What happened
Original notice title
1st Phorm LLC MARCS-CMS 613715, July 29, 2021
From the archived source record
Based on our review of your website, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs / Misbranded Drugs FDA reviewed your website at the Internet address www.1stphorm.com in March 2021 and has determined that you take orders there for your products Whole Heart Cardiovascular Health Formula and Full-Mega Omega-3 Fish Oil. “Whole Heart is a pharmaceutical-grade blend of ingredients designed to . . . combat cardiovascular disease and heart attacks.” “[The natural substances in Whole Heart are also key components in helping treat arthritis and other common issues like acne and skin-diseases.” “We formulated Whole Heart to help decrease unhealthy levels of LDL cholesterol.” ” Regular use ofWhole Heart can revamp your body’s blood flow and help decrease cholesterol production.” “Narrowing of the arteries increases resistance can lead to high blood pressure, the silent killer. 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, Whole Heart Cardiovascular Health Formula and Full-Mega Omega-3 Fish Oil products 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 MegaWatt V2, Thyro-Drive, 1-Db Overdrive Fastpack, 1-Db Goddess, and 1-Db Overdrive & Thyro-Drive products are adulterated within the meaning of section 413(a) of the Act [21 U.S.C. § 350b(a)]. Under section 413(a) of the Act [21 U.S.C. § 350b(a)], a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the Act [21 U.S.C. § 342(f)] unless it meets one of two requirements: 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
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- 672202e12b83
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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