Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), both supporters of natural health and supplements, plan to introduce new legislation, the Dietary Supplement Full Implementation and Enforcement Act of 2010, within the coming weeks. The bill will fully fund FDA implementation of the Dietary Supplement Health and Education Act (DSHEA), the legislation that governs the regulation of dietary supplements.
At the present time, opponents of dietary supplements and natural health make false claims that supplements are not regulated and therefore unsafe.
We completely disagree. In the first place, federal regulation does not ensure safety. Second, supplement producers are currently regulated by DSHEA, mandated to report adverse events, and required to comply with Good Manufacturing Practice regulations. The Dietary Supplement Full Implementation and Enforcement Act of 2010 is intended to fund all DSHEA regulatory provisions and therefore rebut the argument by supplement opponents that the supplement industry is not really regulated due to a lack of funding.
Will this work as intended? No one can say for sure. It is possible that the FDA will misuse the funds to persecute supplements. On the other hand, this funding means that, for the first time, some FDA employees will see their jobs as being funded by supplements and likely to disappear if supplements disappear. Perhaps that will work to the advantage of natural health. Only time will tell. In the meantime, the bill will effectively rebut those who keep claiming, falsely, that supplements are unregulated.
Important note: the bill is likely to include some provisions drafted by Senator John McCain (R-AZ). McCain might even end up as a bill sponsor. But this does not worry us. One of the two McCain provisions requires the Food and Drug Administration (FDA) to notify the Drug Enforcement Administration (DEA) if a new supplement ( so-called New Dietary Ingredient or NDI) may contain anabolic steroids. This is not an objectionable provision.
The second McCain provision that may be included in the bill will attempt to clarify the New Dietary Ingredient Process. This is the process whereby supplement manufacturers may petition the FDA to sell substances not sold prior to 1994, the year DSHEA passed. This is a very sensitive area for natural health supporters because of the recent tendency of drug companies to try to convert supplements not sold prior to 1994 into exclusive prescription drugs. We are confident that any provision agreed to by Senators Harkin and Hatch will protect natural health and supplements. But we will have to wait for the particular language. We will report back to you as soon as we have more particulars.