FDA has feds seize goods from FulLife Natural Options
ROCKVILLE, Md. At the request of the Food and Drug Administration, U.S. Marshals last week seized approximately $71,000 of goods from FulLife Natural Options, of Boca Raton, Fla., which marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea.
Although these products are labeled as dietary supplements, they are being promoted by FulLife for use in treating serious conditions, such as diabetes, anemia and hypertension, the FDA stated. These claims were evident in the products’ labeling, including promotional literature and FulLife’s internet web site.
The U.S. Attorney’s Office for the Southern District of Florida charged the company for distributing products that are in violation of the drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act.
Following an investigation of the firm’s marketing practices, FDA officials advised FulLife that the claims related to prevention or treatment of diseases made these products subject to regulation as drugs. Despite FDA’s warnings, the firm failed to bring its marketing into compliance with the law. During subsequent inspections, FDA inspectors found that the offending claims were still being made.
The seizure last week at FulLife is the second such enforcement action in two months taken by FDA against dietary supplements being promoted with drug claims to cure or treat diabetes and other diseases or conditions. The FDA seized an estimated $41,000 worth of inventory of Glucobetic, Neuro-betic, Ocu-Comp, Atri-Oxi, Super-Flex, MSM-1000 and Atri-E-400 capsules being promoted and distributed by Charron Nutrition of Tallahassee, Fla., for use in treating diabetes, arthritis, and other serious health conditions in August.
Natrol creates mini-show to introduce its health-focused products for the holidays
CHATSWORTH, Calif. If the holidays stress you out, then you maybe at risk weight gain as well as unhealthy mind. Natrol is trying to combat this with showcases of its products that can combat this problem of staying healthy over the holidays.
Natrol has created “The Balancing Act,” a four-minute segment produced by Five Star Productions and features Natrol products like: Carb Intercept, 5-HTP, Melatonin Time Release and My Favorite Multiple Original Multivitamin.
The segment, which aired on the Healthy Living Channel—on Comcast, Time Warner and Dish Network—on Thursday, Oct. 11, has been posted on Natrol’s web site, www.Natrol.com, as well as on Five Star’s website.
McNeil running ads on product withdrawal
FORT WASHINGTON, Pa. As part of its voluntary recall of several nonprescription products marketed toward infant use, McNeil Consumer Healthcare is today running an advertisement in several consumer daily newspapers.
“The cough-and-cold season is here, and we have important information to share about infants’ and children’s cough-and-cold medicines,” the ad starts, noting that while the medicines are generally recognized as safe and effective when used as directed, “we have become aware of rare instances of misuse leading to accidental overdose, especially in children under the age of 2.”
“This voluntary action by McNeil Consumer Healthcare is based on the company’s long-standing commitment to the appropriate use of medications by parents and physicians,” stated Ashley McEvoy, president of McNeil Consumer Healthcare early Thursday morning. “McNeil Consumer Healthcare is committed to providing parents with safe and effective over-the-counter medications that treat their child’s cough-and-cold symptoms. In addition to taking this voluntary action, McNeil Consumer Healthcare, along with our industry partners, supports the Consumer Healthcare Products Association recommendations that were recently submitted to the Food and Drug Administration. These recommendations include label changes to OTC cough-and-cold medicines advising ‘do not use’ in children under 2 years of age. Our voluntary action in removing [these] products from the market is consistent with these recommendations.”