Dietary Supplements and New Labeling Legislation

In a Press Conference on February 3, 2010 Sen. John McCain announced his intention to introduce a new bill that would amend DSHEA (Dietary Supplement Health Reform Act 1994) requiring manufacturers of Dietary Supplements to register and disclose all ingredients.

In the Press conference McCain was quoted “All we’re saying is, list the ingredients, OK?” “And register so people will know what they’re taking into their bodies. It’s not really outrageous when you think about it.”

Council for Nutrition CEO, Steve Mister, responded “The responsible dietary supplement industry represents the health and wellness interests of more than 150 million Americans who use dietary supplements each year. We have consumers’ health and best interests at heart because we recognize that without our consumers, we would not exist as an industry. “

According to the Bill the definition of “new dietary ingredients.” Would be replaced by “‘Accepted Dietary Ingredients’, to be prepared, published, and maintained by the Secretary.

If the Bill gets passed the  FDA will have authority for mandatory recall as it has now only with medical devices and prescription drugs. The FDA could then determine and act  if there was reasonable that a product marketed and/or sold as a dietary supplement would cause serious, adverse health consequences or death, or is adulterated or misbranded.

Presently the FDA, even with the new CGMP (Good Manufacturing Process) rule to fully roll out in 2010, has no power to enforce or recall a suspected dangerous product or conduct testing on any product for safety and efficacy. Interestingly as more reports of dangerous tainted dietary products hit the news even some manufacturers of Dietary Supplements have an voiced support legislation to ensure the health of the billion dollar supplement Industry by slowing the erosion of trust in the safety of their products.

The bill outlines proposed new changes that include:

• New facility registration requirements to identify all brands, products, and ingredients
• A revised definition of new dietary ingredients (NDIs) that would rely on an FDA-generated positive list of allowed ingredients
• Extension of existing adverse event report (AER) requirements, such that even minor AERs would need to be submitted to FDA annually
• Policing and record maintenance obligations for downstream manufactures and retailers, who will be obliged to obtain written confirmation, from ingredient suppliers or from supplement brand marketers, respectively, of compliance with facility registration and product notification and rules.
• Obligations and authority for FDA with regard to removing products that present the risk of serious adverse health consequences or death, or are adulterated or misbranded