Durbin-Braun supplement bill stops far short of real reform

Statement of CSPI President Dr. Peter G. Lurie

Legislation introduced today by Senator Richard Durbin and Senator Mike Braun will help the Food and Drug Administration better understand the dietary supplement marketplace by creating a listing database of all marketed supplements. However, although the bill is a definite step forward, it is not enough to address the risks posed by the thousands of dangerous, tainted, and fraudulent supplements currently on the market. The bill itself needs stronger listing requirements, and more comprehensive reforms are needed beyond the scope of this bill.

For decades, some companies have eluded requirements to notify FDA when introducing new dietary ingredients and there has never been a requirement to notify the agency when new products are marketed. As a result, the agency does not know what products are on the market and, therefore, lacks the knowledge necessary to regulate the $40 billion dietary supplement industry.

Unfortunately, the Act’s listing requirements do not ensure that the FDA database will be reasonably up-to-date, reliable, complete, or of maximum use to consumers. The bill needs more specific requirements for when companies need to update their listings so the database will be an accurate snapshot of the dietary supplement marketplace.

The listing database should also provide consumers with access to information about enforcement actions that the FDA may have taken against the product for violating food safety and labeling laws, and a unique identification system so consumers can look up products they are considering buying.

Beyond listing, the agency needs the ability to act on the information in the listings. Comprehensive reforms to the Dietary Supplement Health and Education Act should be enacted, including:

• Closing the loophole that lets dietary supplement companies bypass FDA premarket safety review by self-determining that new dietary ingredients are “Generally Recognized as Safe”;

• Explicitly allowing FDA to ban adulterated and misbranded products that are marketed as dietary supplements, even if they do not technically meet the current definition of a dietary supplement;

• Strengthening the adulteration standard so the FDA can remove unsafe products from the market;

• Requiring that companies report all adverse events instead of just serious adverse events;

• Requiring additional testing and prioritizing inspections for high-risk supplement categories, such as weight-loss, diabetes, and exercise supplements;

• Authorizing FDA to administer civil penalties against individuals and companies for violating safety and labeling laws; and

• Providing the Office of Dietary Supplement and Programs with $10 million in additional funds to improve its oversight and enforcement.