Quality control is the focus of the latest attacks on DSHEA following the publication of two heavyweight reports that called for the 1994 act to be amended.
Late last year, the Journal of the American Medical Association published a study that found one in five Ayurvedic herbal products in Boston-area stores contained heavy metals. ?The study, yet again, highlights the need for Congress to revisit the way dietary supplements are regulated in the US,? stated JAMA study co-author Dr David Eisenberg. The researchers called for mandatory testing of all imported dietary supplements for toxic heavy metals.
Then in January, the Institute of Medicine called for the amendment of DSHEA so that conventional medicines and alternative medicines have the same standards for clinical effectiveness, and for supplements to have greater quality control, labelling requirements and incentives to conduct research.
The US botanicals industry was appalled at what they saw as misguided potshots, noting that the importation and sale of herbal products containing heavy metals is already illegal under existing Food and Drug Administration laws; that the bioterror law and DSHEA-mandated good manufacturing practices take care of quality-control issues; that recent Federal Trade Commission and FDA crackdowns on scurrilous health claims is cleaning up untoward consumer messages; and that adverse events reporting legislation (which also covers cosmetics and OTCs) are imminent.
?How can anyone propose amendments to a law that they do not understand?? asked Michael McGuffin, president of the American Herbal Products Association. ?DSHEA is a good law that already forbids misleading claims and requires accurate labelling. If FDA does a good job with the imminent GMP rules, the quality control issue will be addressed.?
Loren Israelsen, president of Utah-based LDI Group, said the reports? authors may be good in medicine but suggested they knew nothing about law. ?Look at the safety record of supplements — with or without ephedra it?s remarkably good. Where is the problem that people keep saying needs to be fixed? Where are the reports of illness and death? I don?t see them.?
While others in the industry quickly counter-attacked on the most recent salvos against DSHEA, Israelsen said he?s hoping the next two years will be a time of ?restoration,? with GMPs and investments in quality and science rewarding companies committed to these ideals. He said any new legislation should be ?surgical repairs or additions? such as intellectual property management issues or adverse-events reports. McGuffin said that ?incentivising research? is the single ?worthy conversation? from both reports. But even that may be an impossible hill to climb because patent laws do not work for inherently variable commodity plants.
?The solution is forward-thinking. We need to think how to incorporate supplements into the bigger health care system,? Israelsen said. ?Whether it?s management of quality of life issues, sleep, prostate, menopause, colds and flu, allergies — pick a category and see where we can benefit all stakeholders. We have a tremendous contribution to make.?