Recalls and Warnings

FDA Warns Seller of Alpha Lipoic Acid, Berberine, and More

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If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem.
(Date Posted: 6/30/2020)

On June 18, 2020, the FDA issued a warning letter to Only Natural, Inc. dba Bio Nutrition, Inc. following a review of the company's website, which found statements made about some of the company's products, including Oww-Gout, Bio Nutrition Urilow, Only Natural Alpha Lipoic Acid Plus, Only Natural Berberine 1000, Bio Nutrition Caraway Seed 1,000, Bio Nutrition Pycnogenol, Bio Nutrition Advanced Berberine 1200, and Bio Nutrition California Poppy Seed to be drug claims.

For example, Only Natural Alpha Lipoic Acid Plus was promoted with statements such as "Chromium may support stable blood sugar levels through insulin utilization, which may benefit those with diabetes and hypoglycemia..."

See ConsumerLab.com's Alpha Lipoic Acid Supplements Review for tests of related products.

Only Natural Berberine was promoted with statements such as "Berberine has been traditionally used as a natural defense against yeast, parasites, fungus and bacteria's..."

See ConsumerLab.com's Berberine and Goldenseal Supplements Review for tests of related products.

Also see ConsumerLab.com's Encyclopedia Article on Gout for more information.

In addition, several of the products were found to be misbranded because the labels did not comply with federal regulations. For example, the products Joint Wellness, Blood Pressure Wellness, Cholesterol Wellness, Blood Sugar Wellness, and Curcumin 500 are misbranded because their labels contain information in two languages but do not repeat all of the information in both languages.

See related warnings:

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

Seller of "Cancer Kits," Alpha Lipoic Acid Supplements and More Warned for Drug Claims

FDA Warns Seller of Goldenseal and Parasite Supplements

For more information, use the link below.

Warning Letter: Only Natural, Inc.



For other Recalls and Warnings click HERE.
For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.


 

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