Supplement bills call for more healthcare focus, ‘full’ regulation
The legislation, introduced by Rep. Dan Burton of Indiana, was already introduced unsuccessfully in previous sessions of Congress, prompting industry experts to predict that it will again take a back seat to other priorities.
Deductible medical expenses
The Dietary Supplement Tax Fairness Act of 2009, HR 3263, would amend the Internal Revenue Code of 1986 to “provide that amounts paid for foods for special dietary use, dietary supplements, or medical foods shall be treated as medical expenses”.
The legislation, which is a reintroduction of HR 2719 (110th Congress) and HR 2486 (109th Congress), states that these products “have been shown through research and historical use to be a valuable benefit to human health, in particular disease prevention and overall good health”.
The bill also specifies that the inclusion of the products in the deduction for medical expenses would not subject them to regulation as drugs.
The bill can be accessed here.
Full DSHEA implementation
The DSHEA Full Implementation and Enforcement Act of 2009, HR 3262, also introduced by Rep. Burton on July 20, aims to “ensure that the goals of the Dietary Supplement Health and Education Act of 1994 are met”.
Containing similar language to HR 2718 (110th Congress), HR 2485 (109th Congress) and HR 4760 (108th Congress), the bill would authorize appropriations to fully enforce and implement DSHEA.
“The FDA needs adequate resources to appropriately implement and enforce DSHEA. Congress has appropriated additional funds over the last several years beyond those requested in the President’s budget to implement and enforce DSHEA, reaching $9,700,000 in fiscal year 2003,” it states.
“However, according to the FDA, full implementation of DSHEA would require substantial additional resources. The FDA asserts that between $24,000,000 and $65,000,000 per year will be needed to fully implement DSHEA.”
The bill can be accessed here.
Chances of success…?
However, supplement industry experts continue to approach these bills with caution, without being over-hopeful about their chances of success.
In relation to HR 3263, Daniel Fabricant, Ph.D, vice president, Scientific & Regulatory Affairs at the trade group Natural Products Association said:
“As much as we’d like to see the focus on how supplements can be incorporated into the healthcare system and have a cost-savings benefit, with so much of the focus currently on the healthcare reform bills and food safety bills, as well as some discussion on potentially a second stimulus package, it is unfortunate but it would seem that at this time, such a proposal will take somewhat of a back burner position.”
