Fight for Healthy Policies

What is DSHEA?

In 1994, Congress took an important step forward with passage of the Dietary Supplement Health and Education Act (DSHEA) - federal legislation that requires manufacturers of all dietary supplements to ensure the products they put on the market are safe. The law holds manufacturers directly accountable for product safety and demands truth in labeling and advertising. This legislative safeguard came under attack by some members of Congress and key regulators in the last session of Congress. And although restrictive legislation concerning dietary supplements was not passed, new bills that are just as bad are expected this year.

Why Undermine Good Public Policy?

There is a common misconception among lawmakers and the media that dietary supplements are unregulated. In reality, good laws exist on the books and need to be enforced by the FDA. DSHEA gives the government agency enforcement power to remove dietary supplements from the market at any time it believes a product is unsafe. And, DSHEA already requires manufacturers of dietary supplements to notify the FDA and provide scientific proof before releasing a product containing a new ingredient.

While the safety record for dietary supplements far surpasses many drug products and conventional foods, some in Congress want to impose standards that exceed those for over-the-counter and prescription drugs. These legislative hurdles could cause vitamins, minerals, herbs, and other products consumers now enjoy to disappear from store shelves or become unaffordable.

What Legislation is Congress Considering?

Congress is now considering legislation that would take away your access to safe, effective and affordable dietary supplements.
 
Both the Senate and the House are considering S. 762 and H.R. 1249, a bill to include dehydroepiandrosterone or DHEA, as an anabolic steroid. This legislation would add DHEA to the list of controlled substances, causing it to be immediately removed from the market when the bill becomes law.

DHEA is not an anabolic steroid. It is a naturally occurring hormone that has a wide range of benefits, including maintaining muscle strength and strong bones, boosting immunity, and improving mood and sleep patterns. Further studies suggest that DHEA may be helpful for such conditions as obesity, cancer and Alzheimer's disease. DHEA dietary supplements, which have been on the market for over 20 years, are derived from a plant in the wild yam family.

Congress is also considering legislation that would make dietary supplements more accessible:

The Dietary Supplement and Healthy Meal Replacement Tax Parity Act, H.R. 1107. Under this act, foods and dietary supplements with approved health claims can receive the same tax treatment as other products that maintain health and prevent illness.

The Food Stamp Vitamin and Mineral Improvement Act, S. 770, would give needy recipients the choice of purchasing vitamin and mineral supplements with their food stamps, in the same way they are able to make other dietary choices. If food stamps can purchase junk food, soda, and other goods of minimal nutritional value, food stamps recipients should be able to purchase something that will actually benefit their health: vitamin and mineral dietary supplements.

News on the upcoming CAM draft guidance

The Coalition to Preserve DSHEA has recently heard from concerned citizens about a draft “guidance” document from the Food and Drug Administration (FDA) on complementary and alternative medicine (CAM) that some are claiming will, among other things, classify all dietary supplements as drugs and restrict the practice of CAM therapies. This is not an accurate representation of the facts.

While the Coalition recognizes that the guidance document itself does not affect the practices or products used in CAM, it does represent the FDA’s current viewpoint about CAM, and in that regard, could be clearer. The deadline for comment was April 30, 2007. Regardless of whether this document is finalized or not, this guidance will not change any existing practice under DSHEA.

To view a copy of the guidance, go to: www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf.

Guidance Draft FAQs

• How is a “guidance” different from a regulation or a law?
  
  
• Isn’t it true that all dietary supplements will be regulated as drugs if this guidance is finalized? For instance, the guidance says that claiming cranberry tablets “maintain the health of the urinary tract” is OK, but if you say that the same tablets “prevent urinary tract infections,” then they become regulated as drugs. Doesn’t this mean that all dietary supplements must now be treated like drugs?
  
  
• Even if dietary supplements are protected, what about practitioners? Aren’t they threatened?
  
  
• Can’t this document set a precedent for future legislation that restricts CAM products and practices?
  
  
• Couldn’t those in Congress opposed to practices or products used in CAM use this document in support of stricter legislation?
  
  
• What would motivate the FDA to issue such a guidance?
  
  
• There’s a part in the guidance that says a “drug” is any product that can “affect the structure or any function of the body of man”? Since dietary supplements make “structure/function” claims, doesn’t this mean they’re now considered drugs?
  
  
• Why isn’t the Coalition asking its members to write to Congress, like many other organizations are?

What Can You Do to Save Our Supplements?

Congress needs to hear from consumers that they want lawmakers to protect access to safe, effective and affordable dietary supplements. Tell them to enforce DSHEA and trust consumers with their own health decisions. Although bad bills from the last Congress were not carried over into the current session and have effectively "died," there is every indication that new bills that are every bit as bad are on the way.

Join the Fight

Become a voice for supplement choice and help ensure all Americans continue to have access to the dietary supplements they depend on for good health.

Tell Congress to Save Our Supplements and keep the consumer protections in DSHEA intact.