President Bush signs adverse events bill into law

By Clarisse Douaud

- Last updated on GMT

Related tags: Dietary supplements, Food and drug administration, Dietary supplement, Orrin hatch

President Bush has signed the Dietary Supplement and
Non-Prescription Drug Consumer Protection Act, thereby setting in
stone legislation which will require manufacturers to notify the
Food and Drug Administration of all serious adverse events for
dietary supplements.

Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was introduced in June 2006 as a means of obliging supplement manufacturers, packers and distributors to notify the Food & Drug Administration (FDA) of any serious adverse events reports (AERs). The bill is applauded by industry associations for its potential to secure more credibility for supplement makers.

The signing represents a victory for industry associations as the President could have exercised his right to veto the bill, even though it recently cleared both the Senate and House of Representatives. It now remains to be seen how supplement companies will implement the new required practices.

Industry associations have advocated the bill as an extra post-market precautionary measure. It requires supplement labels to include a telephone number for the reporting of serious advert events, and obliges supplement companies to pass on these reports to FDA within 15 days.

The bill has been promoted by the industry as a means of securing more credibility for its products by shielding them from critics who say dietary supplements are ineffectively regulated.

"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,"​ said David Taylor, president of the Natural Products Association.

Existing legislation has drawn criticism because it does not require the same pre-market approval for supplements as for prescription drugs. The dietary supplements industry is regulated by DSHEA, the 1994 Dietary Supplements Health and Education Act. This bill would represent the first amendment to DSHEA.

The proposed amendment was introduced in Congress as a bipartisan bill. Republican senator Orrin Hatch from Utah and Democrat senator Tom Harkin from Iowa were behind the bill.

In recent months, trade associations were active in getting constituents to contact their representatives and urge them to back the bill.

Finally, the bill was passed in an eleventh hour scenario. It was the last action voted on by the 109th Congress - coming through just minutes before the House adjourned.

The bill was placed on the suspension calendar, meaning it required a two-thirds majority to pass. The result was 203 in favor, 98 against. The opposition consisted of 94 Republicans and four Democrats.

Industry associations are now faced with the task of educating industry as to how to adopt AERs in their manufacturing and distribution practices.

The United Natural Products Alliance (UNPA), for instance, has scheduled a seminar program on AERs this month in Utah.

NPA also told NutraIngredients-USA in December that it would be contacting new representatives when Congress convenes to educate them about the bill.

Related topics: Regulation

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