Reprinted with permission from e-Journal of Age Management Medicine
William J. Stilling, R.Ph, M.S., J.D.
In early February Senator John McCain (R-AZ) announced that he and Senator Byron Dorgan (D-ND) were introducing into the Senate The Dietary Supplement Safety Act of 2010 ("DSSA"). The goal of the legislation is to regulate dietary supplement more strictly. Senator McCain opined that athletes are using dietary supplements to enhance performance and that some athletes have died from dietary supplements. He pointed to the deaths of Steve Becheler, a pitcher for the Baltimore Orioles and Korey Stringer, a player for the Minnesota Vikings, who died from ephedra, as examples of how FDA's lack of authority over dietary supplements has led to deaths. He also cited a GAO report to Congress that stated the FDA lacks information about dietary supplements and that even if the FDA has information that a supplement is unsafe, current law hinders the FDA from taking quick action to protect the public.
If passed in its current form, the DSSA will substantially increase the authority of the FDA over dietary supplements and will greatly increase the regulatory requirements for any entity in the chain of distribution. Some of the major changes that the DSSA proposes are outlined below.
Registration. "[A]ny business or operation engaged in manufacturing, packaging, holding, distributing, labeling, or licensing a dietary supplement for consumption in the United States" must register with the FDA as a "Dietary Supplement Facility." While the DSSA clearly intends to require registration for manufactures, the bill will require virtually anyone in the chain of distribution to be registered. The term "holding" is particularly broad and could include every health food store, grocery store, and physician who buys dietary supplements and "holds" them for any time prior to selling or giving them to individuals for consumption..
Adulteration. Any dietary supplement that is "manufactured, packaged, held, distributed, labeled, or licensed" by an entity that is not registered with the FDA is deemed to be adulterated. New monetary penalties are included in the DSSA for violation of these provisions.
Reporting Requirements. Every Dietary Supplement Facility must provide the FDA with a list of every Dietary Supplement it manufactures, packages, holds, distributes, labels, or licenses. The list must be updated annually.
Requirements for "New" Dietary Ingredient. If a dietary supplement contains a new dietary ingredient, the manufacturer or distributor must provide the FDA with "information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe." There is an exception for new dietary ingredients that have a history of use or other evidence establishing the new ingredient is safe for use as labeled.
Non-Serious Adverse Event Reporting. A Dietary Supplement Facility whose name appears on the label of a dietary supplement must report to the FDA all non-serious adverse events "associated with" the dietary supplement. Current law already requires reporting of serious adverse events.
Mandatory Recall Authority. The FDA would have the authority to issue a "cease distribution and notification order" if there is a "reasonable probability that a dietary supplement . . . would cause serious, adverse health consequences or death, or is adulterated or misbranded."
The DSSA has already generated much support and opposition. If you want to read the text of the DSSA, go to The Library of Congress Thomas at: http://thomas.loc.gov/cgi-bin/query/z?c111:S.3002:. It will be interesting to see how the politics of the legislation play out. Senator Orrin Hatch (R-UT) has been a long-time supporter of the dietary supplement industry and sponsored the Dietary Supplement Health and Education Act of 1994 (DSHEA), which for the first time allowed manufacturers to make health claims (not therapeutic claims) about dietary supplements. Since that time, dietary supplements have been treated as foods, thought it may be more accurate to describe the current dietary supplement regulatory scheme as one that is a hybrid of food and drug regulation. The DSSA will push regulations more toward the drug end of the regulatory spectrum.
This article is for educational purposes only and is not intended to establish an attorney-client relationship between the author and any reader. This article should not be relied on as legal advice. Anyone needing legal advice should engage an attorney.