Inspections, Compliance, Enforcement, and Criminal Investigations

NutraClipse, Inc 3/31/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD 20740 

 

WARNING LETTER
MAR 31 2016
 
VIA OVERNIGHT DELIVERY, RETURN RECEIPT REQUESTED VIA EMAIL
 
Ralph B. Perry, Jr., Registered Agent
NutraClipse, Inc.
2857 Raleigh Road Parkway
Wilson, NC 27893
 
                                                            Re: 491530
 
Dear Mr. Perry:
 
This letter concerns your product Thermobombs which is labeled and/or offered for sale as a dietary supplement. The ingredient list on your product labeling declares methylsynephrine as a dietary ingredient. This ingredient is also called, among other names, Oxilofrine and p-hydroxyephedrine (hereinafter referred to as methylsynephrine).
 
Under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)], a dietary ingredient is a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. Methylsynephrine is not a vitamin, a mineral, an herb or other botanical, or an amino acid. In addition, according to our research, methylsynephrine is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Finally, methylsynephrine is not a concentrate, metabolite, constituent, extract, or combination of a vitamin; mineral; herb or other botanical; amino acid; or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Accordingly, methylsynephrine is not a dietary ingredient within the definition set forth in section 201(ff)(1) of the Act. Declaring methylsynephrine in your product labeling as a dietary ingredient causes your products marketed as dietary supplements to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading in any particular.
 
Additionally, the ingredient list on your Thermobombs product labeling declares AMP Citrate as a dietary ingredient.  This ingredient is also called, among other names, 1,3-Dimethylbutylamine, 2-amino-4-methylpentane, DMBA, and 4-methyl-2-pentanamine, and will be referred to in the rest of this letter as DMBA.  Given that you have declared DMBA as a dietary ingredient in the labeling of your product, we assume you have a basis to conclude that DMBA is a “dietary ingredient” under section 201(ff)(1) of the Act.  Assuming that DMBA is a "dietary ingredient," it would also be a “new dietary ingredient” (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) under section 413(d) of the Act [21 U.S.C. 350b(d)].
 
Under section 413 of the Act, [21 U.S.C. § 350b], a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the Act [21 U.S.C. § 342(f)] unless it meets one of two requirements:
 
  1. The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
  2. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
To the best of FDA’s knowledge, there is no information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered.  In the absence of such information, DMBA is subject to the notification requirement in section 413(a)(2) of the Act [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6. Because the required notification has not been submitted, your product is adulterated under sections 402(f)(1)(B) and 413(a) of the Act [21 U.S.C. § 342(f)(1)(B) and 350b(a)].
 
Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated.  In the absence of a history of use or other evidence of safety establishing that DMBA, when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe, Thermobombs is adulterated under sections 402(f)(1)(B) and 413(a) of the Act because it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under sections 301(a) and (v) of the Act [21 U.S.C. § 331(a) and (v)]. To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that DMBA will reasonably be expected to be safe when used as a dietary ingredient.
 
It has come to our attention that DMBA used in products in the dietary supplement marketplace may be produced synthetically.  Section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)] defines "dietary ingredient" as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. Synthetically produced DMBA is not a vitamin, mineral, amino acid, herb or other botanical. Additionally, to the best of FDA’s knowledge, synthetically produced DMBA is not commonly used as human food or drink; therefore, it is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, synthetically produced DMBA is not a concentrate, metabolite, constituent, extract or combination of a dietary ingredient.  Therefore, synthetically produced DMBA is not a dietary ingredient as defined in section 201(ff)(1) of the Act.
 
We request that you take prompt action to correct the violation cited above, as well as any other violations associated with your Thermobombs product or other products marketed by your firm that list methylsynephrine and/or DMBA as dietary ingredients in the labeling. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
 
Failure to immediately cease distribution of your Thermobombs product, and any other products you market that list methylsynephrine and/or DMBA as dietary ingredients in the product labeling, could result in enforcement action by FDA without further notice. Sections 302 and 304 of the Act provide for seizure of violative products and injunction against the manufacturers and distributors of violative products [21 U.S.C. §§ 332 and 334]. 
 
Additionally, methylsynephrine is not approved as a food additive or prior sanctioned for use in dietary supplements. Further, FDA's review of this substance does not identify a basis to conclude that the substance is GRAS for use in food. If you contend that this substance is GRAS for use in food, please provide your basis for concluding that methylsynephrine is GRAS for use in dietary supplements, including supporting data or other documentation.
 
We request that you advise us in writing, within 15 days of receipt of this letter, as to the specific steps that have been or will be taken to correct these violations, including any steps taken with respect to product currently in the marketplace. Your response should also include an explanation of each step taken to ensure that similar violations do not recur, as well as documentation to support your response. Your written reply should be directed to Marjorie Davis, United States 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. If you have any questions, please contact Marjorie Davis at Marjorie.Davis@fda.hhs.gov.
 
 Sincerely,                                                                 
 /s/ 
William A. Correll
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
 
cc: info@nutraclipseinc.com
 
6816 Williams Place
Sims, NC 27880
 
4401 Davis Farms Drive
Wilson, NC 27896

 

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