Legislation

27 September 2005

Members of the Liberty Committee, (US Congress), are planning to co-sponsor a bill aimed at making accurate disease-nutrient information more visible in the US marketplace.

Made up of 24 members of Congress, the Liberty Committee strives to ensure the principles of the Declaration of Independence and the US Constitution retain a presence in modern-day legislation.

The decision to sponsor a bill follows a briefing held last Tuesday by campaigners who believe that the FDA's current health claim policies amount to 'censorship' of information on the effects of nutrients on disease. They want dietary supplements to be able to carry treatment claims, and for the FDA's approval process for qualified health claims to be expedited.

Amongst the speakers addressing Senate and House staff, who are responsible for gathering information on behalf of their respective Congressmen and Senators, was attorney Jonathan Emord who has a successful track record of legal challenges to the FDA.

Emord says that there is a mass suppression of health information in grocery stores, health food stores, and in the media since filing a health claim costs a company tens of thousands of dollars - which few can afford.

"Those with the greatest financial interest in telling you the effects of the most basic substances we consume every day cannot legally tell you", he said in a statement.

Since qualified health claims were introduced in September, the approvals process has been beset by delays. Despite pledging that a response would be given to all claims submitted within 365 days, the agency has exceeded this timeframe on a number of occasions. For example, a decision on American Longevity's lycopene/cancer petition has been postponed five times and is now more than 300 days over the original due date.

According to the speakers, such delays amount to a suppression of free speech. They claim the FDA's position on health claims has contributed to the thousands of illnesses and deaths amongst Americans.

For example, they say that the agency's withheld approval of a folic acid/neural tube defect risk reduction claim has contributed to 10,000 preventable neural tube defect births; that the prohibition on a claim linking glucosamine and chondroitin sulfate with a reduction in osteoarthritis risk and symptoms is to the detriment of 20 million Americans who suffer from the condition; and that the refusal to give the red light on claims associating saw palmetto with symptoms of enlarged prostates impacts 50 percent of men aged over 50.

Dietary supplements are not permitted to make treatment claims in the same way as drugs - a restriction that means they are not subject to the same stringent approvals processes as pharmaceuticals but rather are regulated as foods under the 1994 Dietary Supplement Health and Education Act (DSHEA).

Although the industry at large is confident that DSHEA is effective in ensuring the safety of dietary supplements, there are those who want the line between supplements and herbal products to be drawn even more boldly.

For example, in June the American Medical Association's House of Delegates adopted a resolution to encourage the inclusion of the word 'herbal' in the names of herbal supplements, and to discourage them from being packaged and advertised in such a way as to resembles the packaging and advertising of prescription drugs.

At the briefing, the FTC also came under fire for its handling of deceptive advertising cases. The campaigners claim that, under the First Amendment, it falls to the government to prove that advertising is false by a preponderance of evidence.

They said that, at present, the FTC "condemns as deceptive advertising any health benefit claim not supported in advance of advertising with scientific proof to a near certain degree".

Although many within the industry are keen to see products backed up by solid science - something that consumers are increasingly demanding - Emord and Associates said in a statement: "Proof to a certainty is extreme rarity in science."

"The FDA and the FTC routinely violate our First Amendment. Instead of trying to control the content of what is communicated and to keep all statements of nutrient-disease association out of the market, they should be in the business of prosecuting fraud that causes harm when and if they possesses proof that statements are in fact false."

Beyond the bill that the Liberty Committee plans to co-sponsor, the speakers said that there is an active, grass roots movement seeks support for legislative reform on health claims from all over the United States. They are seeking signatures on a petition to be presented to Congress in January. "The campaign for reform will continue until the bills become law", they pledge.

Source: http://www.knowledgeofhealth.com.