DSHEA and FDA Activities Reviewed in Senate Subcommittee Hearing

The US Senate Subcommittee on Oversight of Government Management, the Federal Workforce, and the District of Columbia, is to hold hearings yesterday to examine the challenges and successes the U.S. Food and Drug Administration (FDA) has experienced since the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Industry representatives testified as well as Charles Bell, programs director for Consumers Union, the publishers of Consumer Reports.

CRN Council for Responsible Nutrition) President Annette Dickinson, Ph.D. was one of those who testified, and some of the key points made in her testimony include:

DSHEA Did Not Change the Regulatory Status of Dietary Supplements.

"DSHEA established a premarket notification procedure that would be required for new ingredients used in dietary supplements in the future."

"Were it not for two specific products (ephedra and androstenedione) that have been highly controversial over an extended period of time, the dietary supplement industry would be rightly recognized to have as good a safety record and as strong a benefit profile as any other food category."

"It is sometimes said that it took FDA ten years to take definitive action against ephedra, but this is not an accurate description of the process. From the time former Commissioner McClellan took office and decided to resolve this ongoing issue, it took the agency less than 2 years – lightning speed in terms of the regulatory process."

"CRN and the other industry trade associations are supporting Congressional legislation that will place a long list of these ingredients (anabolic steroids and some precursors of anabolic steroids) under the Controlled Substances Act and thus effectively remove them from the dietarysupplement category."

"Legislative proposals currently on the table (for adverse event reporting) tend to exceed requirements applicable to pharmaceuticals and other product categories."

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.