On February 14, 2013, U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), raided the headquarters of Globe All Wellness, LLC, a dietary supplement manufacturer based in Hollywood, Florida. Marshals seized what are alleged to be tainted dietary supplements, believing the products to be unsafe, as they may contain an undisclosed active pharmaceutical ingredient. Marshals noted that several of the products that were seized contain sibutramine hydrochloride (sibutramine), which is the active ingredient in Meridia, an obesity drug. Meridia was pulled from the market in the United States in December of 2010, after clinical trials determined the drug increased the risk of stroke and heart attack in users. You can read the complete press release here.
There have been no illnesses or serious side effects associated Globe All products to date. Rather, the seizure was prompted due to the presence of undisclosed active drug ingredients, improper marketing claims and a continued failure to comply with current Good Manufacturing Practices (cGMPs).
In particular, the FDA’s Press Release also noted that products that have been marketed in the past by Globe All claim to lower cholesterol and blood pressure, among other claims. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), products that are offered for the treatment of diseases or conditions in man are considered to be drugs and regulated accordingly.
In addition, during prior inspections of Globe All in October 2012 and February 2013, the FDA found the Company was distributing dietary supplements that were not being manufactured in accordance with the FDA’s current good manufacturing requirements that are in place for dietary supplements. These rules became effective in June 2008 and apply to all supplement manufacturers, requiring these parties to ensure that their products are properly labeled and free from contamination, among other things. These regulations also mandate that dietary supplement manufacturers keep certain records in relation to the manufacturing process and conditions thereof. More information about cGMPs for dietary supplements may be accessed here.
In sum, there were a number of issues with the manufacturing and labeling of the products prior to the seizure in the present case. Because various enforcement measures are often taken prior to conducting a seizure, it is important to understand how compliance with the laws and regulations enforced by the FDA can help a company avoid being further targeted by the government.
If you have questions about FDA regulations regarding the manufacturing, distribution and marketing of dietary supplements, please contact us at contact@sglawfl.com.
