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Posted August 29, 2017

FDA Warns Seller of Supplements for Allergies, Joint Pain, Bone Health, and More

On August 16, 2017, the FDA issued a warning letter to Total Nutrition, Inc., following a facility inspection which found some of the company's products, including Aller Ease, Inflam Ease, Airway Clear, Osteo-Gest, Green Energy, Arth-Support, "Cold & Flu" products Olive Leaf Extract, Astragalus Root, and Elderberry Sambucus, "Asthma Clear" products Aller Ease and Airway Clear, and "Inflammation & Pain Relief" products Tart Cherry, Tumeric Curcumin, and Napro-Zyn With Tumeric, Bromelain, and Boswellia 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, Aller Ease claims to contain "antihistamines." 

(See's Answer about supplements for seasonal allergies.)

Arth-Support claims to "[contain] ingredients that are key structural components in cartilage and play important roles in the maintenance of joint cartilage where arthritis may be found." 

(See's Review of Supplements for Joint Health for more information about osteoarthritis.)

Osteo-Gest claims to be "a state-of-the-art, bone-building osteoporosis support formula..." 

(See's Review of Vitamin D Supplements for more information about bone health.)

See related warnings: 

FDA Warns Seller of "Quick Slim with pure Hoodia Gardonii" and "Diabalance Herbal Blood Sugar Balance"

Seller of Alpha Lipoic Acid, Cinnamon Supplements and More Warned For Manufacturing Violations

FDA Warns Seller of Menopause, Sexual Enhancement, Prostate Supplements and More For Manufacturing Violations

Seller of Prostate, Immune Supplements & More Warned for Manufacturing Violations

FDA Warns Seller of Probiotic and Omega-3 Supplements for Manufacturing Violations

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