Senator calls for FDA ban on sale of cough-cold medicines for children under six
WASHINGTON Sen. Chris Dodd, D-Conn., senior member of the Senate Committee on Health, Education, Labor, and Pensions and chair of its subcommittee on Children and Families, earlier this week called on the Food and Drug Administration to ban the marketing of children’s cough-cold formulations for children under six even as industry made the announcement they would no longer market use of those medicines to children under four years of age.
“While I’m pleased to see that the drug companies are voluntarily taking some steps to ensure the safety and well being of our children, I am disappointed that the FDA has not followed the recommendations of its own advisory panel,” stated Dodd. “I strongly urge the FDA to take swift action to ensure the safety and efficacy of these products in young children before one more child is given a medicine that may not only be ineffective but could also be harmful.”
In a letter to FDA commissioner Andrew von Eschenbach, Dodd wrote, “Nearly a year has passed since the FDA’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee voted 13 to 9 against the use of over-the-counter cough and cold medications in children ages two to six. Another cold and flu season is right around the corner, yet commonly available medical products continue to be marketed and sold to the parents of young children even though they have not been shown to be effective and experts have raised serious questions about their safety.”
AHPA disputes FDA’s handling of weight-loss supplement assertions as disease claims
SILVER SPRING, Md. The American Herbal Products Association on Wednesday filed a report to the Food and Drug Administration highlighting “serious flaws in the rationale of a Citizen Petition requesting that the FDA treat weight loss claims for dietary supplements as disease claims.”
“The FDA has correctly ruled that claims are allowed for supplements that may have a benefit in assisting normal and overweight persons to lose weight, and that claims for treatment of the disease of obesity are not allowed,” stated AHPA president Michael McGuffin.
“The petitioners’ argument that the FDA was unaware of information presented in their petition when it developed the existing rule is unsupported. It should also be noted that the petition relies to a large degree on data from a consumer survey that had significant flaws in its design, and that has been poorly interpreted by the petitioners,” he added.
GlaxoSmithKline Consumer Healthcare, marketer of non-prescription weight-loss drug alli, filed the petition April 17 along with the American Dietetic Association, the Obesity Society and Shaping America’s Health. The petitioners claim that being overweight, while not a disease in and of itself, is a significant risk factor for other serious diseases. They request that FDA ban dietary supplements from making weight loss claims as structure/function claims under the Dietary Supplement Health and Education Act, and instead require dietary supplement weight loss claims to be limited to FDA-approved health claims.
“If the FDA granted this petition it would contravene Congressional intent and public policy, and would be unconstitutional under the First Amendment,” McGuffin said. “AHPA requests that FDA deny the petition.”
Vitamin Angels hosts annual fundraiser to benefit world hunger
SANTA BARBARA, Calif. Vitamin Angels will host its annual Celebration of Angels fundraiser Oct. 16, at the Harvard Club in Boston, to coincide with the Natural Products Expo East, the organization announced Thursday.
“Vitamin Angels is an intricate part of solving the worldwide hunger problem,” stated founder Howard Schiffer. “This year, with the support of many concerned individuals and companies in the natural product industry we surpassed our goal of reaching 4.5 million children and were able to reach 7 million. … But we can’t stop here. Casting a wider net of awareness will not only elevate Vitamin Angels’ impact but will bring us closer to solving the problem of malnourishment in children under the age of 5.”
Last year, vitamin A was recognized by the United Nations Children’s Fund as one of the key strategies responsible for cutting early childhood deaths to below 10 million per year, a “first” in modern history. Vitamin Angels, is the only nonprofit organization solely dedicated to providing vital nutrition to those in need internationally and domestically.