Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm494007.htm
Timestamp: 2019-04-26 01:45:21
Document Index: 747152100

Matched Legal Cases: ['§ 321', '§ 343', '§ 342', '§ 355', '§ 321', '§ 331', '§ 331', '§ 332', '§ 321', '§ 331']

Andrew Dean Mc Michael, President
2607 N. River Hills RD.,
Re: 491535
Dear Mr. Mc Michael:
This letter concerns your product Fat Burning Lean Pills which is labeled and/or offered for sale as a dietary supplement. The product labeling for your Fat Burning Lean Pills 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 product labeling for your Fat Burning Lean Pills declares methylhexanamine as a dietary ingredient. This ingredient is also called, among other names, dimethylamylamine, DMAA, or 1,3-dimethylamylamine and will be referred to in the rest of this letter as "methylhexanamine". Methylhexanamine is not a dietary ingredient. Rather, it is an unsafe food additive that causes your methylhexanamine-containing product to be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C § 342(a)(2)(C)(i)] because it is a food to which methylhexanamine, a drug approved under section 505 of the Act [21 U.S.C. § 355], has been added.
Although some marketers of dietary supplements containing methylhexanamine have argued that methylhexanamine is a dietary ingredient under section 201(ff)(1) of the Act because (1) it is a constituent of a botanical, namely the geranium Pelargonium graveolens (P.graveolens), under section 201 (ff)(1)(C) or (F) because methylexanamine is not an herb or other botanical, nor is it a constituent of a botanical. Further, FDA has reviewed scientific literature and has concluded that the totality of the scientific evidence does not demonstrate the presence of methylhexanamine in P. graveolens. 1 Therefore, methylhexanamine is not a constituent of P. graveolens that could qualify as a dietary ingredient under section 201 (ff)(1)(F).
Additionally, methylhexanamine does not qualify as a dietary ingredient under section 201 (ff)(1)(E) of the Act because, to the best of FDA's knowledge, no evidence exists that methylhexanamine is a dietary substance for use by man to supplement the diet by increasing total dietary intake. Because the scientific evidence does not demonstrate the presence of methylhexanamine as a constituent of geraniums, the possibility that geraniums may have been consumed as a food or drink by humans does not demonstrate that methylhexanamine is a dietary substance. Further, to the best of FDA's knowledge, methylhexanamine itself is not commonly used as a food or drink by humans.
Finally, methylhexanamine does not qualify as a dietary ingredient under any other prong of section 201 (ff)(1) of the Act. Methylhexanamine is not a vitamin, mineral, amino acid, herb, or other botanical. Moreover, to the best of FDA's knowledge, methylhexanamine is not a concentrate, metabolite, constituent, extract or combination of a dietary ingredient.
If a substance is not generally recognized as safe (GRAS) by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition, 2 it is a food additive. Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the Act. Adulterated foods cannot be legally imported or marketed in the United States.
Section 201(s) of the Act [21 U.S.C § 321(s)] exempts dietary ingredients used in dietary supplements from the food additive definition. However, non-dietary ingredients intended for use in dietary supplements, such as the methylhexanamine used in your products, are not exempt from the food additive definition and must meet the same requirements as substances added to conventional foods. In other words, a non-dietary ingredient added to a dietary supplement must be used in accordance with a food additive regulation or be GRAS for its intended use, unless it qualifies for another exception to the food additive definition.
Methylhexanamine is not generally recognized as safe under its conditions of use in your dietary supplement product. In fact, methylhexanamine is known to have cardiovascular risks. It narrows the blood vessels and arteries, which increases cardiovascular resistance and frequently leads to elevated blood pressure. This rise in blood pressure may increase the work of the heart such that it could precipitate a cardiovascular event, which could range from shortness of breath to tightening of the chest and/or a possible myocardial infarction (heart attack). Because methylhexanamine does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your Fat Burning Lean Pills product is adulterated under section 402(a)(2)(C)(i) of the Act because it contains an unsafe food additive.
The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under section 301(a) of the Act [21 U.S.C. § 331(a)). Further, it is a prohibited act under section 301(ll) of the Act [21 U.S.C. § 331(ll)] to introduce or deliver for introduction into interstate commerce any food to which a drug approved under section 505 of the Act has been added, unless the added drug was marketed in food before being approved under section 505.3 Methylhexanamine was approved as a drug in 1948 under section 505 of the Act and, to the best of FDA's knowledge, was not marketed in food prior to such approval, either on its own or based on its alleged presence as a component of P. graveolens. In the absence of such evidence, your Fat Burning Lean Pills product is in violation of section 301 (II) 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 Fat Burning Lean Pills product or other products marketed by your firm that list methylsynephrine and/or dimethylamylamine 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 Fat Burning Lean Pills product, and any other products you market that list methylsynephrine and/or dimethylamylamine 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, we note that 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.
105 Tradesman Dr. Suite B
4625 San Felipe, Suite 1100
1. FDA’s review of the scientific literature on this topic is summarized in a letter to USPlabs, LLC, dated April 18, 2013. The letter is posted on the agency’s website at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/ucm350199.htm2.
2. Under section 201(s) of the FD&C Act [21 U.S.C. § 321(s)], the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food; (2) pesticide chemicals; (3) color additives; (4) substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the Act, the Poultry Products Inspection Act, or the Meat Inspection Act; (5) new animal drugs; and (6) dietary ingredients in or intended for use in a dietary supplement.
3. Section 331 (II) also contains other exceptions not relevant here. See 21 U.S.C. § 331(II)(2)-(4).