FDA Issues Warning Letters to Marketers of Unapproved ‘Alternative Hormone Therapies’
One of the most important factors damaging the public’s perception of the pharmaceutical industry, is the persistence of health claims emanating from purveyors of natural supplements. In this recent announcement, FDA is cracking down on 16 of these of these manufacturers…a drop in the bucket.
FDA believes it is limited by law in its ability to regulate certain claims of natural supplements. You will note, for example, that there are no companies being warned against claims of weight loss, increased energy, increased libido, virility, slowed aging, orgasm improvement, penile enlargement or erectile enhancement. Such claims are generally not prosecuted by FDA because they have been determined to fall outside the bounds of health claims. Another factor limiting FDA enforcement of medical claims by supplment manufacturers is FDA’s limited human resources to enforce such actions. FDA simply isn’t adequately equipped to review the large number of advertisements for “natural healing” products.
Allowing supplement manufacturers to make untested health claims harms the public image of the pharmaceutical industry immeasurably. Lacking adequate studies and their attendant efficacy and safety information, the public is unaware that natural remedies might offer no measurable benefits and/or be associated with potentially serious, even fatal, side effects when used according to manufacturer’s suggested (and unregulated) regimens. As a result, the general public has come to believe that “natural product” means safe and probably effective, and “pharmaceutical product” means associated with side effects or outright dangerous with limited effectiveness. Suprisingly to me, the pharmaceutical and biotechnology industries have done nothing of consequence to alter this pervasive perception. It is a major public relations (and public education) failing of industry; one it could correct if it tried. Apparently less easily addressed is FDA’s persistent failure to crack down on unsupported health claims for natural products, the present actions notwithstanding.
