As we previously reported, on May 16, 2014, representatives from the U.S. Marshals Service had seized more than $11 million worth of unapproved drugs held by Masters Pharmaceuticals of Ohio and marketed by Ascend Laboratories of New Jersey. The U.S. Marshals seized urea cream 39%, hydrocortisone acetate suppositories 25 mg, urea cream 40%, pramoxine-HC otic drops, and urea lotion 40%. The FDA and U.S. Attorney for the Southern District of Ohio requested the seizure because the drugs were not marketed in accordance with FDA regulations, in that they were marketed for conditions that caused them to be deemed drugs but the Company had not secured the necessary FDA approval for the products.

The pramoxine-HC drops were intended to control itching and treat external ear infections caused by bacteria. Ascend Laboratories allegedly marketed the hydrocortisone acetate suppositories for the relief of symptoms caused by ulcerative colitis, inflamed hemorrhoids, and other inflammatory conditions. All three urea-containing products were intended to treat dermatitis, eczema, and other conditions that cause thickening of the skin.

Because none of these products have been proven safe or effective for their intended uses, i.e., obtained FDA approval for the treatment of these diseases and/or conditions, the FDA filed a Complaint alleging that the drugs were misbranded under the Federal Food, Drug, and Cosmetic Act. The complaint came approximately six months after an inspection revealed Ascend Laboratories was allegedly marketing certain products for the treatment of diseases and/or conditions without obtaining FDA approval.

The FDA’s announcement of this seizure explains that these drugs were seized under the Marketed Unapproved Drugs Compliance Policy Guide, which states that any unapproved new drug first marketed after September 19, 2011 is subject to immediate enforcement action even if the marketer never received a prior warning from the FDA. The FDA Compliance Policy Guide for unapproved marketed drugs lists several enforcement priorities. The first two priorities are drugs with potential safety risks and drugs that lack evidence of effectiveness. The FDA is also taking enforcement action against the marketers of so-called health fraud drugs. These products are represented as effective for diagnosing, preventing, curing, or treating diseases, but they have not been scientifically proven safe or effective for their intended purposes.

Drug manufacturers and marketers are subject to close scrutiny under the FDA’s guidelines. The agency has the right to seize drugs and other medical products without any prior warning, putting businesses in this industry at risk for serious losses. If you have any questions about FDA approval or you need help responding to a complaint filed by the FDA, contact us at contact@sglawfl.com.

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.