FDA delays decision on another health claim

The California based supplement company​ said the FDA was supposed to issue its decision on the health claim on 24 December, but had informed the firm last week that a decision would not be made until 11 February 2005.

"In recent months the agency has asked for extensions in its review of seven other pending qualified health claim petitions citing a lack of agency resources,"​ said American Longevity.

Kimberly Rawlins, spokesperson for the FDA, said that that she was unable to confirm or deny this as the government body was unable to comment on any pending health claims.

It is requesting that the FDA - under the recent health claim rules - allow the use of dietary supplement health claims for lycopene, tomatoes, lycopene-containing tomato-based products, and cancer.

American Longevity initially proposed that lycopene may reduce the risk of cancer, prostate cancer and lung cancer and that tomatoes and tomato-based products may reduce the risk of lung cancer.

Then in January, acting through the law firm Emord & Associates, the company added a string of new health claims to the proposed list including : 'Lycopene may reduce the risk of gastric cancer, colorectal cancer, breast cancer, cervical cancer, endometrial cancer, ovarian cancer and pancreatic cancer' and 'tomatoes may reduce the risk of cancer'.

The average daily intake of lycopene, a carotenoid responsible for the red color of tomatoes, watermelon, papaya, and pink grapefruit, is approximately 25 milligrams, with 50 per cent of this in the form of processed tomato products. It is known to have antioxidant and anticarcinogenic activity. American Longevity compiled scientific studies demonstrating that consumption of tomatoes, tomato-based products, and lycopene supplementation may reduce the incidence of prostate, lung, and stomach cancers.

In February 2003, the FDA gave the green light for the use of two health claims, with cancer risk reduction and anticarcinogenic effect claims, proposed by Wellness Lifestyles - a subsidiary of American Longevity - for the labeling of dietary supplements containing selenium in daily dose amounts of 400 micrograms or less.

Health claims are subject to pre-approval by the FDA and must meet a "weight of the evidence"​ standard. The FDA will respond to health claim petitions in one of three ways. If the claim meets the "significant scientific agreement" standard, FDA will authorize the claim and consider expediting publication to permit faster use in the market.

If the claim does not meet the "significant scientific agreement"​ standard but does meet a "weight of the evidence"​ standard, under which supporting evidence outweighs negative evidence, FDA will exercise "enforcement discretion,"​ allowing companies to use the claim with an appropriate qualifier. If the claim does not meet either standard, the FDA will deny the petition.

The lycopene market is expanding significantly, with growth rates forecast at over 100 percent in a recent report on the carotenoids market from Frost & Sullivan. The report values the ingredient at $34 million in 2003, and with growing demand, new sources of the nutrient will attempt to lift this figure further.

Nutrition 21 announced earlier this month that the FDA has extended the review period for the company's qualified health claim linking chromium picolinate with a reduced risk of insulin resistance, type 2 diabetes and related disease conditions by 90 days.