FDA files permanent injunction against ATF Fitness Products
SILVER SPRING, Md. — The Food and Drug Administration last week took legal action against the dietary supplement manufacturer ATF Fitness Products for substituting ingredients and products without noting the changes on the final product labels.
The permanent injunction, filed on behalf of the FDA by the U.S. Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the Federal Food, Drug and Cosmetic Act. Brands include Sci-Fit, Nature’s Science and For Store Only.
"Dietary supplements have a significant role in the public’s health," stated Dara Corrigan, FDA associate commissioner for regulatory affairs. "[Last week’s] injunction reinforces our commitment to ensuring that these supplements meet the [current Good Manufacturing Practices] requirements the law establishes."
The government’s complaint, filed Nov. 23 in the U.S. District Court for the Western District of Pennsylvania, alleged that in addition to "adulterating" and "misbranding" their final products, the manufacturer and its owner failed to report serious adverse events associated with their products.
This is the first time the FDA has taken legal action against a dietary supplement manufacturer of this size for failure to comply with the dietary supplement current Good Manufacturing Practice regulations, the agency stated.
Performance Health introduces Perform Pain Relieving Spray
AKRON, Ohio — Performance Health announced the availability of Perform Pain Relieving Spray, a solution for applying cold therapy to hard-to-reach areas.
“The new spray allows the pain-relieving benefits of Perform to be easily applied to hard-to-reach areas like the middle of your back and lower extremities,” stated Performance Health product manager Jennifer Bloomhuff said. “You can spray at any angle, even upside down," she said. "We’ve learned that there is a very loyal user of the spray format, so retailers [who] offer a spray in their product mix can capture those consumers.”
Perform pain-relieving spray is formulated with menthol as its active ingredient and a blend of botanical extracts and oils including, arnica, eucalyptus, ilex, lavender, lime, camphor, nutmeg, orange, peppermint, pine, thyme and white tea.
Perrigo gains approval for store brand Mucinex
ALLEGAN, Mich. — Perrigo on Monday announced that it received final approval from the Food and Drug Administration for its store-brand version of Mucinex tablets.
Perrigo is still in litigation with Reckitt Benckiser involving the introduction of a private-label Mucinex. "Perrigo is working through the litigation and expects to begin shipping this product in our retail and wholesale customers’ store brand packaging in the second half of our fiscal year," Perrigo chairman and CEO Joseph Papa said.
Mucinex, an expectorant indicated to relieve chest congestion and make coughs more productive, had sales of approximately $146 million through food, drug and mass merchandisers for the last 12 months, as measured by SymphonyIRI Group, Perrigo reported.