Sunday, March 7, 2010

Take a Look at the FDA Web Site

Today we have news that major companies are receiving warning letters from the FDA questioning the clarity and correctness of health claims on their food labels. Do you want to see the letters the FDA sent?

If you have an interest in matters within the FDA’s jurisdiction, signing up for email alerts is a good idea. The selection of alerts available is well presented on a single page, a long single page, but a single page.

Interested in drug recalls? Subscribe to recall and alert information. Have an allergy to food coloring? Subscribe to color additive news. Or go to the site when you want the original input on a something you have heard about or read.

FoodSafety.gov is another interesting site, it is worth a visit.

The FDA requires Dietary Supplement labels to clearly state that a product is not designed to treat or cure a disease. That’s the rule. Companies can make claims, but have to have the back up on file and be ready to defend their claims. Self policing is infrequently a good idea, but the FDA was pressured to find a way to allow the sale of dietary supplements whilst protecting the consumer and this is the result. The FDA does not have the resources to review every dietary supplement on the market. It has to rely on input from consumers. It is not a bad compromise based on the requirements presented to the FDA.

As in all similar matters, supplement and food producers study the rules and look for ways to present their claims in the best light within the rules, frequently interrupting the regulations as broadly as possible.

Konsyl Original and SennaPrompt are not dietary supplements but Over the Counter, OTC, pharmaceutical products. They do not have the ‘These statements have not been evaluated by the FDA. These Products are not intended to diagnose, treat, cure, or prevent any disease.’ disclosure on the label. The ingredients have been evaluated by the FDA and found to efficacious for the indications as noted on the label. The labeling is, however, closely monitored by the FDA to ensure that it is in accordance with FDA regulations and only statements approved by the FDA can appear on labels for these products.

John Oram