Posted June 10, 2017

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

On May 25, 2017 the FDA issued a warning letter to The Herbalist, Inc., following a facility inspection which found the company's products, including Prostate Choice, Wormwood Capsules, Immuno-Blast, Ache-Less and Kids Be Calm to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

Among these violations, finished product specifications failed to include specifications for strength and composition, as required by federal regulations.

In addition, statements made about these products on labels and the company's website were found to be drug claims.

For example, Prostate Choice was promoted with statements such as "Studies have demonstrated the effectiveness of Saw Palmetto in reducing symptoms such as frequent, painful urination with reduced urine flow...

See ConsumerLab.com's Review of Prostate Supplements for tests of related products.

Immuno-Blast was promoted with statements such as "[P]rovides a blast to the immune system... specific for boosting immunity against colds and flu.

See ConsumerLab.com's Review of Echinacea Supplements for tests of related products.

In addition, several of the company's products were found to be misbranded, because the labels failed to provide required information.

See Related Warnings:

Seller of Herbal Supplements Warned for Manufacturing Violations, Drug Claims

Seller of Vitamin C, Calcium, Mushroom Supplements and More Warned for Manufacturing Violations

Seller of B Vitamins, Vitamin C, Potassium & More Warned for Manufacturing Violations

Maker of Prelief, Urinozinc Prostate Health Formula Warned for Manufacturing Violations

Seller of Mineral, Joint Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of B Vitamins, Omega-3s and More Warned for Manufacturing Violations, Drug Claims

Seller on Noni Juice Warned for Manufacturing Violations, Drug Claims

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