What happened
Original notice title
Biotek, Inc. MARCS-CMS 539361, March 13, 2018
From the archived source record
Based on our inspection and subsequent review of your firm’s labeling, we 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 [see original source] / in March 2018 and have determined that you take orders there for the products Bio-35 (including Gluten-Free Q Iron-Free), Lipotropic Formula, and ProCal. “They also protect against toxic reaction and heavy metal poisoning.” Lipotropic Formula “Improves Triglyceride Level in Blood” “Lipase enzymatically converts triglycerides, which have a tendency to clog veins and arteries…” “Increases Resistance to Disease” “Lipotropics, in general, help reinforce the thymus gland to increase resistance to disease by: • Increased antibody production • Increased production and action of phagocytes, which surrounds and reduces invading viruses and microbes.*” “Lecithin and sphingomyelin help to keep cholesterol more soluble, deterring buildup of plaque or cholesterol deposits in the blood vessels. 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, Pro-Cal fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Adulterated Dietary Supplements Our investigators observed the following significant violations of FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), which render your dietary supplement products adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(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
- d67842f03893
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.
Sources, dates, and coverage →