In both cases, the aspirin has been combined with a dietary supplement into a single pill.

Aspirin is often recommended by doctors to treat general aches and pains and in small doses (baby aspirin) as a blood thinner for patients with heart disease.

The two products in question:

• Bayer Aspirin with Heart Advantage (Bayer Heart Advantage)–aspirin combined with phytosterols (a plant-based supplement also known as plant sterols)
• Bayer Women’s Low Dose Aspirin + Calcium (Bayer Women’s)–aspirin combined with calcium

These product formulations are not approved by FDA. The FDA has issued a warning letter to the Bayer Corporation.

Why the Warning?

Bayer has been marketing these products as pain relievers and as treatments for heart disease and osteoporosis. They claim that Bayer Heart Advantage helps in “reducing the risks of heart disease.”

The labeling for Bayer Women’s also claims that the product helps “fight” osteoporosis.

Treatments for heart disease and osteoporosis must be reviewed by government scientists and cannot be sold over the counter.

In addition the FDA has determined that these products have inadequate and misleading directions and warnings. Both products lack adequate directions and warnings for their safe use by consumers.

According to ABC News these results were discovered by the House Energy and Commerce Committee, has been investigating drug advertising and the FDA’s oversight of pharmaceutical manufacturers for over a year.

Sources:

October 28, 2009. FDA Warns Bayer Over Claims on 2 Aspirin Products: Federal Regulators Call Health Claims Unsubstantiated. ABC News.

U.S. Food and Drug Administration. October 28, 2009. FDA Warns Bayer About Two Unapproved Aspirin Products. Consumer Updates.

Image Source: Esra Su. Aspirin. Royalty Free Use.

At issue is the statement “May Contain Traces of Nuts.” Many believe this statement is too ambiguous to prevent deadly reactions. Instead labels should list what they certainly contain. Clearer labels would be helpful for the 12 million Americans living with food allergies.

Under the current system food companies are required by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) to place labels on packaged foods containing most common food allergens, such as milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts and soybeans, or any other ingredient that contains protein derived from one of these foods or food groups.

One popular choice would be for the FDA to have a standard number of descriptions that are clear and concise and require manufacturers to cite statistics to correctly define what “trace amount” means like “one part per million.”

According to The Food Allergy and Anaphylaxis Network there are more than 12 million Americans currently living with food allergies. In addition there are around 30,000 emergency room visits every year triggered by allergic reactions.

Joseph Brownstein et. al. September 16, 2008. FDA to Take a Close Look at Food Labels: Critics Say ‘May Contain’ Labels Don’t Do Enough to Protect People With Allergies. ABCNews.com

May contain nuts. September 16, 2008. JusticeNewsFlash.com

Alice Turner September 16, 2008 FDA Pushes Food Industry to Clarify Allergen Labels. eFluxMedia.