AHPA requests FDA policy on OTC/supplement combos
SILVER SPRING, Md. The American Herbal Products Association earlier this week challenged the launch of Bayer Consumer Care’s Bayer Aspirin with Heart Advantage, an aspirin product combined with 400 mg of the dietary supplement phytosterols, in a letter to the Food and Drug Administration that requested the agency clarify its policy on over-the-counter drug/dietary supplement combination products.
The association referenced a May 30, 2000 letter in which FDA “strongly recommends” firms refrain from marketing similar type products due to “a number of significant health and policy issues.” Bayer Aspirin With Heart Advantage bears both OTC drug and dietary supplement labeling and claims, the APHA charged, and would seem to run contrary to FDA’s 2000 letter.
“Against this background, AHPA is asking for prompt clarification from FDA to avoid confusion among the public and regulated industries as to the agency’s policy,” stated AHPA president Michael McGuffin. “If FDA has not changed its policy, we assume the agency should evaluate Bayer’s product in the same manner it evaluated the OTC drug-dietary supplement combinations cited in these previous warning letters. If, on the other hand, there is a new policy, it appears as if the marketplace may now be open to other OTC drug-dietary supplement products.”
In its letter, AHPA also urges FDA to provide additional information, especially information addressing the reporting of adverse events associated with combination drug-dietary supplement products.
Haggen, Top Food to offer free prenatal vitamins
NEW YORK A Pacific Northwest grocery chain plans to offer prenatal vitamins and fluoride supplements to expectant mothers for free.
Starting Wednesday, any consumer at a Haggen or Top Food store with a subscription can obtain the vitamins, which normally can cost almost $20 per month.
Midwestern big-box chain Meijer began offering a similar program for prenatal vitamins on Sunday, in addition to a program offering free antibiotics that began in October 2006.
Based in Bellingham, Wash., Haggen operates 33 stores throughout Washington and Oregon under the Top Food & Drug, Haggen Food & Pharmacy and Larry’s Market banners.
Children not getting enough vitamin D, study says
NEW YORK A report published in the Archives of Pediatric and Adolescent medicine found that children are not getting enough vitamin D, which can lead to problems later in life.
The study looked at 380 children between the ages of 8 months and 2 years at Children’s Hospital Boston, finding vitamin D deficiency in 40 percent of subjects. The deficiency can cause weakness in the bones and immune system and results from insufficient intake of fortified milk or supplements, as well as being overweight.
The body manufactures vitamin D when sunlight hits the skin; it is also added to many foods. Foods naturally rich in vitamin D include salmon, sardines, cod, shrimp, milk and eggs, according to the George Mateljan Foundation for the World’s Healthiest Foods, with sockeye and Chinook salmon having the highest concentrations.