S.3414 Dietary Supplement Full Implementation and Enforcement Act of 2010
Status: Introduced on May 25, 2010
What’s next: The Senate must vote on the bill. No vote has been scheduled.
What it does: The bill gives the Food and Drug Administration additional resources to enforce the Dietary Supplement Health and Education Act of 1994. It requires the FDA to work more closely with the Drug Enforcement Agency when anabolic steroids are found in dietary supplements. It requires the release of New Dietary Ingredient guidance and annual registration for supplement manufacturers, packers and distributors. It provides additional funding for implementation, including $20 million in 2010 and $30 million in 2011, with additional funding thereafter.
Retailer know-how: Industry officials say further funding in the bill will beef up enforcement of industry regulations. “The way to get bad actors out of the industry is by putting more cops on the street,” says Natural Products Association CEO John Gay.
Loren Israelsen, executive director of the United Natural Products Alliance, says the bill “completes the unfinished business of full implementation of DSHEA. The government should be spending the appropriate amount of funding to help consumers use supplements safely and confidently.”
S.510 FDA Food Safety Modernization Act
Status: The Senate bill was amended to exempt dietary supplements. However, the House version, which has been passed, still includes dietary supplements.
What’s next: The Senate has not scheduled a floor vote on the bill. The final bill must reconcile the House and Senate versions, including whether to retain the exemption for supplements.
What it does: The bill provides broad new authority to the Food and Drug Administration to regulate how food is grown and processed. The new language in the bill states, “Nothing in (this) section shall be construed to affect the regulation of dietary supplements.”
Retailer know-how: Many naturals industry officials applauded the amendment excluding supplements from the bill.
The Alliance for Natural Health says the original inclusion of dietary supplements created “a slippery slope toward U.S. harmonization with Codex Alimentarius,” also known as the World Food Code, which provides standards for food safety but which critics say is controlled by the pharmaceutical giants. ANH says it “worked to protect the natural health community from this dangerous provision that threatened access to high quality, therapeutic supplement doses.”
Current Good Manufacturing Practices
Status: As part of the implementation of the Dietary Supplement Health and Education Act, the FDA issued a final rule for current good manufacturing practices for dietary supplements in June 2007 and staggered compliance dates based on number of employees over three years.
What’s next: The final compliance date was June 25, 2010, for companies with fewer than 20 full-time-equivalent employees.
What it does: The rule requires that the proper controls be in place for dietary supplements to ensure their identity, purity, quality, strength and composition during manufacturing, quality control, packaging, labeling and holding,
Retailer know-how: Manufacturers with fewer than 20 employees must train them on CGMPs and to prepare the necessary documentation for inspection. “The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination and with accurate labeling,” said Robert E. Brackett, former director of FDA’s Center for Food Safety and Applied Nutrition, in 2007 when the rule was issued.