Health claim rules restrict free speech, says American Longevity
awareness of the health claims petition process and to raise funds
that will allow it to make more submissions to the FDA, reports
Jess Halliday.
The company has launched a website detailing why it sees health claims as important for the food industry and consumers, and selling wristbands emblazoned with the name of the campaign, 'Live Free Or Die'.
American Longevity's Steve Wallach told NutraIngredients-USA.com that each claim costs around $100,000 for the acquisition of the science, compilation of reports and legal fees.
The wristbands are available in three values - $5, $25 and $50 - and proceeds will go towards funding future petitions made by the company.
Although the name of the campaign may seem dramatic, the website explains that it is a reference to General John Stark's famous toast to the First Amendment of the Bill of Rights. The website states the health claims campaign is "a struggle that is affiliated with the prohibition of freedom of speech".
"The Live Free or Die Organization has been created to battle for rights incumbent to us."
To date American Longevity has made three qualified health claim petitions. Two, for EPA/DHA (for cardiovascular disease risk reduction) and selenium (for cancer risk reduction and anticarcinogenic effect) have been approved.
The third, comprising scientific studies indicating that consumption of tomatoes, tomato-based products, and lycopene supplementation may reduce the incidence of prostate, lung, and stomach cancers, was submitted in 2003.
A decision was due in December 2004, but the FDA has requested three extensions to review the evidence. The response is now expected on 13 June, and Wallach said that if it is not forthcoming the company may partner with others whose claims have been held up to launch a law suit against the agency.
Wallach said that the evidence amassed for its lycopene petition was so thorough that it had to be delivered to the FDA by truck. But the volume of the material the agency has to sift through is no excuse for the delay, he said. It is the agency's own requirement, so it should ensure it has the resources to properly deal with it.
The Live Free or Die campaign is aimed at American Longevity's own distributors, consumers and other companies active in the industry. Wallach said that there are many bigger companies that would be in a strong position to pursue health claims for ingredients but, unlike patents, approved health claims can be used by company with a qualifying product, so there is no financial incentive for them.
American Longevity is a member of the National Nutritional Foods Association, but Wallach said that this is not an area in which the association is concentrating its lobbying efforts at the moment.
"It is more of a grassroots, company by company initiative."
Health claims for foods were introduced in 2003, but there have been some criticisms that they are confusing for consumers since, as the science behind them does not necessarily have to be conclusive, they have to carry wordy disclaimers. The FDA is currently carrying out research to assess consumer reception.
Wallach thinks the disclaimers do water down the message. "They are far too restrictive," he said.
But he added: "A few years ago there was no health claims petition process, so we have made some progress."
The next health claim petition that American Longevity plans to submit is for the potential of EPA/DHA to reduce the risk of sudden death from heart attack.
"We are big fans of essential fatty acids," said Wallach. "They could do a ton of good for mankind."
Although the company has already successfully petitioned on EPA, it needs to submit a fresh store of science for the new claim. Wallach hopes that it will be in a position to make the submission by the end of this year.
