DEWMAR INTERNATIONAL BMC, INC 3/27/14
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
March 27, 2014
WARNING LETTER NO. 2014-NOL-13
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Marco Moran, President
Dewmar International BMC, Inc.
101 Convention Center Drive, Suite 700
Las Vegas, Nevada 89109
Dear Mr. Moran:
The Food and Drug Administration (FDA) has reviewed the regulatory status of the ingredients declared on the label of your beverage products, Lean Slow Motion…Potion (Easta Pink, Purp, and Yella varieties) and has determined your products are adulterated under Section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(a)(2)(C)] because they bear or contain an unsafe food additive. Specifically, the products contain 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 Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403 of the Act [21 USC 343]. You may find the Act and FDA regulations through links at FDA’s Internet home page at www.fda.gov
Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are represented for use as conventional foods, and accordingly are not dietary supplements, 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” below the Nutrition Facts panel on your product labels does not make your products dietary supplements, because your Lean Slow Motion…Potion products are represented for use as conventional foods. Examples of factors and information that establish that the products are represented for use as conventional foods are as follows:
- Your products are described as beverages on the information panels of the cans.
- The “Products” page on your website describes your Yella product as for people who like “pineapple-based Fanta” carbonated soft drink, your Purp product as for people who “like it raw mixed with Sprite” carbonated soft drink and your Easta Pink product as inspired by “Sprite Easta Pink.”
- The homepage of your website, www.slowmotionpotion.com, refers to your line of products as, “#1 relaxation beverage” and “the most potent relaxation drink.”
- The “Products” page on your website describes the flavor of your Yella product as having a “hint of red Jolly Rancher flavor” and “unique flavor combination that is ranked number 1 in blind taste tests.” The page describes the flavor of your Purp product as including “grape Jolly Rancher candy.” The page describes the flavor of your Easta Pink product as “a secret flavor combination” that “creates the sweetest of the Leans.”
- Your products, sold in single-serving pop-top aluminum cans, have the appearance and packaging of carbonated soft drinks.
- Your products contain a Nutrition Facts label.
- Your products are comprised of typical ingredients for carbonated soft drinks (carbonated water, sugar, citric acid, natural flavor, potassium sorbate, sodium benzoate) plus melatonin and extracts.
- The president’s message on your company website at www.dewmarinternational.com/presidents-message/ refers to your products as “relaxation beverages” and a “beverage brand.”
Unapproved Food Additive
Any substance added to a conventional food, such as your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) beverage products, 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 General 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 “Lean Slow Motion…Potion (Easta Pink, Purp, and Yella),” 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 “Lean Slow Motion…Potion (Easta Pink, Purp, and Yella)” products 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 “Lean Slow Motion…Potion (Easta Pink, Purp, and Yella)” products are adulterated within the meaning of Section 402(a)(2)(C) of the Act [21 USC 342(a)(2)(C)].
Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403(a)(1) of the Act [21 USC 343(a)(1)]. As discussed above, the products are represented for use as conventional foods, however, below the Nutrition Facts panel, the labels state: “DIETARY SUPPLEMENT.”
Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403 (i)(1) of the Act [21 USC 343(i)(1)] because they fail to bear a statement of identity in accordance with 21 CFR 101.3.
Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403(q) of the Act [21 USC 343(q)] because the nutrition information is not in an appropriate format, as specified in 21 CFR 101.9. For example:
- A declaration of “Acai Berry Extract” is not allowed within the nutrition label (e.g., 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 amounts of saturated fat and trans fat are not declared as provided for in either of the methods specified in 21 CFR 101.9(c)(2)(i) and 21 CFR 101.9(c)(2)(ii) or 21 CFR 101.9(f)(4). Further, the amount of cholesterol is not declared as provided for in either of the methods specified in 21 CFR 101.9(c)(3) or 21 CFR 101.9(f)(4).
- 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 the labels fail to use this statement to declare trans fat, saturated fat, cholesterol, vitamins A and C, iron and calcium.
This letter is not intended to be an all-inclusive list of violations in 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 FDA taking regulatory action without further notice, such as seizure or injunction.
You should respond in writing within 15 working days from the date you receive this letter. Your response should include specific steps you have taken to correct the noted violations, 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 your planned correction will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
Your response should be sent to: Ms. Kimberly Dutzek, Compliance Officer, at the address above. If you have any questions about the content of this letter, please contact Ms. Dutzek at (615) 366-7826.
Patricia K. Schafer
New Orleans District
cc: John F. Johnson III, Esq., Associate
Benjamin L. England & Associates, LLC
810 Landmark Drive, Suite 126
Glen Burnie, Maryland 21061
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.