Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|5100 Paint Branch Parkway|
College Park, MD 20740
MAR 4, 2015
Via UPS Overnight Delivery Service
Brian Weber, CEO
Bebida Beverage Company (BeBevCo)
125F Trade Ct # 9
Mooresville, NC 28117-5539
Re: # 443517
Dear Mr. Weber:
The United States Food and Drug Administration (FDA) has reviewed the regulatory status of the ingredients declared on the label of your beverage product, “Koma Unwind Liquid Relaxation”, and has determined your product is adulterated under Section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(a)(2)(C)(i)] because it bears or contains an unsafe food additive. Specifically, your product contains melatonin (5-methoxy-N-acetyltryptamine, CAS Reg. No. 73-31-4), which is a neurohormone and is an unapproved food additive under Section 409 of the Act [21 USC 348]. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations, Part 170 (21 CFR 170). Additionally, based on our review of your product labels, your “Koma Unwind Liquid Relaxation 12 oz.” product is misbranded within the meaning of Section 403 of the Act [21 USC 343] as described further below. You may find the Act and FDA regulations through links at FDA’s Internet home page at www.fda.gov.
Your “Koma Unwind Liquid Relaxation 12 oz.” product is represented for use as a conventional food, and accordingly is not a dietary supplement, as defined under Section 201(ff) of the Act [21 USC 321(ff)]. The Act excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet [21 USC 321(ff)(2)(B)]. Your use of the term “Dietary Supplement” on the principal display panel of your product label does not make your product a dietary supplement, because your “Koma Unwind Liquid Relaxation 12 oz.” product is represented for use as a conventional food. The following are examples of factors that establish your product is represented for use as a conventional food:
- Your product is described as a “lightly carbonated beverage” on your website at http://bebevco.com/
- The “Media” page on your website http://bebevco.com/ has your product featured in Beverage Manager Magazine
- The homepage of your website, http://bebevco.com/, refers to your line of products as, “relaxation and energy beverages” and “relaxation drink.”
- The “News - BeBevCo Adds Distribution Partner for KOMA Unwind” page on your website http://bebevco.com/ describes your product as “Koma Unwind Liquid Relaxation, (beverage)…”
- The “About Us” page on your website http://bebevco.com/ states “The relaxation or “anti-energy” drink category is new to the beverage industry. This type of drink is dedicated to helping consumers achieve a level of relaxation without the use of pills or alcohol. Bebida Beverage Company is excited to introduce their [sic] own prestigious brand of relaxation beverage through Koma Unwind.... These drinks are predicted to be a huge success.”
- Your product is sold in a single-serving pop-top 12 oz. aluminum can and has the appearance and packaging of a carbonated soft drink
- Your product contains a Nutrition Facts label
- Your product is comprised of typical ingredients for carbonated soft drinks (i.e., carbonated water, high fructose corn syrup, citric acid, artificial flavor, potassium sorbate, grape juice from concentrate)
Unapproved Food Additive
Any substance added to a conventional food, such as your “Koma Unwind Liquid Relaxation 12 oz.” product, must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)]. There is no food additive regulation that authorizes the use of melatonin. We are not aware of any information to indicate that melatonin is the subject of a prior sanction (see 21 CFR 181). As explained below, we are not aware of any basis to conclude that melatonin is GRAS for use in conventional foods.
FDA's regulations in 21 CFR 170.30(a)-(c) describe criteria for eligibility for classification of a food ingredient as GRAS. General recognition of safety must be based only on the views of qualified experts. The basis of such views may be either (1) scientific procedures, or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. In addition, 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.
- Under 21 CFR 170.3(h), “[s]cientific procedures include those human, animal, analytical, and other scientific studies, whether published or unpublished, appropriate to establish the safety of a substance.” Under 21 CFR 170.30(b), “[g]eneral recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient.” Section 170.30(b) further states that general recognition of safety through scientific procedures is ordinarily based upon published studies, which may be corroborated by unpublished studies and other data and information.
- Under 21 CFR 170.3(f), “[c]ommon use in food means a substantial history of consumption of a substance for food use by a significant number of consumers.” Under 21 CFR 170.30(c)(1), “[g]eneral 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.” Importantly, however, the fact a substance was added to food before 1958 does not, in itself, demonstrate such use is safe, unless the pre-1958 use is sufficient to demonstrate to qualified experts that the substance is safe when added to food [21 CFR 170.30(a)].
- Under 21 CFR 170.3(i), “[s]afe or safety means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” The regulation provides that, in determining safety, the following factors are to be considered: (1) The probable consumption of the substance and of any substance formed in or on food because of its use; (2) the cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet; and (3) safety factors which, in the opinion of qualified experts, are generally recognized as appropriate. Such safety factors ordinarily are established through extensive testing in animals to determine whether consumption of the ingredient produces adverse effects when consumed chronically (i.e., on a daily basis over the course of a lifetime).1
We know of no basis for general recognition of safety for melatonin based either on scientific procedures or common use in food prior to January 1, 1958. Melatonin is a neurohormone that is used for medicinal purposes, primarily as a sleep aid in the treatment of sleep-related disorders. In assessing the GRAS status of melatonin for use in a conventional food such as “Koma Unwind Liquid Relaxation,” we considered the criteria described above. FDA is not aware of data to establish the safety of melatonin for use as an ingredient in conventional foods. On the contrary, reports in the scientific literature have raised safety concerns about the use of melatonin. Among these are concerns about effects on blood glucose homeostasis (References 1- 4), and effects on the reproductive/developmental (References 5- 11), cardiovascular (References 12- 18), ocular (References 19- 21) and neurological systems (References 22, 23). Therefore, the use of melatonin in your “Koma Unwind Liquid Relaxation” product does not satisfy the criteria for GRAS status under 21 CFR 170.30.
FDA is not aware of any other exemption from the food additive definition that would apply to melatonin for use as an ingredient in a conventional food, such as your beverage product. Therefore, melatonin added to a conventional food is a food additive under Section 201(s) of the Act [21 USC 321(s)] and is subject to the provisions of Section 409 of the Act [21 USC 348]. Under Section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Melatonin is not approved for use in any food, including beverages. Therefore, your “Koma Unwind Liquid Relaxation” product is adulterated within the meaning of Section 402(a)(2)(C)(i) of the Act [21 USC 342(a)(2)(C)(i)].
1. Your “Koma Unwind Liquid Relaxation 12 oz.” product is misbranded within the meaning of Section 403(a)(1) of the Act [21 USC 343(a)(1)]. As discussed above, the product is represented for use as a conventional food; however, the label falsely identifies the product as a dietary supplement.
2. Your “Koma Unwind Liquid Relaxation 12 oz.” product sold to individual customers is misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the label fails to bear a statement of identity on the Principal Display Panel, in accordance with 21 CFR 101.3.
3. Your “Koma Unwind Liquid Relaxation 12 oz.” product is misbranded within the meaning of Section 403(q) of the Act [21 USC 343(q)] because the nutrition information is not declared in an appropriate format, as specified in 21 CFR 101.9. For example:
- The product label fails to declare the serving size in accordance with 21 CFR 101.9(b)(6) in that the entire can must be considered a single serving container and labeled as one serving. A product that is packaged and sold individually and that contains less than 200 percent of the applicable reference amount shall be considered to be a single-serving container and the entire content of the product shall be labeled as one serving.
- A declaration of “Milk Thistle, Valerian Root, and Rose Hips Extract” is not permitted within the nutrition label (i.e., Nutrition Facts panel). According to 21 CFR 101.9(c), no nutrients or food components other than those listed in 21 CFR 101.9(c) as either mandatory or voluntary may be included within the nutrition label.
- The label uses the simplified Nutrition Facts labeling format under 21 CFR 101.9(f). When using this format, the declaration of voluntary nutrients triggers the requirement that the statement “Not a significant source of ___” be included at the bottom of the nutrition label. We note your label fails to use this statement to declare Trans Fat, Saturated Fat, Cholesterol, Dietary Fiber, Vitamins A and C, Calcium and Iron.
This letter is not intended to be an all-inclusive list of violations that exist in connection with your products. It is your responsibility to ensure all of your products comply with the Act and other applicable regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure or injunction.
In addition to the above violations, we also have the following comments:
- The label includes the disclaimer "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." This disclaimer applies to the label or labeling of dietary supplements that bear a claim under section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] and 21 CFR 101.93(b) and should not be used on the label or labeling of conventional foods.
- Your “Koma Unwind Liquid Relaxation 12 oz.” product fails to declare the street address. The current label lists the location of the business as Mooresville, NC 28117. The statement of the place of business shall include the street address, city, State, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory, as required by 21 CFR 101.5(d).
Please respond in writing within fifteen (15) working days from the date you receive this letter. Your response should include specific steps you have taken to correct the violations described above, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.
Your written reply should be directed to Rob Genzel Jr., CSO, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition
Brian Weber, CEO
1304 N. Barkley Rd
Statesville, NC 28677 US
1 Guidance for Industry and Other Stakeholders: Toxicological Principles for the Safety Assessment of Food Ingredients, Redbook 2000, available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/default.htm.