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  5. Dominant Nutrition LLC formerly 8 Weeks Out Labs - 613688 - 10/21/2021
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WARNING LETTER

Dominant Nutrition LLC formerly 8 Weeks Out Labs MARCS-CMS 613688 —

Delivery Method:
Via Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Nancy Abbott
Recipient Title
Owner
Dominant Nutrition LLC formerly 8 Weeks Out Labs

1523 E. Sonterra Blvd #1020
San Antonio, TX 78258
United States

Issuing Office:
Office of Human and Animal Foods West

United States

WARNING LETTER

October 21, 2021

RE: 613688

Dear Nancy Abbott:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at Internet address https://www.dominant-nutrition.com/ in September 2021 and has determined that you take orders there for the products ADIPROPEN ULTRA, SUPERJOINTS, OPTIMUM-CLA, and LipogenX. Based on a review of your website, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and applicable regulations. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Adulterated Dietary Supplement

Labeling on your website at https://www.dominant-nutrition.com/ establishes that you offer for sale your product LipogenX as a dietary supplement and that the product’s Supplement Facts panel declares Hordenine as a dietary ingredient in this product. Hordenine is a dietary ingredient under section 201(ff)(1) of the FD&C Act [21 U.S.C. § 321(ff)(1)]. Further, as a dietary ingredient that was not marketed in the United States before October 15, 1994, Hordenine is a “new dietary ingredient” under section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)].

Under section 413 of the FD&C 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 FD&C 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 Hordenine 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, Hordenine is subject to the notification requirement in section 413(a)(2) of the FD&C 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 FD&C 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 Hordenine, when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe, dietary supplements containing Hordenine as a new dietary ingredient are adulterated under sections 402(f)(1)(B) and 413(a) of the FD&C Act [21 U.S.C. §§ 342(f)(1)(B) and 350b(a)] because 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 product into interstate commerce is prohibited under section 301(a) and (v) of the FD&C 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 Hordenine will reasonably be expected to be safe when used as a dietary ingredient.

Unapproved New Drugs

The claims on your website establish that your products ADIPROPEN ULTRA, SUPERJOINTS, and OPTIMUM-CLA are drugs under section 201(g)(1)(B) of the FD&C Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

On your product webpage for “ADIPROPEN ULTRA”:

  • “ADIPROPEN ULTRA is our new and improved version of Adipropen with added Vinpocetine, commonly referred to as ‘Viagra for the Brain.’ [I]t is more effective than Clenbuterol.”

On your product webpage for “SUPERJOINTS”:

  • “SUPERJOINTS contains an amazing healing extract called Cissus Quadrangularis that has the miraculous ability to relieve joint pain and heal joint damage. Used for centuries as medicine, Cissus Quadrandularis can speed joint fracture healing rates . . .. It also aids in healing tendons and ligaments in even the most stubborn cases.”

On your product webpage for “OPTIMUM-CLA”:

  • “Conjugated linoleum Acid (CLA): is a potent . . . anti-carcinogen, and anti-catabolic . . . Some of the common accolades of CLA are . . . is a cancer fighter.”

Your products ADIPROPEN ULTRA, SUPERJOINTS, and OPTIMUM-CLA 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 FD&C 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 the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

Misbranded Drugs

A drug is misbranded under section 502(f)(1) of the FD&C 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 FD&C 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 product OPTIMUM-CLA is 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 product safely for its intended purpose. Accordingly, OPTIMUM-CLA fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the FD&C Act [21 U.S.C. 331(a)].

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed 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 and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, Office of Human and, Animal Food Operations West Division 3, Attention: Dana Lewis, 1201 Main St, Suite 7200, Dallas, Texas 75202 or by email to Dana.Lewis@fda.hhs.gov. If you have questions regarding this letter, please contact Dana Lewis at (214) 253-5205.

Sincerely,
/S/
Edmundo Garcia Jr.
Director, Division III
Office of Human and Animal Foods West

 
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