Posted September 13, 2013

Metagenics Warned For Misbranding of Medical Foods and Drug Claims

On August 13, 2013, the FDA issued a warning letter to Metagenics, Inc., following a review of the company’s website, which found UltraClear, UltraClear Plus, UltraClear Plus pH, UltraClear RENEW, GI Sustain, UltraMeal Plus, UltraMeal Plus 360, UltraInflamX, UltraInflamX Plus 360, UltraGlycemX, GlycemX 360, Ultracare for Kids, BariatrX Essentials Bariatric Meal, and ArginCor to be improperly promoted as medical foods. The FDA found that these products do not meet federal regulations for medical foods because the conditions for which they are promoted do not have "distinctive nutritional requirements" that "cannot be met through dietary modification alone."

In addition, claims made about these products on Metagenic's website were found to be drug claims.

UltraClear, UltraClear Plus, UltraClear Plus pH were promoted for patients with chronic fatigue syndrome. UltraClear was promoted with statements such as "specialized nutritional support to address... liver detoxification function in patients with chronic fatigue syndrome."

UltraClear RENEW was promoted for patients with fibromyalgia with statements such as "nutritional support to help address altered pain signaling and neuromuscular function in patients with fibromyalgia."

GI Sustain was promoted for patients with leaky gut syndrome with statements such as "specialized nutritional support... for patients with leaky gut syndrome."

UltraMeal Plus and UltraMeal Plus 360 were promoted for patients with metabolic syndrome and cardiovascular disease with statements such as "formulated to nutritionally support the management of conditions associated with metabolic syndrome and cardiovascular diseases including hypercholesterolemia, hypertriglyceridemia, and hypertension."

UltraInflamX and UltraInflamX Plus 360 were promoted for inflammatory bowel disease with statements such as "specialized nutritional support for patients with inflammatory bowel conditions, such as ulcerative colitis and Crohn’s disease."

UltraGlycemX and GlycemX 360 were promoted for patients with type 2 diabetes. UltraGlycemX was promoted with statements such as "food formulated to meet the specialized nutritional needs of patients with type 2 diabetes, insulin resistance, and hypoglycemia."

Ultracare for Kids was promoted for patients with czema, rhinitis, and allergy-responsive asthma, with statements such as "High Quality Nutritional Support for Children with Atopic Disorders."

BariatrX Essentials Bariatric Meal was promoted for pre and post operative bariatric surgery patients.

ArginCor was promoted for patients with peripheral artery disease (PAD) with statements such as "formulated to provide specialized nutritional support for patients with peripheral artery disease."

On September 10, Metagenics issued a response to the FDA’s warning letter.

(See ConsumerLab.com's Reviews of Huperzine A Supplements, Protein Powders and Drinks, Multivitamin and Multimineral Supplements,CoQ10 and Ubiquinol Supplements, Menopause Supplements, Probiotic Supplements, Vitamin D Supplements and Fish Oil Supplements for tests of other Metagenics products.)

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