What happened
Original notice title
Lose Fat Gain Life M&B MARCS-CMS 594850, April 16, 2020
From the archived source record
Based on laboratory analysis of your product and a review of your product labeling, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Adulterated Dietary Supplements: Unsafe Food Additive Your Skinny Pill product is adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] because it contains 1,3-dimethylamylamine (DMAA), an unsafe food additive under section 409(a) of the Act [21 U.S.C. § 348(a)]. 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)]. Because DMAA does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your Skinny Pill 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)]. FDA has also issued a warning to consumers not to use Skinny Pill (see Skinny Pill Immediate Public Notification). Unapproved New Drug and Misbranded Drugs FDA reviewed your website at www.losefatgainlifemb.com in March 2020 and has determined that you take order there for the products Reishi Coffee, Sugar Control, Blood Pressure Support, Fat Burner, Hear Clear Ear Health Formula, Hemp Oil, Liquid Gold, Omega 3, and Ovary Care. 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). Accordingly, Reishi Coffee, Sugar Control, Blood Pressure Support, Fat Burner, Hemp Oil, Liquid Gold, Omega 3, and Ovary Care 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)].
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 58623f8dee2e
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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