Cosmeceuticals, Dietary Supplements Makers Will Report Serious Side Effects

Makers of cosmeceuticals, dietary supplements will have to report within 15 business days of any serious adverse event associated with their products.

Makers of dietary supplements, including cosmeceuticals, and over-the-counter (OTC) drugs in the US will soon be required to notify the country’s Food and Drug Administration (FDA) of all adverse effects.

According to the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a bill signed into law by US President George W Bush on December 22, will require manufacturers, packers and distributors of OTC drugs or dietary supplements in the US to inform the FDA within 15 business days of any reports of a serious adverse event associated with their products.

“Nearly 60% of Americans regularly use dietary supplements to maintain or improve their healthy lifestyles,” US Senator Orrin Hatch, one of the authors of the bill, said in a statement, as quoted by Cosmeticnews.com.

The passing of the bill was applauded by industry players. “Our top priority is providing the products that people want to lead healthier, more fulfilling lives,” Natural Products Association president David Taylor said in a statement. “So we welcome and support reasonable legislation like this because it will help consumers and the public understand what we have known for some time, that our industry is made up of good people who make good products and stand by them.”

The new law, set to take effect in December 2007, amends the previous Dietary Supplement Health and Education Act of 1994.