ACT NOW To Oppose the Dietary Supplement Safety Act of 2010On February 3, 2010, Sen. John McCain introduced his Dietary Supplement Safety Act of 2010. Below is a discussion of how McCain's bill threatens to dramatically change the dietary supplement industry. In addition, because McCain's bill will fundamentally change the way dietary supplements are regulated and force the removal of supplements from the market that have been consumed safely for decades, we urge you to contact your representatives to oppose this bill.
ACT NOW!!! Click Here to Contact Your Representatives.
MCCAIN'S DIETARY SUPPLEMENT SAFETY ACT THREATENS TO DRAMATICALLY CHANGE THE DIETARY SUPPLEMENT INDUSTRY
On February 3, Senator John McCain (R-AZ) introduced his Dietary Supplement Safety Act of 2010 ("DSSA"), a bipartisan bill co-sponsored by Senator Byron Dorgan (D-ND).
If DSSA becomes law, it will:
- Require the registration of "dietary supplement facilities," which are defined as "any business or operation engaged in manufacturing, packaging, holding, distributing, labeling, or licensing a dietary supplement for consumption in the United States." The registration would contain information sufficient to notify the Secretary of the name and address of each facility at which, and all trade names under which, the dietary supplement registrant does business.
- Amend the definition of "adulterated" to include dietary supplements that are manufactured, packaged, held, distributed, labeled, or licensed by a dietary supplement facility that is not registered.
- Amend the definition of "new dietary ingredient" to mean a dietary ingredient that "is not included on the list of Accepted Dietary Ingredients‟ to be prepared, published, and maintained by the Secretary."
- Amend the definition of "adulterated" as it relates to a dietary supplement that contains a new dietary ingredient. Currently, a dietary supplement which contains a new dietary ingredient is adulterated unless:
- Require persons submitting information in support of use and safety for a dietary supplement that contains a new dietary ingredient to "create and maintain a scientifically reasonable substantiation file relating to the claim that the dietary ingredient or dietary supplement will reasonably be expected to be safe."
- Require dietary supplement manufacturers and retailers to obtain written evidence that their dietary supplements are registered and that the requirements for new dietary ingredients have been satisfied prior to their manufacturing, packaging, holding, distributing, labeling, or licensing the dietary supplements.
- Impose a civil monetary penalty for non-compliance that is not more than twice the gross profits or other proceeds derived from the manufacture, packaging, holding, distribution, labeling, or license of the non-compliant supplement.
- Require event reporting for non-serious adverse events. The bill fails to define what a non-serious adverse event is, making it likely that reporting will be required for everything from a consumer‟s dislike of the product‟s taste to a consumer‟s objection to the color of a label.
- Give the FDA authority to issue a cease distribution and notification order if "there is a reasonable probability that a dietary supplement or a product marketed or sold as a dietary supplement would cause serious, adverse health consequences or death, or is adulterated or misbranded."
This provision is unnecessary since the FDA can already halt the sale of any dietary ingredient that presents a risk of illness or injury, can get an injunction blocking the sale, and can prosecute those responsible. Moreover, under McCain‟s bill, there are no safeguards to prevent an abusive use of this new regulatory power; the FDA Commissioner has unbridled discretion to remove any dietary ingredient from the market on a mere suspicion that it causes harm.
The ingredient remains off the market while the seller is first required to litigate in a hearing before the FDA Commissioner (thus, no separation of functions) before proceeding to a court of law. Thus, a decision to halt distribution can remain in place for years before there is an independent adjudication on the merits.
Because this bill will fundamentally change the way dietary supplements are regulated and force the removal of supplements from the market that have been consumed safely for decades, we urge you to contact your representatives to oppose this bill.
ACT NOW!!! Click Here to contact your representatives.