WARNING LETTER
New York Nutrition Company / American Metabolix
MARCS-CMS 611994 —
August 31, 2021
Delivery Method:
UPS Overnight
Product:
Food & Beverages
Recipient:
Recipient Name
Jason Duran/Markus Trillsch
Recipient Title
Owners
New York Nutrition Company / American Metabolix
1083 FM 812 Unit B
Cedar Creek
,
TX
78612-3689
United States
Issuing Office:
Division of Human and Animal Food Operations West III
United States
August 31, 2021
WARNING LETTER
Ref. # CMS 611994
Dear Jason Duran and Markus Trillsch,
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at http://americanmetabolix.com in June 2021 and has determined that you take orders for the products Muscle Test, Banish, Ketogenic Diet Aid, Keto Friendly Collagen, Exile Euphoric Weight Loss, Exile Super Shock, Havok Hardcore, and Keto Pump in Watermelon and Grape Flavors. The claims on your website establish that the Muscle Test, Banish, Ketogenic Diet Aid, and Keto Friendly Collagen products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. In addition, as explained further below, the Exile Euphoric Weight Loss, Exile Super Shock, Havok Hardcore, and Keto Pump in Watermelon and Grape Flavors products are adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(2)(C)(i)].
As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Unapproved New and Misbranded Drugs
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Muscle Test
On your product page for Muscle Test at http://americanmetabolix.com:
"Avena Sativa [an ingredient in your Muscle Test product] – Considered by many to be the ‘Natural Viagra’ . . . . Can increase sexual desire, and restore nerves"
"Diindolynmethane [sic] [an ingredient in your Muscle Test product] . . . Also has some anti-cancer properties."
"White Button Mushroom [an ingredient in your Muscle Test product] …Used widely in breast cancer applications to prevent spread of the disease."
Banish
On your product page for Banish at http://americanmetabolix.com:
“[W]ith . . . enhanced blood sugar regulation"
“Unmatched in blood sugar balancing, our combination of Bitter melon extract and chromium [ingredients in your Banish product] . . . controls blood sugar spikes.”
Ketogenic Diet Aid
On your product page for Ketogenic Diet Aid at http://americanmetabolix.com:
“Zinc Gluconate [an ingredient in your Ketogenic Diet Aid product] . . . boosting dietary zinc may benefit . . . obese individuals.”
"Guggulsterones [an ingredient in your Ketogenic Diet Aid product] . . . reducing the cholesterol levels in the body."
“Kelp (Iodine) [an ingredient in your Ketogenic Diet Aid product] . . . The high level of iodine in kelp means that it can help address thyroid disorders.”
Keto Friendly Collagen
On your product page for Keto Friendly Collagen at http://americanmetabolix.com:
“REPAIR JOINT, TENDONS & CARTILAGE: When we lose collagen, our cartilage, ligaments, and connective tissue start moving with less ease, leading to stiffness, swollen joints and more. Adding hydrolyzed collagen [an ingredient in your Keto Friendly Collagen] . . . helps your joints move more easily, . . . reduces pain, and rebuilds and repairs connective tissue”
Your Muscle Test, Banish, Ketogenic Diet Aid, and Keto Friendly Collagen products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your Muscle Test and Ketogenic Diet Aid products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Muscle Test and Ketogenic Diet Aid fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
Adulterated Dietary Supplements
Your Exile Super Shock, Havok Hardcore BombSicle, and Keto Pump in Watermelon and Grape Flavors are labeled as dietary supplements and offered for sale on your website, http://americanmetabolix.com. The Supplement Facts label for each of these products lists Hordenine Hydrochloride (HCl) as an ingredient, and the Supplement Facts label for your Exile Super Shock product also lists Higenamine Hydrochloride (HCl) as an ingredient.
As such, your Exile Super Shock, Havok Hardcore BombSicle, and Keto Pump in Watermelon and Grape Flavors products are adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(2)(C)(i)] because the ingredients Hordenine HCl and Higenamine HCl are unsafe food additives under section 409(a) of the Act [21 U.S.C. 348(a)]. If a substance added to food 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, it is a food additive.
1
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 [21 U.S.C. 342(a)(C)(i)].
The definition of “food additive” in section 201(s) of the Act [21 U.S.C § 321(s)] does not include dietary ingredients used in dietary supplements as defined in section 201(ff)(1) of the Act [21 U.S.C. 321(ff)(1)] or substances that are GRAS under the conditions of intended use. The ingredients Hordenine HCl and Higenamine HCl do not qualify as dietary ingredients under section 201(ff)(1) of the Act [21 U.S.C. 321(ff)(1)] because they are not vitamins, minerals, amino acids, herbs or other botanicals, dietary substance for use by man to supplement the diet by increasing the total dietary intake, or concentrate, metabolite, constituent, extract, or combination of any of the preceding dietary ingredient types.
Neither are Hordenine HCl and Higenamine HCl GRAS under their conditions of use in your dietary supplement products. Because Hordenine HCl and Higenamine HCl do not qualify as dietary ingredients and are not GRAS or otherwise exempt from the food additive definition, your Exile Super Shock, Havok Hardcore BombSicle, and Keto Pump in Watermelon and Grape Flavors products are adulterated under section 402(a)(2)(C)(i) of the Act because they contain 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)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to Chad J. Whitwell, Compliance Officer, U.S. Food and Drug Administration, 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues in this letter, please contact Mr. Whitwell at Chad.Whitwell@fda.hhs.gov or by phone at 214-253-5328.
Sincerely,
/S/
Edmundo Garcia, Jr.
Program Division Director HAF West 3
Dallas District Director
_____________________________
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Under section 201(s) of the 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.
Content current as of:
09/14/2021
Regulated Product(s)
Food & Beverages