This year could see the most significant changes to the liberal US dietary supplements model in a decade, following implementation of the Bioterrorism Act in December and the instigation of several bills now working their way through Congress.
The changes are being promoted as a way of dealing with food and supplements safety, but not all are seen as favourable.
"2004 could be the biggest year that we have seen for as long as we've been in this business," said Loren Israelsen, president of consultancy LDI Group in Utah. "We may see the end of the DSHEA as we know it. That would be an enormously contentious issue for an industry that will be highly divided on what we need to do."
The Bioterrorism Act in particular has already eroded some landmark components of the 1994 Dietary Supplements Health and Education Act (DSHEA).
The act requires, among other things, that all facilities worldwide that do business with the US must register their plants with the US Food and Drug Administration (FDA). An estimated 400,000 facilities must comply—"and 398,000 don"t know it," said Israelsen. "This could really disrupt the supply side, with botanicals coming in from overseas."
The act also requires companies to give the FDA access to their records, something specifically denied by DSHEA. "Now we're finding that DSHEA isn't there anymore," said Israelsen.
The fact that some key components of DSHEA have already been usurped is a major focus for advocacy groups including the American Health Products Association and Citizens for Health. These groups lobbied and marched on Washington in October and are gearing up to "save DSHEA."
Other legislation looms
Other attempts to change the regulatory climate are also moving forward.
Two positive changes for the industry were amendments written into the $79.7 billion agriculture spending bill for 2004. One adds $1 million to the FDA budget to fully implement and enforce DSHEA. The second amendment would provide the FDA with an additional $250,000 to address the ephedra issue. "There has been too much talk that the law handcuffs FDA and too little effort to apply the law," said Senator Orrin Hatch, who pushed the amendment. He urged FDA to decide on ephedra's safety "based on the best available science, not politics."
Another bill, S. 722, is being touted as one that regulates ephedra, but it groups all stimulants, such as synephrine, green tea and yohimbe into that stimulant group. These would be scrutinised at a level that, opponents say, would put many of these ingredients suppliers out of business.
Significantly, the bill would exempt the most popular stimulant—caffeine.
Another proposed bill, HR 3377, would require dietary supplements manufacturers to provide an updated list of all products and ingredients every six months to the secretary of Health and Human Services. It would also require reporting and record-keeping of adverse event reports within 15 days. Critics say some of these requirements exceed even those for pharmaceutical drugs.