Nutrition 21 subjected to FDA health claim delays
health claims petition, for Nutrition 21's submission linking
chromium picolinate with a reduced risk of insulin resistance, type
2 diabetes and related disease, writes Jess Halliday.
The company issued a statement saying it has agreed to the 60-day extension, and that it is
"taking measures to facilitate a timely decision".
The decision has already been delayed several times, having been initially expected in July 2004.
President and CEO Gail Montgomery said: "The implementation of our business strategy does not rely on the outcomes of our petition.
"Fortunately, our current advertising and product label claims have performed well in consumer market research and our product distribution will not be limited in any way. Independent of our effort to secure qualified health claims, we will continue to execute our marketing plans to accelerate consumer demand for our chromium picolinate products."
Nutrition 21's petition consisted of more than 50 scientific studies supporting the safety and efficacy of chromium picolinate - and the body of evidence has continued to grow since the submission was made in January 2004.
Amongst the other companies whose health claims petitions have been dogged by the FDA's delays are American Longevity and Lycored.
The review period for Lycored's tomato lycopene/prostate cancer health claim has now been extended to August 12, 2005.
A decision over American Longevity's petition for the link between tomatoes, tomato-based products, and lycopene supplementation and prostate, lung, and stomach cancers has been delayed three times, and the latest date given for a decision was June 13. A spokesperson for the company said that no news has been received as yet, but that it is expected within the next few days.
The FDA has cited lack of resources as the cause of the delays.
Despite this, American Longevity remains a staunch supporter of the health claims initiative and recently launched its 'Live Free or Die' campaign to raise funds for more petitions and encourage the rest of the industry to follow suit.
Steve Wallach told NutraIngredients-USA.com that it can cost as much as $100,000 to file a petition, including the acquisition of the science, compilation of reports and legal fees, but that if approved the claim can be used by the whole sector, not just the originating company.
This means that some companies are unwilling to make health claims submissions off their own back, as even if they are approved they would not give them any advantage over the competition.
