The FDA has sent shock waves in the industry pertaining to Lycopene supplements.
In a letter sent Nov. 8 from the U.S. Food and Drug Administration to American Longevity (AL), the FDA denies AL's petition for qualified health claims for lycopene, tomatoes, and tomatoes-based foods containing lycopene.
The proposed health claims say lycopene (tomatoes, tomato-based foods containing lycopene) may reduce the risk of certain forms of cancer including prostate, lung, gastric, colorectal, breast, cervical, ovarian, and pancreatic.
The FDA denies most of the claims, suggesting a few weak health claims that might hurt sales if such wording is used on the label to promote sales of lycopene supplement. In essence, the FDA rejected virtually all the strongly worded health claims.
The FDA said, "There is no credible evidence to support qualified health claims for lycopene, as a food ingredient, component of food, or as a dietary supplement, and reduced risk of any of the cancers specified in the petition."
According to American Longevity, the FDA has delayed to process its petition six times. They have been waiting for the decision for more than two years. The FDA said it needs more time to review the evidence.
Companies do not need FDA's prior approval for manufacturing and selling lycopene supplement. The FDA would intervene only when the companies make qualified health claims without prior approval, or the FDA finds the supplement or food is not safe.
Along with the letter to American Longevity, the FDA also sent a similar letter to Lycopene Health Claim Coalition and rejected the health claims they proposed and suggested a few weak claims.