FDA warns Covington supplements company to correct violations

Agency threatens action after tour of Star Health and Beauty.

Does a Covington company have the secret to stimulating sexual energy, reducing wrinkles, spider veins and menopause symptoms, slowing the aging process, enhancing breasts, treating depression, improving sleep, increasing the size of lips, restoring thinning hair and decreasing body fat?

On its website, the federal government says Covington-based Star Health and Beauty made such claims for a variety of products. Now, the company has some explaining to do to the U.S. Food and Drug Administration.

The agency has warned CEO James W. Dukes that the various dietary supplement products appear to be new drugs, since they are not generally recognized as safe and effective if used how the company promotes them.

In a lengthy warning letter, the agency also notes other violations found during an inspection of Star Health and Beauty’s drug, dietary supplement and cosmetics manufacturing facility. Among them: Instead of having written instructions for producing products, Dukes tells his staff how to produce them.

And if customers have problems after using a product such as Your Contour Too Breast Enhancing Capsules or NuMan Male Enhancement Capsules, they won’t find information on the labels about how to report the issues, according to the FDA. The company hasn’t established any procedures to handle product complaints, the agency wrote in the recent warning letter.

The FDA letter told Dukes to correct violations immediately or the agency could take steps including seizure of any illegal products.

Dukes wasn’t available for comment, according to a person who answered the phone at the company on Monday. A response from the company hasn’t been posted on the FDA website.

The company website listed in the warning letter appears to be inactive, but some products listed in the warning letter are sold on Amazon and other online sites.