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Posted March 15, 2013

Maker of Liquid Supplements Warned For Manufacturing Violations and Drug Claims

On January 31, 2013, the FDA issued a warning letter to Liquid Health, Inc. following a facility inspection which found the company's dietary supplements, including Attention, Calcium and Magnesium, Diabetic Support, Immune Balance, and Ultra-Antioxidant 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 conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, failure to establish specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement and releasing for distribution dietary supplements that did not meet specifications on their labeling.

Liquid Health also failed to report a Serious Adverse Event Report within 15 days, after a consumer complained that Liquid Health Complete Multivitamin had a different taste and smell from the same previously purchased product. The consumer continued using the product and subsequently developed a bacterial infection requiring antibiotic treatment.

The FDA found the company's written responses regarding these violations to be inadequate.

Additionally, the FDA found statements made about Attention, Calcium and Magnesium, Diabetic Support, Immune Balance, and Ultra-Antioxidant on labels and Liquid Health's website to be drug claims.

Attention contains B vitamins, vitamin C, calcium, magnesium, chromium, choline, a blend of phospholipids and essential fatty acids, gamma-aminobutyric acid, taurine, L-tyrosine, extracts of banana, kiwi, mango, pineapple, cranberry, cherry, raspberry, red pepper, plum, apricot, ginger, broccoli, spinach, kale, cabbage, orange, grapefruit, lemon, lime, green tea, DMAE, red algae, stevia rebaudiana, grape seed extract, L-theanine and pumpkin seed extract.

It was promoted for the treatment of ADHD with statements such as "designed to supply nutrients thought to reduce symptoms of ADD/ADHD."

Calcium and Magnesium contains vitamin D3, calcium, phosphate, magnesium, manganese, boron L-lysine, silica and horsetail extract. It was promoted for bone health, with statements such as "Boron…. Staving off osteoporosis."

(See's Reviews of Vitamin B Supplements, Vitamin C Supplements, Calcium Supplements, Magnesium Supplements, Chromium Supplements and Greens and Whole Foods Powders for tests of related products.)

Diabetic Support contains B vitamins, zinc, magnesium, fenugreek, pancreas substance, Gymnema sylvestre, Momordica charantia extract, biotin, astragalus root, inositol, Korean Panax Ginseng, vitamin D, cinnamon bark, and vitamin E. It was promoted with statements such as "Intended for use by diabetics, or others looking to stabilize blood sugar levels." The name of this product was also found to be a disease claim.

Immune Balance 365 contains vitamin C, vitamin D, vitamin E, ashwagandha root and leaf extract, Maitake fruit body extract, probiotics, elderberry juice, eleuthero leaf extract, stevia leaf extract and Rhodiola rosea root extract. It was promoted with statements such as "365 days resistance from germs & bacteria" and "fights infections."

(See's Reviews of Zinc Supplements, Ginseng Supplements, Vitamin D Supplements, Vitamin E Supplements and Probiotic Supplements for tests of related products.)

Ultra-Antioxidant contains vitamin A, vitamin C, vitamin E, gooseberry fruit extract, selenium, blueberry extract, strawberry extract, cranberry extract, bilberry extract, elderberry extract, raspberry seed extract, Lycium barbarum, rose hips, acai berry extract, resveratrol and CoQ10. It was promoted with statements such as "… provides a benefit by disrupt[ing] … cancer and other diseases."

(See's Reviews of Vitamin A Supplements, Selenium Supplements, Acai Berry Supplements and Beverages, Resveratrol Supplements and CoQ10 Supplements for tests of related products.)

For more information about the FDA's warning letter, use the link below.