Posted September 27, 2016

Seller of B Vitamins, Omega-3s and More Warned for Manufacturing Violations, Drug Claims

On September 15, 2016, the FDA issued a warning letter to Positive Power Nutrition, following a facility inspection which found the company's products, including 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 to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to implement quality control operations to ensure the quality of dietary supplements, as required by federal regulations.

In addition, statements made about the products on labels and in marketing materials were found to be drug claims. For example, High Energy C-Complex was promoted with statement such as "[H]elps the body heal from ...varicose veins".

(See ConsumerLab.com's Review of Vitamin C Supplements for tests of related products).

B-Complex 100 was promoted with statements such as "[P]rotects against cardiovascular disease ... helps reduce blood cholesterol."

(See ConsumerLab.com's Review of B Vitamin Supplements for tests of related products).

Omega 3 Marine Lipid Oil was promoted with statements such as " [H]elps thin blood that is too thick or sticky ... EPA has been clinically proven to improve the health of those with heart disease, asthma, and cholesterol. It also helps with migraines and depression."

(See ConsumerLab.com's Review of Fish Oil and Omega-3 Fatty Acid Supplements for tests of related products.)

See Related Warnings:

Seller on Noni Juice Warned for Manufacturing Violations, Drug Claims

Seller of Whey Protein Warned for Manufacturing Violations, Drug Claims

Seller of Joint Health, Omega-3 Supplements & More Warned for Manufacturing Violations, Drug Claims

Seller of Turmeric, Milk Thistle and More Warned for Manufacturing Violations, Drug Claims

Seller of Aloe, Sexual Enhancement Supplements and More Warned for Manufacturing Violations, Drug Claims

To read the FDA's warning letter, use the link below