GAO Urges More FDA Control Over Dietary Supplements

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.

For those interested in dietary supplement reform, yesterday the GAO issued a report entitled "Dietary Supplements:  FDA Should Further Actions to Improve Oversight and Consumer Understanding."  

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?

Comments

[Jere]

How about taxing the companies that are making billions selling snake oil and killing US citizens with their poison. Their largest budget item is advertising. The idea that these companies cannot afford to do proper clinical research to support the outlandish label claims is bunk. Little known fact. People are getting sick and some are dying from taking the garbage that gets dumpted into the market in the US. It is about time. Unfortunately, the government will face the same resistance it faced when trying to take ephedra off the market. It took a high profile death to get Congress to wake up and order the FDA to do something. The lobbiests and the manufacturers will win this battle and more people will be injured and die. The dietary supplement industry is a scam and a travesty.

[handsoffmyhealth]

Jere, you couldn't be more misinformed and outright wrong. The "snake oil" is FDA approved drugs which have killed more people in the last 10 years than all other drugs, legal and illegal over the last 50 years. Ephedra may have killed a few people, under 100, but 1 single antidepressent FDA approved, has killed over 130,000 since first on the market. The drug company involved has a free pass for the deaths, even though censured by Congress, along with the FDA, for perjury in knowingly presenting false testimony to Congress, and misrepresenting the test results and suppressing the negative results. The approval process is unscientific, outright fraudulent and corrupt. The FDA works for drug companies, which earn Billions on drugs that kill, that are not as efficacious as the vitamins they censure and suppress. The real money is made by drug companies; the 100's of millions are spent on advertising by drug companies-direct to consumer advertising-very misleading. Little advertising is done by vitamin and supplement manufacturers and the FDA and drug companies go to great and frequently illegal lengths to prevent marketing of supplements and valid scientific claims for food and supplements. Vitamin and supplement manufacturers have no real lobby; Drug companies have 4 lobbyists per congressman. They pay insurance companies and doctors to prescribe drugs, and for purposes for which those drugs were never tested or approved. Several FDA approved drugs have been pulled from the market because of adverse events, but reluctantly (just not the one that has killed 130,000) Any one advertised drug such as any one of the statins, and antidepressents earns its manufacturer more than the entire vitamin and supplement industry. You were right about one thing-the manufacturers and their lobbyists will win, and have already-the big drug companies.