FDA targets dietary supplements maker for selling unapproved, misbranded drugs
SILVER SPRING, Md. The Food and Drug Administration on Wednesday announced that Toby McAdam and Greta Armstrong, doing business at Rising Sun Health and The Center for Complementary and Alternative Health of Livingston, Mont., have signed a consent decree that prohibits them from manufacturing and selling unapproved new drugs and adulterated or misbranded dietary supplements in violation of the law.
Prior to entry of the consent decree, Rising Sun manufactured and distributed a variety of unapproved new drugs under such names as Black Salve, Cansema and Can-Support. These products included topical salves purported to treat skin cancer, as well as oils and capsules claimed to be therapies for other serious diseases, such as breast cancer, asthma, anemia and epilepsy. Rising Sun misbranded many of these unapproved new drugs as dietary supplements.
“The FDA will not tolerate unsubstantiated health or disease claims that may mislead customers,” stated Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that consumers do not become victims of false cures.”
Under the consent decree, Rising Sun agreed to stop making and selling unapproved new drugs and products with unauthorized health claims. Rising Sun also agreed to hire an independent expert to review the claims made for future products and to certify that all violative claims have been omitted. The FDA can order Rising Sun to stop manufacturing and distributing any product that fails to comply with the consent decree or the Federal Food, Drug, and Cosmetic Act. The consent decree also provides for damages to be assessed against Rising Sun in the event of such violations.
The consent decree was filed in the U.S. District Court for the District of Montana and is subject to court approval.
Boogies be gone
NEW YORK Little Busy Bodies has brought to the market Achooz, a saline nose wipe aimed at adults, following its success with its for-kids version Boogie Wipes.
The saline solution is ideal for dissolving dried mucus, the company noted. Pictured here on a clip-strip, Little Busy Bodies’ pathway to success may mirror that of Airborne, as the line of kids and adult nasal wipes was developed by two moms.
Cub Foods addresses gluten allergies with diet management program
STILLWATER, Minn. Supervalu’s Cub Foods is looking to help customers with gluten sensitivity with the launch of a new, informative diet management program at its stores located in Minnesota, Illinois and Wisconsin.
Developed by Supervalu’s health-and-wellness team and dietitians, the program will roll out in phases over the next three months. The program will present in-store signage about gluten-free foods in Cub Foods stores — as well as in Supervalu’s family of other stores — and also will feature gluten-free shopping lists and guides. In addition to recipes, more extensive gluten-free shopping lists and snack and meal solutions will be available on the stores’ websites.
The new program builds on Supervalu’s Nutrition iQ program, an in-store nutrition ratings system to help customers identify healthy food choices.
“For people suffering from gluten intolerance, eating foods with gluten causes inflammation and damage to the lining of the small intestine, which can result in nutrients passing through the body without being absorbed. This may contribute to other health concerns, including malnutrition, some types of cancers and a variety of autoimmune diseases,” said Anthony Provenzano, Supervalu pharmacy director of clinical programs. “As a whole, the U.S. population is seeing an uptick in gluten intolerance, and there are many more people who have it — but don’t know it. This program is designed to help people manage a gluten-free diet and hopefully encourage others to seek advice from a healthcare professional about a possible sensitivity to gluten.”