Just before the New Years holiday on Tuesday, December 30, the FDA dropped a bombshell on the media, announcing plans to ban the sale of dietary supplements containing ephedra. FDA said they constitute an "unreasonable risk of illness or injury" to the public. That night all major TV and radio news outlets covered the ban. FDA Commissioner Mark McClellan was interviewed on the PBS News Hour with Jim Lehrer and on Wednesday newspapers ran headlines like "FDA says it will outlaw ephedra" (Austin American-Statesman, running Marc Kaufman’s Washington Post article at the top of page 1).
ABC received calls from USA Today, the Baltimore Sun, Time, the Los Angeles Times, the Fort Worth Star-Telegram and the News Hour (for background information to prepare for the interview with Commissioner McClellan). I also appeared the following Saturday on Joe and Terry Graedon’s People’s Pharmacy on over 100 NPR radio stations and, later, KABC, the anchor station for the ABC radio network in Los Angeles. Industry veteran Loren Israelsen was interviewed on NPR’s All Things Considered and in the New York Times’ article. AHPA President Michael McGuffin was quoted in the Washington Post article and many other papers, plus an interview on NPR’s All Things Considered.
Aside from Commissioner McClellan and HHS Secretary Tommy Thompson, the person who seems to have gotten the most coverage was consumer advocate Sidney Wolfe, MD, of the non-profit group Public Citizen. Dr. Wolfe is a long-time opponent of ephedra who has pushed for its ban for several years. He stated repeatedly that the FDA ban was a bit late, that 3 states have already banned it (CA, IL, NY) as have many sports organizations, the International Olympic Committee, and the military.
What follows are the main points of my comments in the various interviews:
1. The proposed ban demonstrates that FDA does have the authority and power to remove supplements from the market that it (actually HHS) deems unsafe, contrary to previous assertions by FDA officials, some Congresspersons, and others. DSHEA actually gives the FDA added authority to remove unsafe dietary supplements from the market. This new action by FDA supports that reality.
2. This might not have major impact on the entire herbal market because: (a) Ephedra is an outlier insofar as it is not like most of the popular herbal products, which have shown an impressive record of their safety; ephedra’s fairly dramatic activity raises its potential risks, while most other popular herbs are much more gentler acting, thus in general have a higher safety profile. (b) Most companies who formerly sold ephedra have discontinued it in favor of the so-called "ephedra-free" formulations or dropped this category altogether due to concerns about bad PR and/or insurability problems.
3. This may not bode ill for the herb industry, as, hopefully, it will not become a precedent or gateway for the banning of other popular herbs. In fact, this may have a benefit for the industry, as it will remove the shadow that ephedra has cast over the rest of the herbs and possibly lower some of the demands by some in Congress for more laws requiring the stringent (and possibly unreasonable) regulation of the entire herb and supplement industry. It indicates that current laws are adequate when fully enforced.
4. ABC believes that, absent any compelling evidence suggesting significant safety problems, the free market availability of most herbs should be supported. In certain cases, where serious safety concerns suggest their limitation to the general public, these herbs should be available via qualified health practitioners. Regarding retail sale, they should be allowed to be marketed so long as they are made according to proper GMPs, do not contain any synthetic additives or adulterants, are marketed for appropriate purposes, are properly labeled with adequate warnings and risk disclosure, and there are industry- and government-supported education campaigns regarding their potential risks and benefits.
5. I also noted that initially the RAND report, released in February 2003, did not give FDA the scientific basis it probably wanted and needed to move forward with a ban. However, in the intervening months with so much activity in Congress supporting and calling for FDA action, and with 3 states having banned the herb, FDA probably assessed that it had growing political support for such a ban. It probably determined that the fractionated part of the herb industry that was still interested in ephedra was losing political support, and that some leading industry groups probably would not challenge a ban (i.e., so long as FDA’s final regulations present a cogent and substantiated rationale).
6. Further, I said that FDA was probably very confident that it had all the necessary scientific and medical justification that it may need to support its case in an administrative hearing as required by DSHEA, if it were challenged in a lawsuit by a manufacturer or industry group.
Reuters carried an article on Wednesday, December 31, saying that acupuncturists were happy that the ban would exempt licensed practitioners of traditional Chinese medicine, allowing them to continue using ephedra for appropriate conditions in clinical practice. This, of course, makes sense.
Also on December 31, less than a day after the story broke, the AP ran a story on an ephedra "run," citing examples of companies who were experiencing a rush of orders by phone and the Internet. This was highly predictable. There are thousands or possibly millions of people whose experiences with ephedra-based products have been safe and successful.
Where does it go from here? FDA has intimated that it is considering actions on other problematic herbs but has not revealed their identity. USA Today listed some herbs in a sidebar box along with its editorial on January 6; it contained much misleading and erroneous information, most of which the editor told me it received from the FDA. ABC sent a letter that clarified the misinformation, which was published on January 12 (see ABC’s website for the letter,
When we look at the record for most of the popular herbs, their safety record is impressive, if not exemplary. The safety concerns and regulatory saga will no doubt continue and raise questions as to what level of risk our society is willing to accept for dietary supplements – as well as FDA-approved OTC and pharmaceutical drugs – particularly when they are adequately labeled for their potential risks and guidelines for responsible use. Previously, we ran a story on ABC’s new Safety Labeling Program in which we provide manufacturers with peer-reviewed safety data to help ensure that herb labels offer reliable guidance to help ensure responsible use and help to prevent adverse effects.
At press time (January 12) the FDA had not yet published its new rules on ephedra. It is unclear whether any industry group might challenge the ban. Commissioner McClellan has already stated that he believes that FDA has built an adequate case to withstand any challenge. Interesting scenario: If challenged and if an administrative hearing upholds the ban, then ephedra goes. If FDA loses the challenge, then FDA, and its allies in Congress and the medical community, the media, etc. can argue that the law does not allow FDA to protect the public from unsafe supplements, thereby giving impetus to those who want to amend DSHEA, as proposed in some bills now in Congress. Either way, from the standpoint of an ephedra seller, it’s a lose-lose proposition. From the perspective of the entire herb industry, the second scenario, possibly resulting in additional legislation, may be a bigger loss than that of ephedra.
FDA has now shown it has the power to regulate the herb market. It should fully exercise such authority and Congress should support it in doing so, not with more legislation that may create unreasonable burdens, but by ensuring it has adequate resources to do so. Full enforcement of the law, coupled with consumers’ judicious and responsible use of supplements, can have a positive impact on public health.