FDA opens up adverse event files for food, supplements, cosmetics

dietary supplements pills probiotics FDA opens up adverse event files for food, supplements, cosmetics More than 25,000 adverse event reports were linked to dietary supplements since 2004, according to a new report by the Food and Drug Administration (FDA).

Last month, the FDA announced that it was publicly releasing adverse event data it had received related to cosmetics and food, including conventional foods and dietary supplements. The adverse events include any negative reaction or complaints experienced after using or consuming a product, including serious illness, severe allergic reactions or other major medical events, as well as issues such as defective packaging or quality problems.

The first report reached back to Jan. 1, 2004, through Sept. 30, 2016, but did not include voluntary reports made by drug manufacturers. That information is expected to be included in the first quarterly update, which will include the last three months of 2016 and is scheduled to be posted by February 2017. The report revealed a total of 56,574 adverse events, with 56,574 associated with food products; 25,412 linked to dietary supplements, and 4,322 tied to cosmetic products.

The FDA said that being more transparent will help the agency and other public health experts monitor trends in adverse event reports that could signal a safety issue that needs addressing.

A similar system is already in place for prescription drugs. Providing more transparency with foods, cosmetics and dietary supplements is another way the FDA hopes to protect consumers. For example, the agency has limited oversight of dietary supplements. The products are not reviewed by the FDA before they are put on the market, opening the door for makers to slip hidden and potentially dangerous drug ingredients in their products.

Currently, the Personal Care Products Safety Act is pending in Congress. The proposed act will require cosmetic makers to report adverse events related to their products within 15 business days of becoming aware of the problem. The law will also give the FDA mandatory recall authority over cosmetics in the event of a safety concern.

Legal experts say that making the adverse event records public will help consumers be more educated about dangerous food, supplements and cosmetics faster, and may mean more personal injury lawsuits against manufacturers of these products.

Source: Law360