What happened
Original notice title
Positive Power Nutrition 9/15/16
From the archived source record
Based on our inspection and subsequent review of your product labeling collected during the inspection, we found significant violations of the Federal Food, Drug and Cosmetic Act (the Act) and applicable regulations. New Drugs/Misbranded Drugs FDA has reviewed labeling for your products High Energy C-Complex, Positive Vitality, Positive Performance, Positive CardioGuard, B-Complex 100, Positive Essentials, Positive Energy Boosters, Omega-3 Marine Lipid Oil, B-12 Booster Shot, Cell Power, and Super Silica obtained during our inspection of your facility. Silica supplementation may be useful for people who have concerns similar to the following ... Heavy Metal Toxicity ... effective in regulating plaque deposits in artery walls and it is abundant (up to 14 times more) in the arteries of people who are free from heart disease ... can help with wound and bum healing ... an important therapeutic substance for many diseases ... " • "Cellular Oxygenation and Detoxification may be useful for people who have concerns similar to the following ... A drug is misbranded under section 502(t)(l) of the Act [21 U.S.C. § 352(t)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, these products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(t)(1) of the Act [21 U.S.C. § 352(t)(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 Even if your products High Energy C-Complex, Positive Vitality, Positive Performance, Positive CardioGuard, B-Complex 100, Positive Essentials, Positive Energy Boosters, Omega-3 Marine Lipid Oil, B-12 Booster Shot, Cell Power, and Super Silica products were not unapproved new drugs, they would be adulterated dietary supplements based on the violations listed below.
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
- dd40cadcc707
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 →