diabetes kills almost as many people per year (about 4 million) as does nicotine products, with recent WHO statistics reporting that by 2025, there will be 300 million people in the world with diabetes, with the United States alone spending over $200 billion a year treating diabetes, according to the American Diabetes Association. WHO statistics available at: WHO Fact Sheet 236: Diabetes - the cost of diabetes. ADA statistics available at: ADA: The Cost of Diabetes. Excessive consumption of addictive added sugar in foods is such a global health problem that is starting to lower the growth of GDPs in many economies around the world. See a Morgan Stanley 18 March 2015 analysis: Sustainable Economics: The Bitter Aftertaste of Sugar.

Despite its highly addictive nature and threat to the safety of public health, high fructose corn syrup is GRAS by the U.S. FDA, as regulated by 21 CFR 184.1866 (see http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1866). This acceptance of high fructose corn syrup as GRAS, while causing highly expensive global health problems, in light of the equal protection provisions of the Due Process clause of the U.S. Constitution, supports the acceptance of non-addictive, non-health-problem-causing decoctions of Erythroxylum coca as GRAS.

6.0.2    Decoctions of Erythroxylum coca versus Salt as Food Additives

As mentioned in Section 5.0.3, a 1982 study at the University of Mississippi reported that decoctions of Erythroxylum coca have an LD50 of 3450 millgrams per kilogram (mg/kg). In comparison, common table salt is slightly more toxic, with an LD50 of 3000 mg/kg. Regular consumption of decoctions of Erythroxylum coca thus poses no more toxicity and risk than the regular consumption of salt.

Regular consumption of decoctions of Erythroxylum coca is no more addictive than regular consumption of salt, in that for centuries, consumption of both mostly is a matter of availability, to be started when available and stopped when not. If anything, there is an argument that salt is more addictive than decoctions of Erythroxylum coca, at least as evidenced by the fact that most processed foods have excessive amounts of salt to increase demand for their purchase. This marketing practice has led to excessive consumption of salt around the world. This is enough of a threat to global health that the World Health Organization maintains an ongoing call for reductions in salt consumption, including reductions in the use of salt as a food additive. See: WHO Fact Sheet 393: Salt Reduction. This announcement from WHO was supported in April 2015 with a warning from the U.S Centers for Disease Control, which reported that the majority of food products in the United States have an excessive amount of added salt. See: http://www.cdc.gov/pcd/issues/2015/14_0500.htm.

6.0.3    Decoctions of Erythroxylum coca versus Caffeine as Food Additives

Data suggests that decoctions of Erythroxylum coca should be just as GRAS as caffeine, for at least four reasons. First, both Erythroxlyum coca leaves that are decocainized, and caffeine (see CFR 182.1180), are by statute determined to be GRAS.

Second, caffeine, with an LD50 of 127 mg/kg, is more "toxic" than decoctions of Erythroxylum coca (LD50 of 3450 mg/kg: see section 5.0.3). Indeed, caffeine can be lethal. Sales of caffeine powder is unregulated in the United States, despite the fact a tablespoon of caffeine, when consumed (for example, mixed with water), has killed people. See: "Caffeiene Powder Poses Deadly Risks", New York Times, 19 May 2015, available at: well.blogs.nytimes.com/2015/05/18/caffeine-powder-poses-deadly-risks-2/. In November 2010, the U.S. FDA ordered manufacturers to remove caffeine from alcoholic beverages with added caffeine, which the FDA had determined to be an "unsafe food additive". See: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234109.htm.

Third, caffeine is more "addictive" than decoctions of Erythroxylum coca. Consumption of more than 400 milligrams of caffeine (e.g., a Venti coffee at Starbucks) a day can lead to a dependence, the equivalent of drinking a few large cups of coffee or tea each day. Despite this dependence, coffee and tea, much like coca tea, have been safely consumed for centuries in the Americas. Caffeine is a socially acceptable stimulant drug, which is why it is ingredient in one of the most popular beverages in the world, Coca-Cola and Pepsi. Drinking similar amounts of decoctions of Erythroxylum coca are as, or less, addictive than drinking these caffeine beverages.

Finally, decoctions of Erythroxylum coca, when consumed in/as food beverages, cause similar physiological effects. This similarity can be seen with the following experience. For a few nights, an hour or less before going to sleep, drink a beverage with caffeine, such as coffee or tea. The amount of sleeping will be a bit shorter and/or less restful, due to the caffeine buzz. Now repeat, but drink a beverage with decoctions of Erythroxylum coca, such as coca tea. The disruptions to the sleeping pattern will be similar to that of drinking beverages with caffeine.

These biochemical similarities suggest that caffeine and decoctions of Erythroxylum coca should be similarly GRAS.

6.0.4    Decoctions of Erythroxylum coca versus Alcohol as Food Additives

Alcoholic beverages contain various amounts of ethanol, a neurotoxin. Excessive use of legally available alcohol, just in the United States, kills approximately 100,000 people a year, and the social cost of excessive consumption of alcohol in the United States is over $200 billion a year. Over 10,000 people a year in the United States are killed or murdered by drivers of automobiles who drank excessive amounts of alcoholic beverages (which the organization Mothers Against Drunk Driving have been strenuously fighting). Approximately 15% of the people who regularly consume alcohol become addicted (alcohol is the third most deadly narcotic not regulated by the SCOND). One of the metabolites of alcohol, acetaldehyde, is 30 times more toxic than ethanol, and directly damages DNA. Over 8000 children a year in the United States are born suffering from Fetal Alcohol Syndrome. As of 2006, according to the U.S. CDC, excessive drinking of alcohol cost the United States $223 billion in terms of workplace productivity, health care and law enforcement costs. See: www.cdc.gov/features/alcoholconsumption/. In Bolivia and Peru, excessive drinking of decoctions of Erythroxylum coca costs nothing. Each year, over 70,000 people in Bolivia die due to the consumption of alcohol   (see: "El alcohol mata cada año a 70,000 personas", La Razon, 10 June 2015, http://www.la-razon.com/sociedad/Estudio-alcohol-mata-ano-personas_0_2286971328.html), while few to no people in Bolivia die due to the consumption of decoctions of Erythroxylum coca.

According to CFR 184.1293 (see: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1293), ethanol is recognized by the FDA as GRAS. A database of article on the dangers to health due to alcohol and other legal drugs is available at: www.cienciadelacoca.org/CocaNews.html#LEGAL.

Decoctions of Erythroxylum coca are not neurotoxins. Throughout history, there have been no reports of excessive consumption of decoctions of Erythroxylum coca causing deaths. There is no organization, Mothers Against Coca Tea Drinking. There are no reports of people who regularly consume coca tea becoming addicted. None of the metabolites of coca alkaloids are toxic. There are no indications of a Fetal Coca Tea Syndrome.

This acceptance of ethanol as GRAS, while causing large numbers of deaths, and causing highly expensive global health problems, in light of the equal protection provisions of the Due Process clause of the U.S. Constitution, supports the acceptance of non-addictive, non-health-problem-causing decoctions of Erythroxylum coca as GRAS.

6.0.5    Decoctions of Erythroxylum coca versus Cannabis Extract as Food Additives

The growing de-facto legalization of marijuana in the United States has created a problem of food safety, in that there have been no determinations of the safety of the consumption of marijuana, and there have been no notifications to the FDA under the GRAS program. Despite this lack of knowledge, marijuana is now sold in food products. For example, see: www.foxnews.com/leisure/2015/05/18/marijuana-k-cups-and-coffee-pods-hit-store-shelves/. Any such determinations are at the state level, for example, the State of Colorado's efforts. See: "Colorado introduces new standards for marijuana-infused food", Food Safety News, 25 September 2013, http://www.foodsafetynews.com/2013/09/colorado-introduces-new-rules-on-marijuana-infused-food/. See also, "What about marijuana food safety?", Food Safety News, 20 February 2014, http://www.foodsafetynews.com/2014/02/who-forgot-the-marijuana-food-safety/ .

A database of articles on the growing acceptance of marijuana, and new research into the health benefits of marijuana, is available at: www.cienciadelacoca.org/CocaNews.html#MARIJ

Currently, the FDA is unable to grant GRAS status to marijuana extracts, due to marijuana being classified as a Schedule I drug. When the U.S. government moves marijuana off of Schedule I, there surely will be (successful) filings of GRAS notifications.

To the extent that the use of marijuana in food products is accepted in the United States, implicitly being GRAS until more formal determinations are made, the use of decoctions of Erythroxylum coca should explicitly be GRAS, given the current GRAS status of decocainized coca leaf, and this Notification.

6.0.6    Decoctions of Erythroxylum coca (additive) versus Nicotine (product)

The first most addictive, deadly narcotic in the world is nicotine (using the 1961 SCOND definition of 'narcotic'), the second being sugar (see section 6.0.1 above), both deadly narcotics not regulated by the 1961 SCOND.

In 2012, approximately 437,000 people were killed worldwide. A third of these homicides, about 140,000 deaths, incurred in Latin American and the Caribbean, despite being home to just 8% of the world's population. Many of these homicides in this region can be attributed to cocaine trafficking, which is why multinational governmental efforts must be taken to stop the trafficking of cocaine, and why multinational efforts must be taken to aerially bombard illegal coca leaf farms. See data on homicides around the world maintained by the "Homicide Monitor", available at: http://homicide.igarape.org.br.

By this logic, there must be multinational efforts to stop the trafficking of nicotine, and why multinational efforts must be taken to aerially bombard should-be-illegal tobacco farms. Because each year, addiction to nicotine (a pesticide) leads to 6 million deaths, of which 480,000 deaths occur in the United States, more than all of the homicides in the world. Just in the United States, the economic cost of this addiction is over $300 billion a year. See data on the evils and costs of smoking and tobacco use from the U.S. Center for Disease Control, available at: http://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/. A database of articles on the dangers to health due to the addictiveness of nicotine is available at: www.cienciadelacoca.org/CocaNews.html#NICOT

The acceptance of electronic cigarettes as a consumer product in the United States is tacit acceptance of nicotine as GRAS, especially nicotine liquid products with child-pleasing flavors such as bubblegum, while nicotine remains highly addictive, a pesticide and the cause of multiple diseases. Such government acceptance, in light of the equal protection provisions of the Due Process clause of the U.S. Constitution, supports the acceptance of non-addictive, non-pesticide, non-disease-causing decoctions of Erythroxylum coca as GRAS.

6.0.7    Decoctions of Erythroxylum coca versus Herbs that are GRAS

The FDA has approved some herbs as being GRAS, for those herbs that were in widespread use in food products before 1958. However, some of the herbs are potentially dangerous. For example, the Juniper herb is GRAS in tiny doses (it is used to flavor gin), but consuming repeated doses many cause pain and damage in the kidney. Pennyroyal is GRAS, safe when drunk as tea, toxic to the liver when comsumed in oil form. Rue is GRAS, used as an insect repellent and the oil induces abortion, but in excessive doses is a poison. None of these dangers exist with decoctions of the Erythroxylum coca herb.

7.0    DISCUSSION OF REVIEWED INFORMATION

7.0.1    GRAS Criteria

The FDA defines "safe" or "safety" as it applies to food ingredients as:

"... reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. It is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance." -- See 21 CFR 170.3(i)

Increasing the certainty is achieved with a determination of safety that includes probable consumption of the substance in question, the cumulative effect of the substance, and appropriate safety factors. It is the FDA's operational definition of safety that serves as the framework against which this evaluation is provided.

Furthermore, in discussion GRAS criteria, the FDA notes that:

"... General recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food." -- See 21 CFR 170.30(a): www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=170.30.

"General recognition of safety through experience based on common use in food prior to January 1, 1958, may be determined without the quantity or quality of scientific procedures required for approval of a food additive regulation. General recognition of safety through experience based on common use in food prior to January 1, 1958, shall be based solely on food use of the substance prior to January 1, 1958, and shall ordinarily be based upon generally available data and information." -- See 21 CFR 170.30(c)(1)

The FDA discusses in more detail what is meant by the requirement of general knowledge and acceptance of pertinent information within the scientific community, i.e, the so-called "common knowledge element", in terms of the following two elements:

• Data and information relied upon to establish safety must be generally available, and this is most commonly established by utilizing published, peer-reviewed scientific journals; and
• There must be a basis to conclude that there is consensus (but not unanimity) among qualified scientists about the safety of the substance for its intended use, and this is established by relying upon secondary scientific literature such as published review articles, textbooks, or compendia, or by obtaining opinions of expert panels or opinions from authoritative bodies, such as the National Academy of Sciences.

The World Health Organization is another such authoritative body.

7.0.2    Safety of Decoctions of Erythroxylum coca

7.0.3    Common Knowledge Elements

The first common knowledge element for a GRAS determination requires that data and information relied upon to establish safety must be generally available; this is most commonly established by using studies published in peer-reviewed scientific journals. The majority of studies reviewed in this safety assessment have been published in the scientific literature, as summarized in Section 9.0, "References". Findings from these investigations have been published in peer reviewed journals that are readily available. In addition to the scientific studies that have been conducted and published, history of consumption of decoctions of Erythroxylum coca since the ancient times of the Incans is well known around the world.

Furthermore, safety documentation for food uses of decoctions of Erythroxylum coca are found in publication XXXXXX, which also constitutes information that is generally available for review and evaluation. The composite information noted thereby fulfills the common knowledge element that is required for GRAS determinations.

The second common knowledge element for GRAS determinations requires that consensus exists among qualified scientists that the subject safety assessment is reasonable and appropriate. Qualified scientists in countries that are co-Notifiers for this GRAS determination concur that the intended food uses of decoctions of Erythroxylum coca are considered to be safe.

7.0.4    Foreign Safety Determinations

In Bolivia, the equivalent of the U.S. Food and Drug Administration is a government agency, SENASAG - Servicio Nacional de Sanidad Agropecuaria e Inocuidad Alimentaria (www.senasag.gob.bo - National Service for Agricultural Health and Food Safety in English). Food products can not be sold in Bolivia without the approval of SENASAG. Packaging of food products that have been approved by SENASAG include a registration number issued by the Service. At the SENASAG Web page is available a list of the food products approved by SENASAG that include decoctions of Erythroxylum coca, extracts prepared from leaves of Erythroxylum coca, or their equivalents.

8.0    CONCLUSIONS

Again is quoted: 21 CFR 170.30(c)(2): "A substance used in food prior to January 1, 1958, may be generally recognized as safe through experience based on its common use in food when that use occurred exclusively or primarily outside of the United States if the information about the experience establishes that the use of the substance is safe within the meaning of the Act."

The common use of decoctions of Erythroxylum coca in food products, either as is (for example, with teas) or added to other foods, across the decades and centuries in Bolivia and Peru leads to the conclusion that decoctions of Erythroxylum coca can be Generally Recognized As Safe. This safety is especially true when decoctions of Erythroxylum coca are used in the small amounts for the Intended Use of this Notification, as an additive to de-bitter unsweetened cacao, where the amounts used, to satisfy international regulations, are about one-tenth of one-percent by weight of the total product (for example, a product comprising 10 to 20 grams of unsweetened cacao powder).

9.0    REFERENCES