Herbs regulated as drugs?

Michael McGuffin, President of the American Herbal Products Association wrote an interesting counterpoint in response to an editorial in the journal Clinical Pharmacology and Therapeutics (full text for both should be available for all starting in April 08). J.D. Morrow, a pharmacologist from Vanderbilt University, essentially argued that the FDA has had way too little authority under DSHEA, the act passed in 1994 that classes herbal supplements as 'foods' and regulates them as such. His concerns:
. "A major problem with the DSHEA is that the FDA bears the burden of proof if it decides to assert that a supplement is unsafe".
. "Many supplements contain active ingredients with the potential for serious adverse pharmacological effects if administered in excessive—or, in some cases, even recommended—dosages".
. "The sheer amount of usage and number of products available make adequate oversight of dietary supplements extremely difficult and provide the potential for agents with significant toxicity to enter the marketplace".
Well, thankfully, in order to safeguard us from certain doom, the FDA issued its final rule last summer to help address some of these concerns. Indeed, J.D. Morrow was involved in the commission that pushed for the approval of tighter standards. Nevertheless, he continues:
. "These needed regulations have been a long time in coming but are clearly designed to make more uniform the quality of products sold to the American public".
. "Again of concern, however, is the ability of an understaffed and underfunded FDA to enforce these regulations without additional support".
As I have always suspected, the FDA will require an armed enforcement unit! Only then can we ensure adequate product uniformity.
Morrow concludes that "there is little, if any, evidence that most agents are medically efficacious" (really?) and that therefore "enhanced regulation of the dietary supplement industry (...) must be done immediately".

McGuffin provides some needed clarification in the description of the current regulatory framework. Under DSHEA,
. "a statement for a dietary supplement may be made if…the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading".
. "[Starting on] 22 December 2007, all marketers of supplements (and nonprescription drugs) must submit reports of serious adverse events that they receive. The FDA’s role in regulating dietary supplements has thus been expanded significantly".
. "Criticisms of herbal supplements tend to focus on areas in which federal regulatory agencies fail to enforce the current laws. (...) But these are not failures in the law; these are examples of
the need for more active enforcement of existing law".
As for the new GMP (Good Manufacturing Practices) rules in last summer's FDA pronouncement,
. "These regulations are much more extensive than the standard cGMP rules for conventional foods. The FDA acknowledged that some provisions of the new cGMP rule “may be similar to
the existing drug CGMP regulations,” and many sections of this new rule are borrowed directly from the cGMPs for drugs".
. "In addition, the FDA has assigned itself records-inspection powers that greatly exceed its authority in the conventional food sector".
And, McGuffin concludes,
. "An “herbs as drugs” option could only be seriously considered for the United States marketplace if there is also a willingness to allow claims for the use of these products in the treatment, cure, and prevention of disease and if legitimate historical records are accepted to support claims for traditional use".

That is, the 'gold standard' of the double-blind, placebo-controlled trial would need to be altered for substances that have a long, substantiated track record of historical use.

It will be interesting to see what eventually happens in the United States, since the regulation of herbal medicine has been in a virtual state of 'limbo' compared to Europe, Australia, and the rest of the world. If we had a crystal ball, we might be able to see how heightened regulations and 'professionalization' of herbalists and herbal products might affect our ability to practice our art in the future. Oh, but wait -- we have Canada (which works almost as well):
So many of us are afraid we’re going to go out business. Some people plan to go underground, some people plan to go defiant and see if they’re actually willing to put us in jail . . . we are like the weeds and will never be eradicated.

So spoke an unidentified Canadian herbalist in response to the new regulations that govern natural health products (NHPs). Here is a brief summary of the historical context:
"Until recently, NHPs in Canada were regulated as either foods or as drugs, as stipulated by the Food and Drugs Act. A major impetus for the creation of new NHP regulations was widespread concern that the Food and Drug regulations were inappropriate for NHPs (...) A new regulatory framework came into law January 1, 2004, with a transition period of 6-year. NHPs, including herbs, vitamins, minerals, essential fatty acids and homeopathics which are used to prevent, diagnose or treat disease, restore or correct function or maintain or promote health are now classified as drugs at the level of the Food and Drugs Act".

Very much like the progression we're seeing folks like Morrow advocate. For Canadian herbalists, these new regulations are much more difficult and may well force many underground. As American herbalists have oft lamented,
"smaller companies tend to be run by people who are herbalists, and herbs are their life, and they are very fussy about the quality of the herb and the manufacturing of the herb (...) They're going to make it very difficult for small manufacturers to continue to operate. I really think that they’re treating NHPs as if the risks associated with them were equal to the risks associated with drugs".

We need to think deeply about the costs and benefits associated with increased regulation in a framework that relies on conventional approaches to research, manufacturing, and delivery of medicines. All the components of such a network are extremely different in American herbalism (and, in fact, a unified framework is very difficult to pin down). But if we can be flexible and examine the effects of substances based on their historical context, modern research, and current folk wisdom, then perhaps we can learn to alter our entire approach to health care. After all, form follows intention, and as long as we advocate abstracted, culturally disconnected research as the only way to 'truth', we will continue to experience increased costs, side effects, adverse events, and chronic disease.

No comments: