Posted June 23, 2017

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

On May 26, 2017 the FDA issued a warning letter to Star Health & Beauty LLC, following a facility inspection which found the company's products, including Nu Essentials Royal Jelly Capsules, NuMan Male Enhancement Capsules, Star's Male Potency Tonic, NuGen HP, She Max HP, and V Max H. 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 for limits on those types of contamination that may adulterate and failure to establish and follow written procedures for the responsibilities of the quality control operations, as required by federal regulations.

In addition, certain statements made about these products were found to be drug claims. For example, NuMan Male Enhancement Capsules was promoted with statements such as "[M]uira Puama is one of the best herbs to use for erectile dysfunction...," Star's Male Potency Tonic was promoted with statements such as "[B]eneficial for prostate enlargement and infections."

See ConsumerLab.com's Reviews of Sexual Enhancement Supplements and Prostate Supplements for tests of related products.

The company also made statements about its topical creams which were found to be drug claims. For example, proEASE Wild Yam Cream was promoted with statements such as "With hot flashes... apply... cream each time they have a hot flash...," and ProPhytogen Cream was promoted with statements such as quot;It has a stabilizing effect on the entire endocrine system, calming hot flashes and night sweats, and restoring normal sleep patterns," and quot;Used to dissolve blood clots, strengthen the central nervous system and nourish the brain."

See ConsumerLab.com's Review of Menopause Supplements, which includes progesterone creams, for tests of related products.

Several of the company's supplements, including Contour Too Breast Enhancing Capsules, ProPhytogen Plus, NuMan Male Enhancement Capsules, Bentonite Magma, Liu Jun Zi Tang, and Clear Spiro were also found to be misbranded, because the labels failed to provide required information, such as complete ingredient lists or others a domestic company address or phone number.

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