DSHEA Tutorial: Conclusion and Future Actions

DSHEA

By now, it has probably become stunningly obvious to you that the DSHEA law, while protecting our ability to sell and promote our herbs, has also very much restricted our ability to do what we do.

Yin and yang arise together and while we can’t help people find safe and effective solutions to their diseases, we also benefit from this law that reins in the unethical marketers who can fool people into thinking that they’re getting the help they need when they’re really not.

The DSHEA law concerns itself primarily with what shows up in print, whether that is the physical label on the bottle containing the herbs, or any printed matter (physical or virtual) in support of sales of these herbs. I have seen no indication that the FDA or DSHEA cares about what we say in one-to-one encounters with our patients.

This DSHEA law brings up a number of concerns and frustrations for the TCM community. The one organization that I have found that seems to be stepping up to the plate to represent us on a federal level is the American Herbal Products Association.

DSHEA law is enforced by the FDA, however the FTC (Federal Trade Commission) also has a hand in limiting our claims. In particular they are concerned with truthful (based on oodles of rigorous research) statements. Dr. Weil recently said on his website that Huang Qi (Astragalus) boosts the immune system. Numerous studies have shown taking this herb increases white blood cells in the body. This is common knowledge in the herb business. However, the FTC doesn’t accept the studies that currently exist as authoritative. The bar necessary to clear to the FTC’s level of proof is probably out of range for most individual practitioners and until university studies become more prevalent, we’ll have to keep our mouths shut on research that supports these statements. Of course, this doesn’t mean we can’t say these things, but if we include a purchase opportunity on the same page, then we’re making a claim that the FTC cares about.

One more item that hasn’t been addressed elsewhere in this DSHEA feature is the topic of endorsements. The FTC is paying attention to this too, to catch up on this topic, please see the FTC’s final guides governing endorsements and testimonials.

Good luck with your supplement labeling and may all of your claims be compliant and all of your adverse events be tracked down to some other pharmaceutical entity. ;)

Last modified: August 13, 2009  Tags: ,  В·  Posted in: DSHEA