Exploring the sense and nonsense of food and health

FDA Health Claims: Are They Carved in Stone?

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Food and supplement labels are permitted by the FDA to include a number of health claims if they are relevant to the product. They are designed to help consumers choose products that that may have a relationship to reducing a risk for a particular disease or health related condition. These statements or claims must meet one of the following requirements:

  1. The first is the most stringent. These are called Authorized Health Claims: Based on Significant Scientific Agreement. An example: Calcium intake and calcium and vitamin D and the risk of osteoporosis.
  2. The claim should be based on a statement of support from an appropriate scientific body, e.g. the National Academy  of Sciences, and called Authorized Health Claims: Based on Authoritative Statement  Example: Whole grain foods and the risk of heart disease and certain cancers.
  3. When there is emerging but not well-established evidence for a reduced risk of a disease, they are called Qualified Health Claims. These must be accompanied by a statement explaining this so they do not mislead the consumer.

Source: Smolin and Grosvenor, Nutrition: Science and Application, Third Edition

However, these claims are not carved in stone. Recently the FDA is re-examining the once established claim about soy protein.

FDA may revoke soy protein/heart disease health claim

The FDA is proposing to revoke the currently authorized claim that consuming soy protein reduces the risk of heart disease. FDA-authorized health claims are intended to reflect well-established relationships based on the most robust level of scientific evidence. To date, 12 such claims have been authorized. The soy-protein claim has been permitted on packaged foods since 1999. In 2000, the American Heart Association Nutrition Advisory Committee concluded that is was prudent to include soy protein in a diet that is low in saturated fat and cholesterol. However, subsequent AHA reviews concluded that although very large amounts of soy protein (more than half the daily protein intake) may lower LDL cholesterol, (a) the experimental data were from individuals with very high cholesterol levels, (b) the reduction is small, (c) there was no improvement in other blood lipid levels or blood pressure, and (d) any direct benefit on cardiovascular health is minimal at best. [Jones DW. Letter to FDA Division of Dockets Management, Feb 19, 2008] A statement released with FDA’s recent announcement appears to agree with the AHA position. [Statement from Susan Mayne, Ph.D., on proposal to revoke health claim that soy protein reduces risk of heart disease. FDA news release, Oct 30, 2017] This is the first time the FDA has proposed to revoke an authorized claim.

Source: Stephen Barrett, M.D. Consumer Health Digest, Nov. 12, 2027


One thought on “FDA Health Claims: Are They Carved in Stone?

  1. Good to know, so interesting!


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