By Rachel Stockton (rachels@foodconsumer.org)
Since the FDA acquired Margaret Hamburg as its new chief, the agency has issued a rash of warnings threatening companies marketing bogus and/or dangerous concoctions.
The latest products to come under FDA fire are ointments that, along with other chemicals, are made with ibuprofen. Although ibuprofen has long been approved if taken orally, it has not been cleared to appear in other forms. Six companies have come under scrutiny for selling the gels.
Many times, the promotion of the gel revolves around the fact that ibuprofen, if taken orally, can cause significant stomach problems. Additionally, these products claim that they do not pose the same cardiovascular risks that prolonged ibuprofen ingestion can cause. However, the FDA maintains that there is no verifiable proof of that assertion; no studies have been financed by the agency in an effort to clear the way for this type of product.
The FDA issued letters to all of the companies involved in the infraction; they have two weeks to respond to the FDA allegations, explaining how they've remedied the current violation, and how they will avoid violation in the future. A couple of them have already made the modifications necessary to pacify the agency.
According to the FDA website, not all over-the-counter (OTC) medications get a free pass; those using ibuprofen must complete an application for a new product. Those products that do not require an application process are those that already comply with FDA regulations regarding labeling, formulations, and indications.
Earlier this year, weight loss supplements containing metabolic steroids were taken off the market, as was Zicam Cold after allegations that it permanently damaged the sense of smell. The FDA has also halted marketing of over 100 bogus, swine flu remedies.
Comments