FDA seizes $2 million in DMAA product
SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent, the agency announced Monday.
“This company has a responsibility to ensure its products are safe for distribution and human consumption,” stated Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “We have taken action to protect consumers and demonstrate our commitment to their safety by keeping these products from entering the distribution system.”
The retail value of the seized products is more than $2 million, the agency estimated.
A complaint filed in the U.S. District Court for the Northern District of Georgia alleged that the products were adulterated according to the Federal Food, Drug, and Cosmetic Act because they contain DMAA, an unapproved food additive that is deemed unsafe under the law.
The FDA is urging consumers not to buy or use supplements containing DMAA, which can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine. Consumers should check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The FDA has warned consumers about the health risks of DMAA on its web site.
On Nov. 12, 2013, U.S. Marshals seized more than 1,500 cases of finished goods and more than 1,200 pounds of in-process/raw material goods from the Hi-Tech Pharmaceuticals facility.
During the FDA’s inspection of Hi-Tech Pharmaceuticals, which began in October, investigators identified 11 products that were labeled as containing DMAA or its chemical equivalent. These products included Black Widow, ECA Xtreme, Fastin, Fastin-XR, Lipodrene, Lipodrene Hardcore, Lipodrene XR, Lipodrene Xtreme, Lipotherm, Stimerex-ES, and Yellow Scorpion. The investigators also observed bulk DMAA raw ingredients at the facility. Prior to the seizure, on Nov. 1, 2013, the FDA issued an administrative detention, temporarily holding the products until they were seized.
Dietary supplements containing DMAA are illegal and the FDA is using all available tools at its disposal to remove these products from the market. In 2012, the FDA issued warning letters to companies notifying them that products containing DMAA need to be taken off the market or reformulated to remove this substance.
PL Developments expands product offering into store brand liquids with Aaron Industries acquisition
WESTBURY, N.Y. — PL Developments on Monday signed a definitive agreement to acquire Aaron Industries, manufacturer and distributor of liquid-dose private-label over-the-counter, pharmaceutical and consumer healthcare products for the retail and packaged goods industry.
Terms of the deal were not disclosed. The agreement is subject to government approval under the Hart-Scott-Rodino Act. It is anticipated the deal will close in late November.
“PL Development’s preeminent position in the solid-dose market segment, combined with Aaron Industries’ strength in liquids and first-aid products, allows us to provide greater product depth and choices for the growing needs of our retail partners and the consumer packaged goods industry," stated Mitch Singer, PL Developments president and CEO.
“This is a rare combination of two industry leaders with complementary product lines that fit perfectly together,” added Evan Singer, EVP corporate development for PL Developments. “Both companies have experienced strong growth in recent years and have become important suppliers to our retail and consumer packaged goods customers," he said. "Now, with an expanded array of products and capabilities, we see PL Developments establishing more meaningful relationships with our clients by offering a broader product selection and by utilizing our best-in-class operations, supply-chain and quality systems to provide our clients with a scalable and efficient solution for their store brands.
The combination of the two companies will create a new force among private-label providers to mass merchandisers, drug stores, club stores, dollar stores, grocery chains, convenience stores, drug wholesalers and the entire consumer packaged goods industries. As a result of the acquisition, PL Developments will supply products to retailers worth more than $1 billion of sales to consumers encompassing more than 3,000 SKUs of solid- and liquid-dose OTC medicines and consumer healthcare products.
Aaron Industries’ operations will be completely integrated into PL Developments, with combined company headquarters in Westbury, N.Y. Its manufacturing and distribution facilities will remain in Clinton, S.C., and Los Angeles.
PL Developments and Aaron Industries serve most of the nation’s largest retailers, including WalMart, Sam’s Club, Costco, Walgreens, CVS/Caremark, Rite Aid, Kroger, Topco, Target, Dollar General and Family Dollar.
CHPA advocates restoring OTC eligibility under flexible spending accounts
WASHINGTON — The Consumer Healthcare Products Association on Friday submitted a letter to U.S. Treasury Secretary Jacob Lew, thanking the Administration for its recent efforts to enhance flexible savings arrangements’ benefits, the association announced. The association is asking the Administration to take a further step and support restoring over-the-counter medicines’ eligibility under tax-preferred accounts including FSAs and health savings accounts.
“We applaud the Administration for its efforts to revisit options that serve in the best interest of consumers meeting their healthcare needs,” Scott Melville, CHPA president and CEO said. “While the recent announcement allowing consumers to roll over as much $500 in their flexible spending arrangements is a step in the right direction, more must be done," he said. “We are calling on Congress and the Administration to lift the restrictions on consumers’ ability to use tax-preferred accounts to purchase OTC medicines that millions rely on for their healthcare needs. Reversing this restriction and restoring eligibility of OTC medicines under FSAs and HSAs is a straightforward step that will assist American families in securing affordable healthcare.”
CHPA supports the bipartisan, bicameral Restoring Access to Medication Act (S. 1647/H.R. 2835) introduced by Sens. Mary Landrieu, D-La., and Pat Roberts, R-Kan., in the Senate and Reps. Lynn Jenkins, R-Kan., and John Barrow, D-Ga., in the House of Representatives. The association’s letter urged the Administration to support this measure.