Does a company in Covington, Georgia 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 that Covington-based Star Health and Beauty made such claims for a variety of products it sells. Now, the company has some explaining to do to the Food and Drug Administration.
The federal 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 pounds the company for a variety of other violations noted during an inspection of its drug, dietary supplement and cosmetics manufacturing facility. Among the cited problems: Instead of having written instructions for producing products, Dukes tells his staff how to produce them.
And if customers suffer any serious consequences after using a product such as Your Contour Too Breast Enhancing Capsules or NuMan Male Enhancement Capsules, they won’t find any information on the labels about where to report such adverse events. Besides, the company hasn’t established any procedures to handle complaints for any of its drug products, the agency wrote in the recent warning letter.
Dukes was told to correct violations immediately or face the consequences. Among them, the agency could seize any illegal products, the letter says.
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 no longer appears to be active. However, some of the products listed in the warning letter are sold on Amazon and other online sites.
Several Georgia companies have come under federal scrutiny for their dietary supplement products. Among them, a Norcross company is being prosecuted after officials said some of its products were spiked with illegal steroids. Read about it here: http://investigations.blog.ajc.com/2017/05/01/how-a-georgia-product-was-tied-to-rare-case-of-liver-failure/
Another Norcross company has battled the federal government and critics for years. Catch up here: http://investigations.blog.ajc.com/2017/01/19/norcross-company-loses-costly-fight-to-scare-off-harvard-critic/
AJC staff writer Nathan Harris contributed to this report.