Industry organizations join forces to dispute new FDA restrictions
COLORADO SPRINGS, Colo. Several organizations representing retailers and consumer healthcare product manufacturers want Congress to reverse a provision in the healthcare-reform act that would prohibit the use of flexible spending accounts to purchase over-the-counter medicines without a prescription.
The provision, part of the Patient Protection and Affordable Care Act, which President Obama signed into law in March, goes into effect Jan. 1. Organizations opposing the provision include the Global Market Development Center, a trade association representing suppliers, retailers and wholesalers of general merchandise, health, beauty and wellness products, as well as the National Association of Chain Drug Stores, the Consumer Healthcare Products Association and the National Grocers Association.
“The new FDA restrictions will add additional confusion [and] expense, and eliminate a benefit many consumers have come to depend upon to cost-effectively purchase medicines they need,” GMDC president and CEO Dave McConnell said in a statement. “Consumers depend on OTC medicines as a first line of defense for their families’ healthcare needs, and retail stores are in the business of providing remedies in an accessible, consumer-friendly way.”
Iatrical to roll out Sippy Sure
NEW YORK Iatrical Innovations soon will launch a product designed to make giving medicine to toddlers easier.
Iatrical announced Monday the upcoming launch of Sippy Sure, a medication-dispensing sippy cup, originally invented by a doctor and father of two small children.
The cup keeps the medicine and drink separate, but mixes them as the child drinks, thus concealing the medicine.
Sippy Sure cups retail for $8.99.
FDA issues warning over use of dietary supplements containing sildenafil
SILVER SPRING, Md. — The Food and Drug Administration on Friday reported that Vigor-25, a product inappropriately marketed as a natural dietary supplement to enhance male sexual performance, should not be purchased or used because it contains sildenafil, the active ingredient in the prescription drug Viagra.
“This product is dangerous to consumers because it claims to contain only natural ingredients when it actually contains a prescription drug ingredient,” stated Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Tainted products place consumers at risk of injury and death, especially those consumers with underlying health conditions.”
Vigor-25, distributed by Piston, is sold on Internet sites and possibly in some retail outlets, the FDA reported.
Sildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and can dangerously lower blood pressure. The FDA is investigating the reported death of a 26-year-old man, possibly associated with the use of Vigor-25.
The FDA has found many products marketed as dietary supplements for sexual enhancement during the past several years that can be harmful because they contain active ingredients in FDA-approved drugs or variations of these ingredients. Sexual-enhancement products promising rapid effects (e.g., claim to work in minutes to hours) or long-lasting effects (e.g., claim to last 24 to 72 hours) likely contain a contaminant, the FDA stated.