Posted April 18, 2013

Cardio, Energy and Sexual Enhancement Supplement Distributor Warned For Manufacturing Violations and Drug Claims

On December 21, 2012, the FDA issued a warning letter to ForMor Inc, dba ForMor International, following a facility inspection which found the company’s Cardio Cocktail and Argenix dietary supplements to be adulterated because because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMPs) requirements for dietary supplements.

These violations include failure to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding, failure to establish specifications for labels and failure to perform quality control operations for labeling operations.

The FDA stated that although ForMor hired another company to label these supplements, ForMor is ultimately responsible for ensuring compliance with CGMPs.

The agency also found statements made about Calm Cocktail on the company’s website to be drug claims. For example, the website summarizes a study on melatonin, which was an ingredient in Calm Cocktail, as “A study from the Agency for Healthcare Research and Quality stated that Melatonin decreased sleep onset latency in people with a primary sleep disorder.”

In addition, Calm Cocktail was found to be misbranded because the label did not provide adequate directions for use.

Cardio Cocktail contains L-arginine, L-citrulline, magnesium, pantothenic acid, omega-3, 6 and 9, potassium, vitamin A, vitamin B2, vitamin B6, vitamin B12, vitamin C, niacin, zinc, grape seed extract and skins, and juices of grape, apple, cranberry, red delicious apple, goji, mangosteen, acai, red raspberry and tart cherry. Currently, the label does not list melatonin as an ingredient. It was promoted to improve immune function, cardiovascular health, energy and sexual performance.

Argenix contains L-arginine, vitamin D, white grape juice concentrate, concord grape juice concentrate, aloe vera extract, MSM, phenylalanine, and white willow bark extract, L-citrulline, grape skin extract, quercetin, hawthorn berry nopal cactus juice, mango concentrate, coconut, and papaya. It was promoted to improve immune function, cardiovascular health, energy and sexual performance.

See ConsumerLab.com’s Reviews of L-Arginine Supplements, B Vitamin Supplements and Energy Drinks, Sexual Enhancer Supplements, Fish Oil and Omega-3 Fatty Acid Supplements, Vitamin A Supplements, Vitamin C Supplements, Acai Berry Supplements and Beverages and Coconut Waters for tests of related products. To read the FDA’s warning letter, use the link below.