Tuesday, February 23, 2010

Charles Black not in favor of Senator McCain's proposed Dietary Supplement Safety Act

S.3002 makes changes to the Federal Food, Drug, and Cosmetic Act adding to the overall authority of the FDA by changing definitions to be more inclusive of dietary supplements. It also adds new penalties to old fines of up to 2X gross profits. It does place the burden of proof of the manufacturer or distributor of the dietary ingredient or dietary supplement to prove the safety of their products before being offered to the public and requires registration of DIETARY SUPPLEMENT FACILITIES. The effect on small, local health food stores and vendors of herbs and supplements would be a huge burden, and could cause these businesses to fail.

Though the safety of the public must be maintained, a balance should be found. A list of known safe herbs and other ingredients used in dietary supplements should be excluded from the burden of proof. Also, there should be exclusions of small businesses that use known safe herbs and dietary supplements in normal common ways from having to register with the FDA. An example would be a small organic farm that produces St. Johns Wort, and only supplies a local health food store who makes no claims to the products health benefits.

H.R.3262 authorizes; appropriations to fully enforce and implement the Dietary Supplement Health
and Education Act of 1994. Over a period of 5 years, this would appropriate $195,000,000 to the FDA for enforcement and opens the door to untold amounts of funding as follows, “(2) such sums as may be necessary for each of the fiscal years 2011 through 2014.” This unknown amount of proposed funding is said to be needed for expanded research and development of consumer information on dietary supplements.

If these two bills were to be enacted, it would undoubtedly become an unprecedented move against the dietary supplement industry. It is unclear, at this time, without further investigation, what the current needed balance is between consumer protection and freedom to make individual health decisions. We are always skeptical of a huge increase in federal power and control. These bills, when measured by our standard of, “less taxes, more freedom, less government,” fails all three. In the spirit and language that these bills are written, when elected Charles Black would be unable to favorably vote them in.