By Neil E. Levin, CCN, DANLA via www.honestnutrition.com
1. Some have stated that the dietary supplement industry is largely “unregulated”.
My response: This is not really a fair statement considering that recent regulatory efforts – supported by that same industry – have clamped down on the industry’s freedom to operate outside the regulatory system. Drug and dietary supplement regulation are becoming more and more similar, though the safety records of the two types of products are remarkably distinct. The dietary supplement industry is now largely regulated, with more and more regulations closing the gaps. Indeed, the industry strongly supported the law to ban steroid precursors from being sold as dietary supplements, making all such products illegal drugs. And the 2006 passage of a law to require all serious adverse events to be reported to MedWatch within 3 weeks – now in effect – is an appropriate method of monitoring safety and determining problem areas needing increased monitoring or official action; though we should not confuse raw AERs with actual evidence of causes-and-effects. The implementation of the long-delayed current good manufacturing practices (cGMP) regulations (that were actually authorized by the oft-maligned DSHEA law in 1994) now requires all supplement manufacturers to be cGMP compliant over the next two years, but with the largest manufacturers required to follow that standard no later than this coming June (2008). cGMP regulations are forcing manufacturers to have quality controls on raw materials and finished goods throughout the manufacturing process, including identity and safety testing. The FDA already prohibits all adulterated products, and has in fact used its authority to act against known offenders, as noted by the agency itself.
2. There are claims that “the Institute of Medicine and the Food and Drug Administration have found that supplement health claims are largely unsupported”.
My response: The FDA clearly regulates supplement label claims and requires manufacturers to submit all label claims and maintain proper documentation. The agency apparently does not review this information unless there is a problem; meanwhile making manufacturers submit such information to it while requiring a contradictory label disclaimer that the FDA has not reviewed the claims. I guess that’s what’s called “plausible deniability”. However, the vast majority of responsible manufacturers are careful to present adequate documentation to the FDA, and the cGMP regulations require well-documented justification of all processes, including the writing of label claims. DSHEA requires preapproval of all new dietary supplement ingredients with an eye to proving safety, though manufacturers are allowed to use existing ingredients if they first submit their new label claims to the agency. All new drugs need pre-approval, as do all new supplement ingredients, but drugs are approved for specific uses (though often used for other unapproved “off label” conditions) while supplements are not allowed to make any disease claims, with very few exceptions for FDA-approved health claims. www.cfsan.fda.gov/~dms/supplmnt.html