CRN opposes petition to FDA on weight-loss claims
WASHINGTON The Council for Responsible Nutrition stands opposed to the joint citizens petition filed April 17 by the American Dietetic Association, the Obesity Society, Shaping America’s Health and GlaxoSmithKline Consumer Healthcare, which asks the Food and Drug Administration to treat weight-loss claims for dietary supplements as disease claims, the association stated Monday.
“CRN plans to oppose this petition to re-classify weight loss claims as either disease claims or health claims requiring FDA approval,” stated Steve Mister, president and chief executive officer of CRN. “We believe weight loss claims are legitimate and appropriate claims for products in the dietary supplement category, provided these products have substantiation to support the truthfulness of these claims. FDA has made it clear that it considers weight loss claims appropriate and permissible under the Dietary Supplement Health & Education Act—meaning that manufacturers should not have to seek the Agency’s approval before making these claims. Therefore, CRN intends to vigorously defend the industry’s rights in this area.”
Poll shows Advil, Aleve most popular choice to treat back pain
CHICAGO Half of back pain sufferers reach for Advil or Aleve for relief, according to a poll conducted by Spine-health.com that was released Thursday.
The poll, which ran on www.spine-health.com from March to April 2008, asked 899 consumers which over-the-counter pain reliever they prefer for treating back pain or neck pain. The respondents were offered the choice of several brand name OTC pain relievers, and a write-in option.
Ibuprofen in general (Advil, Motrin and Nuprin combined) accounted for 39 percent of the responses. More than 25 percent of the respondents said Advil (ibuprofen) is their first choice for OTC pain relief, while 24 percent selected Aleve (naproxen). Tylenol (acetaminophen) was chosen by 11 percent, and aspirin was selected by 5 percent. “Other” accounted for 15 percent and responses ranged from various prescription drugs to no alternative specified.
“NSAIDs, like ibuprofen, are most often recommended for treating activity-related pain or discomfort—pain that follows sports, housework, shoveling snow, or other exertion—pain related to muscle strain in the low back, and neck stiffness related to muscle, ligament or tendon strains or damage,” stated Dr. Stephen Hochschuler, an orthopedic spine surgeon at Texas Back Institute and a medical advisor for Spine-health.com.
FDA gives Perrigo approval for OTC nicotine gum
ALLEGAN, Mich. Perrigo on Thursday announced that it has received approval from the Food and Drug Administration to market over-the-counter Nicotine Polacrilex Gum USP, 2 mg (base) and 4 mg (base) (Orange, Coated).
The FDA has determined the product to be bioequivalent to the reference listed drug, GlaxoSmithKline’s Nicorette Gum, which is an aid to smoking cessation.
“This approval of orange-flavored, coated nicotine gum extends our leading store brand position,” stated Joe Papa, Perrigo chairman and chief executive officer. “Our expanded range of smoking cessation products also includes coated mint-flavored gum, coated fruit-flavored gum, uncoated gum and lozenges.”
The overall market for OTC nicotine gum and lozenge products is estimated at approximately $750 million annually at all retail outlets, Perrigo reported.