Posted December 23, 2017

Seller of Meal Replacement, Protein Drinks, Cranberry and More Warned for Manufacturing Violations

On July 6, 2017, the FDA issued a warning letter to Professional Botanicals, Inc., following a facility inspection which found a number of the company's products, including Kidney Support -- Cleanse & Support, Cranberry Complex -- Urinary Immune Support, Thyroid 3 -- Hypo-Thyroid Support, Cell Detox -- Cellular Detox Support, Veo Natural brand Pearl 3.0 Ultimate Meal Drink , Professional Botanicals brand Immu-Guard, Professional Botanicals brand Viral-Aid, Professional Botanicals brand Pressu-Norm and Professional Botanicals brand Mealplex Ultimate Meal Drink products 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 establish specifications for each dietary supplement manufactured for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and failure to identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a disposition decision, as required for federal regulations.

In addition, statements made about some products on the company's website were found to be drug claims. For example, Kidney Support -- Cleanse & Support was promoted with statements such as "... [H]elping to break down kidney and gallstones." Cranberry Complex -- Urinary Immune Support was promoted with statements such as " In addition to helping with urinary problems, cranberry may also help avoid gastrointestinal ulcers. " 

Professional Botanicals brand Immu-Guard, Professional Botanicals brand Viral-Aid and Professional Botanicals brand Pressu-Norm and other products were also found to be misbranded because the labels provided incorrect and/or inadequate information.

See ConsumerLab.com's Reviews of Protein Powders and Drinks and Meal Replacement Powders and Drinks for tests of related products.

Also see the CL Answer about cranberry juice and supplements for more information.

Aller-geez capsules were promoted with statements such as "decongestant," and "natural way to provide relief from occasional itchy nose, watery, eyes, and occasional sneezing." 

For related information, see ConsumerLab.com's answer to the question Which supplements are best for seasonal allergies? >>

See related warnings:

Seller of Supplements for Pain and Allergies Warned for Manufacturing Violations, Drug Claims

Seller of 5-HTP, Chromium, Curcumin and More Warned for Drug Claims

Seller of Muscle Supplements and More Warned for Manufacturing Violations

Creatine Powder Containing DMAA Recalled

FDA Warns Seller of Acai, Garcinia & More for Drug Claims

FDA Warns Dr. Carolyn Dean of Drug Claims Made for Magnesium, Calcium & Other Mineral Supplements

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