FDA issues injunction against Wilderness Family Naturals for efficacy claims
ROCKVILLE, Md. The Food and Drug Administration has issued a permanent injunction against a distributor of dietary supplements, salves and conventional foods, alleging that it made false claims of its products’ ability to treat, cure, mitigate and prevent diseases, the FDA said Tuesday.
The agency alleges that Silver Bay, Minn.-based Wilderness Family Naturals claimed benefits for its products against diseases such as cancer, diabetes, heart disease, arthritis, hyperthyroidism, HIV and AIDS.
The company has signed a consent decree prohibiting it from manufacturing or distributing any products with unapproved claims of benefits against disease. The company has agreed to remove disease claims from its products? labels, labeling and Web sites, as well as references to other Web sites that contain such claims.
“The FDA is acting to product the American public from companies making unapproved disease treatment claims for their products,” FDA acting associate commissioner for regulatory affairs Michael Chappell said in a statement. “Claims made by Wilderness Family might distract consumers from seeking products that have been shown to be safe and effective in treating disease.”
Tylenol Warming Taxis provide free rides around Capitol Hill
WASHINGTON After visiting New York, Boston and Philadelphia, McNeil Consumer Healthcare is relocating its Tylenol Warming Taxis to the nation’s capital this week, and will offer complimentary cab rides within city limits to Washington residents.
The taxis will be positioned outside select CVS/pharmacy locations from noon through 8 p.m. Dec. 15 through Dec. 21.
Research says 500 deaths of children annually tied to cough-cold medicines
ELK GROVE, Ill. Research published Thursday in the American Academy of Pediatrics official journal Pediatrics determined that there is an estimated 500 pediatric deaths a year associated with children’s cold and cough medicine.
“Up until this new research, officials assumed that there were only 3 or 4 deaths a year from these medications,” said Jeffery Chamberlain, co-founder of Honey Don’t Cough, who performed the mathematical extrapolation. “Deaths have been drastically underreported because when a child gets sick and dies, doctors assume that the death was solely related to the illness itself. Typically, no one thinks to check for toxic medications that could have contributed to the death.”
“We have suggested that our state Medicaid program initiate a public education campaign regarding the risks associated with use of OTC cough and cold medicines since poor, publicly insured families may be more likely to give these products to their infants,” said Mary Ellen Rimsza, lead author of the article “Unexpected Infant Deaths Associated With the Use of Cough and Cold Medications,” and chair of the Arizona Child Fatality Review Program.