Congratulations – Self and Otherwise

This portion of the review of the happenings at Expo West 2007 concerns the anniversary and other issues that surrounded the meetings and the receptions.

To begin, the American Herbal Products Association celebrated its 25^th anniversary on Friday evening (and throughout the weekend.  A couple of words on the significance and then some more on the celebration.  AHPA is a trade association.  Of that there is no doubt.  The development of such an organization is not a simple undertaking and the development of AHPA demonstrates this.  The focus of AHPA has been clear from its inception and the coverage, advocacy and support of botanicals in commerce for the benefit of mankind has long been its charter.  I have had the distinct privilege of watching AHPA grow over the course of the years and have proudly served on several of their committees and their Board of Trustees.  The milestone 25^th anniversary was an event certainly worth celebrating.  There is no clearer voice for advocacy of the use of botanicals that AHPA within this industry.  Other efforts support the advocacy and many of those efforts (the American Herbal Pharmacopoeia being most notable) work with AHPA in a symbiotic fashion.  The challenges that remain are those that exist specifically as applied to AHPA and the advocacy of botanicals generally.

When DSHEA passed in 1994 botanicals were specifically identified as dietary ingredients.  This identification is useful in continuing to market these materials in a form that is readily available for consumers.  The unfortunate part of this (from some folks who deal with botanicals) is that these materials are considered medicines (read this as drugs in the wonderful world of our regulatory scheme) and the requirements out of DSHEA to label them are “inappropriate”.  Well, over 12 years since the passage of DSHEA (nearly half the lifetime of AHPA) nothing has changed regarding the categorization of botanicals.  Some efforts have been put forward but none are likely to come to fruition.  That hasn’t stopped the industry though.  Nor has it stopped some AHPA members.  A good many of the products sold as dietary supplements that contain botanicals are still labeled as drugs.  No, not that they are called drugs (although in quiet circles there are discussions of “herbal medicines”) but the claims affixed to these products render them drugs within the meaning of the law.  Think that’s not correct?  Take a walk around the Expo Hall and see what is being promoted as the benefits of these products both on the label and from the mouths of the individuals selling them.  I am a big believer in these products to be certain.  Many benefits have been documented (admittedly in markets outside the US) and they do have effects that go beyond the realm of claims limitations imposed here.  However, until there is fundamental change in the structure of our law and regulation, we are saddled with the claims structures and substantiation requirements in place.

What we should do, as I’ve said too often before, is approach the overall aspect of conveying to the customer what we truly wish to convey.  Then we must also be prepared to work at reigning in our own activities in the interim.  Two practices we, as an industry, continue to perform are making claims that are wholly inappropriate by extrapolating data or traditional use information.  This does not exist as substantiation nor are the claims within the limits of our regulations.  The other practice and one that still does not receive enough attention is the matter of using other’s data to support claims.  There cannot be a regulatory scheme that would allow the sorts of claims that botanical products would like to make that allows for any version of a plant extract to make a specific claim substantiated by investigation of another extract entity.  Maybe over the next 25 years of AHPA’s existence they can lead the charge to clean the claims act up enough to have regulatory bodies listen to alternatives to the claims structures presently in place.  They do very good work and their efforts (with the constituency involved) could help make that difference.

The second event of note serves as a prelude to the third and (thankfully) final posting in this series coming tomorrow.  The American Botanicals Council held its second American Botanicals Celebration.  They used this gathering as an opportunity to launch the Herbal Legacy campaign.  For some of us who have been in the industry for a good long while the concept of what our legacy will be sits at the front of our thinking.  What we leave behind when we move on is a critical element in defining what our life’s work really means.  More importantly, the legacy we leave serves as the foundation for the future efforts.  This campaign is a signal to those of us with sufficient stature, ability and willingness to look to that future and do something about it.  What will the next generation of participants in this industry or even those who only use the products find?  The importance of this is something we should note well.  This generation, the one who brought DSHEA into reality and who have spurred the growth of the industry have an obligation to that future.  This includes education, regulatory address and most importantly sharing of the knowledge we possess.  This transfer of knowledge is more important even than the transfer of a successful industry.  The message here is that we need to take the time and have the commitment to do these things that will live on and to build the foundation for the future this industry and these products deserve.