The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

Many people believe that the dietary supplement market needs regulation of the manufacturing process. Dr. Pieter Cohen, a general internist at Cambridge Health Alliance,  and assistant professor of medicine at Harvard Medical School, has a plan for regulating supplements and ensuring that clinicians and other medical practitioners report dangerous supplements in a timely and comprehensive manner. If his plan was implemented we might not be revisiting the topic of dietary supplements like (e.g., OxyElite Pro that has been linked to 47 hospitalizations, three liver transplants and one death).

In an interview for the New England Journal of Medicine Dr.Cohen suggested the following:

  • Accurate information on every supplement sold in this country should be incorporated into databases maintained by both the FDA and poison centers.
  • Key organizations, including the poison centers, the Defense Department, local departments of public health, and manufacturers, would share reports of serious supplement-related adverse events with the FDA.
  • A supplement response team could be created, made up of expert clinicians, toxicologists, pharmacologists, and chemists. The team could be based at the CDC, the FDA, the poison centers, or an academic institution. When consumers or physicians report a serious adverse event, the supplement response team could be alerted and could offer advice on patient care to physicians, provide detailed reports to the FDA, and analyze patients’ unused supplements for labeled and unlabeled ingredients.
  • Supplement manufacturers could be required to provide complete manufacturing details and additional samples as requested. These changes would ensure that the FDA received accurate and timely reports, and clinicians would receive expert clinical advice as they cared for affected patients.”

It is an extensive plan that would require the FDA to change the way supplements are dealt with today. It is a plan that likely would save lives, if Dr. Cohen, and other experts, are believed.  Currently the FDA operates under the Dietary Supplement Health and Education Act of 1994, or DSHEA, which basically says that dietary supplements are assumed safe until proven otherwise. The problem is that by the time an event has occurred and linked to a dietary supplement, serious injury or death may have occurred.  The Act is reactive instead of preventative.  The DSHEA’s lack of regulatory teeth is the reason we have seen an explosion in the number of dietary supplements available today. Reports indicate Americans are spending close to $32 billion every year for unregulated dietary supplements—some, as I noted in an earlier article, containing dangerous substances  – or in many cases, no herbal ingredients at all.

Dr. Cohen feels strongly about the changes that need to be implemented at the Congressional level and in the FDA’s oversight. The legislative issue has been hampered because Senators Hatch and Harkin, the sponsors of DSHEA, have monetary ties to the supplement industry. A new bill being sponsored by Senators Durbin and Blumenthal proposes a partial solution: “The bill, Cohen says, would require supplement makers to register their products with the FDA and provide more safety information to buyers. The supplement industry will be fighting this one tooth and nail, as they have previous efforts to chip away at DSHEA. Just last year, Hatch and Harkin forced the FDA to back down from an effort to tighten regulation of supplements.”

The new legislation proposed by Senators Durbin and Blumenthal would be a step in the right direction.   The DSHEA is nearly impotent.  Until there is real regulatory strength given to the FDA, dangerous products like OxyElite Pro will continue to flood the market and unwary, and even misled, consumers will either get ripped off, at one end of the spectrum, or suffer serious injuries or death at the other.

Comments are closed.

Of Interest