Alarmed by what it sees as a failure by the Food and Drug Administration to oversee the dietary supplements industry, a task force for the state of New York has recommended that the state begin providing its own supervision.
The New York State Task Force on Life and the Law has urged the creation of a committee, under the authority of the State Health Department, to examine supplements on the market and evaluate their safety and efficacy. Specifically, it urges the state to grant the health department the power to ban certain products, and in specific to consider banning aristolochic acid, comfrey and kava.
?Measures by New York State are warranted until the federal government implements adequate standards and enforcement for manufacturing, safety and effectiveness,? stated the report, which took two years to complete.
Loren Israelsen, head of the LDI Group, said the task force?s sentiments are very clear. ?New York state believes the federal government has abdicated its authority and role in regulating dietary supplements,? he said. ?I view (this report) as a cry for help from the states. They don?t actually want to try and regulate supplements beyond a few specific issues and are trying to either embarrass or cajole the FDA into doing its job.?
What the report does well, Israelsen said, is it ?underscores the need for the industry to be far better at self-policing, and to making cheating less attractive and the adoption of best practices more attractive. The FDA needs to do its statutory duty to enforce the Dietary Supplement Health and Education Act.?
What the report fails to do, however, is maintain proper perspective. ?Though well documented, the report vastly overstates the risks of supplements as being tantamount to pharmaceutical drug risks,? he said. ?The report also vastly underestimates the majority of users? ability to make sensible choices. Given the out-of-pocket money being spent on alternative medicines, the general citizenry is voting with their wallets.?
The American Herbal Products Association (AHPA) believes much of the suggestions contained in the report are unnecessary. ?The FDA already has the power to do what the task force report calls for,? said Karen Robin, AHPA?s director of communications. ?A state-by-state piecemeal approach is not effective for consumers or this industry.?
In addition to taking the DSHEA to task as effectively tying the hands of the FDA, the report urged the creation of an adverse-event reporting system.
On this latter point, both the LDI Group and the AHPA agreed. ?AHPA agrees that there needs to be a system for reporting serious adverse events, and that is something we have been calling for since March 2003,? Robin said. ?We are optimistic it will be created on the federal level, as it should be.?
The report cited several products of concern. One of them, the Skinny Pill for Kids, is aimed at children 6-12 years old. When taken as recommended, it supplies four times the maximum amount of niacin recommended for an 8-year-old.
While the Federal Trade Commission did file a complaint last year that the claims made by the product?s manufacturer were not supported, the product remains on the market, and such complaints rarely have any practical effect, the task force stated.
?Alleged steroid use among young kids, ephedra-like products and street drug lookalike products masquerading as products all create enormous problems for the industry,? Israelsen said. ?While many will view this report as a major negative, I see it as a useful benchmark to show us what we need to do to address concerns of regulators and to redouble efforts to crack down on cheaters.?
What happens next?
The task force?s recommendations are being reviewed by governor George Pataki?s administration. Some of the actions the report calls for would also need to be approved by the state Legislature.
Tia Powell, executive director of the task force, did not return calls by FF&N for comment. However, in an interview with The New York Times, she is quoted as saying that ensuring consumers? right to know was the group?s main motivation. ?People do not have access to information,? she said. ?Just as important, they do not know that they do not have the information.?
Israelsen predicts other states may follow New York?s lead.
?If we look at what happened with ephedra, we saw California, Texas, Ohio and New York all take independent action. I would expect these same states to follow New York, and I would toss in Iowa for good measure. I don?t think a movement is under way, but there is certainly a lot of chafing within some state governments that the FDA has done so little on issues that matter to the states.?
To view the task force?s report, visit www.health.state.ny.us/nysdoh/taskfce/.