Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
MAR 31 2016
VIA OVERNIGHT DELIVERY, RETURN RECEIPT REQUESTED VIA EMAIL
Mathew W. Maynard
M4 Nutrition Companies, LLC
7324 Gaston Ave Ste 124-422
Dallas, TX 75214-6126
Dear Mr. Maynard:
This letter concerns your product iBurn 2 which is labeled and/or offered for sale as a dietary supplement. The product labeling for your product iBurn 2 declares methylsynephrine and picamilon as dietary ingredients. The ingredient methylsynephrine is also called, among other names, Oxilofrine and p-hydroxyephedrine (hereinafter referred to as methylsynephrine). The ingredient picamilon is also called, among other names, pikatropin, pikamilon, nicotinyl-gamma-aminobutyric acid, and nicotinoyl-GABA (hereinafter referred to as picamilon).
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 and picamilon are not vitamins, minerals, herbs or other botanicals, or amino acids. In addition, according to our research, methylsynephrine and picamilon are not dietary substances for use by man to supplement the diet by increasing the total dietary intake. Finally, methylsynephrine and picamilon are not concentrates, metabolites, constituents, extracts, or a combination of vitamins; minerals; herbs or other botanicals; amino acids; or dietary substances for use by man to supplement the diet by increasing the total dietary intake. Accordingly, methylsynephrine and picamilon are not dietary ingredients within the definition set forth in section 201(ff)(1) of the Act. Declaring methylsynephrine and picamilon in your product labeling as dietary ingredients 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.
We request that you take prompt action to correct the violation cited above, as well as any other violations associated with your iBurn 2 product or other products marketed by your firm that list methylsynephrine and/or picamilon as dietary ingredients in the product 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 iBurn 2 product, and any other products you market that list methylsynephrine and/or picamilon 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 and picamilon are not approved as food additives or prior sanctioned for use in dietary supplements. Further, FDA's review of these substances does not identify a basis to conclude that the substances are GRAS for use in food. If you contend that these substances are GRAS for use in food, please provide your basis for concluding that methylsynephrine and picamilon are 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 Aaron Dotson, 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 Aaron Dotson at firstname.lastname@example.org.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition
This page was posted on March 28, 2019.