There are a few very specific places to look if you want to read the tea leaves of potential reforms by Congress. One is the Oversight committee correspondence with the agency that regulates your area of interest as well as with key stakeholders. Another is to look and see what research key members of Congress ask from the Congressional Research Service. Another is the nature of the investigations and themes of hearings conducted by germane members of Congress. Then there is the testimony provided by the regulatory agency with jurisdiction over your area of inquiry. And finally, there are reports conducted by the U.S. General Accountability Office which can often provide the blue print for future reform legislation through its reports.
The report is responding to the fact that since the mandatory reporting of adverse events went into effect in December 2007, there has been a 3-fold increase in the number of events reported. The report states that in the wake of such reports, the GAO finds that the FDA has a limited amount of knowledge about the industry itself, its products, and has no authority to facilitate to the removal of products that may pose a hazard. When that fact is combined with the fact that Americans take a huge number of dietary supplements ranging from very general multiple vitamins to mysterious potions making arcane health claims, the GAO feels there is a need to change the status quo.
Here are the primary recommendations of the report…
1. To improve the information available to FDA for identifying safety concerns and better enable FDA to meet its responsibility to protect the public health, we recommend that the Secretary of the Department of Health and Human Services direct the Commissioner of FDA to request authority to require dietary supplement companies to
• identify themselves as a dietary supplement company as part of the existing registration requirements and update this information annually,
• provide a list of all dietary supplement products they sell and a copy of the labels and update this information annually, and
• report all adverse events related to dietary supplements.
2. To better enable FDA to meet its responsibility to regulate dietary supplements that contain new dietary ingredients, we recommend that the Secretary of the Department of Health and Human Services direct the Commissioner of FDA to issue guidance to clarify when an ingredient is considered a new dietary ingredient, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing ingredient identity.
3. To help ensure that companies follow the appropriate laws and regulations and to renew a recommendation we made in July 2000, we recommend that the Secretary of the Department of Health and Human Services direct the Commissioner of FDA to provide guidance to industry to clarify when products should be marketed as either dietary supplements or conventional foods formulated with added dietary ingredients.
4. To improve consumer understanding about dietary supplements and better leverage existing resources, we recommend that the Secretary of the Department of Health and Human Services direct the Commissioner of FDA to coordinate with stakeholder groups involved in consumer outreach to (1) identify additional mechanisms—such as the recent WebMD partnership—for educating consumers about the safety, efficacy, and labeling of dietary supplements; (2) implement these mechanisms; and (3) assess their effectiveness.
These recommendations call for a lot of Guidance – which is relatively cheap. But where will the money come from for the monitoring and enforcement? Could there be a VUFA (Vitamin User Fee Act) in our future?