FDA Warning Letter – Misbranding – Whole grain benefits and not authorised claims

Here’s the FDA position about not authorised digestive claims in USA:
FDA WARNING LETTER – MAR 10, 2015
The Food and Drug Administration (FDA or we) reviewed the label for your Post Great Grains Digestive Blend (vanilla graham) product in September 2014. Based on our review, we have concluded that your Post Great Grains Digestive Blend (vanilla graham) product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) [Title 21, United States Code (U.S.C.), sections 301 et seq.] and the applicable regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). You can find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.
Your Post Great Grains Digestive Blend (vanilla graham) product is misbranded within the meaning of section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] in that the labeling bears health claims that were not authorized by FDA.
Your product label bears claims that characterize the relationship of a nutrient to a disease or health-related condition. Specifically, your product label bears the following claims: “By consuming at least 48 g of whole grains per day you can support healthy digestion and reduce the risk of several chronic diseases like heart disease and diabetes. New Great Grains Digestive Blend cereal has 41 g of whole grain which is more than 85% of the daily recommended amount!”
A health claim expressly or by implication characterizes the relationship between a substance and a disease or health-related condition [21 CFR 101.14(a)(1)]. Substance means a specific food or component of food [21 CFR 101.14(a)(2)]. The whole grains that are a component of your product are substances within the meaning of 21 CFR 101.14(a)(2), and your label characterizes the relationship of these substances to diseases or health-related conditions (i.e., heart disease and diabetes). Because the product label bears health claims that were not authorized by FDA either by regulation [see section 403(r)(3)(A)-(B) of the Act [21 U.S.C. § 343(r)(3)(A)(B)]] or under authority of the health claim notification provision of the Act [see section 403(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(G)]], the product is misbranded within the meaning of section 403(r)(1)(B) of the Act.
FDA has authorized health claims linking the consumption of whole grain foods to reduced risk of heart disease through the notification procedure in section 403(r)(3)(C) of the Act. Of those authorized claims, the ones closest to the claims on your product label are as follows:
  • “Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol, may help reduce the risk of heart disease and certain cancers.”[1]
  • “Diets rich in whole grain foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease.”[2]
The claim “By consuming at least 48 g of whole grains per day you can… reduce the risk of several chronic diseases like heart disease…” is not consistent with either of the above-cited claims that are authorized under section 403(r)(3)(C) of the Act. For example, your claim leaves out any reference to other plant foods and to foods low in saturated fat and cholesterol.
In addition, in a September 11, 2013, letter announcing that FDA would consider the exercise of enforcement discretion[3], FDA articulated two claims for which the agency intends to consider the exercise of enforcement discretion, each of which references the “very limited scientific evidence” linking the consumption of whole grains with a reduced risk of type 2 diabetes. Those claims are as follows:
  • “Whole grains may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very limited scientific evidence for this claim.”
  • “Whole grains may reduce the risk of type 2 diabetes. FDA has concluded that there is very limited scientific evidence for this claim.”
The claim “By consuming at least 48 g of whole grains per day you can… reduce the risk of several chronic diseases like…diabetes…” is not consistent with either of the above-cited claims for which FDA announced it would consider the exercise of enforcement discretion.   For example, your claim leaves out any reference to the very limited scientific evidence linking the consumption of whole grains with a reduced risk of type 2 diabetes.
For all of the above-noted reasons, your product is misbranded within the meaning of section 403(r)(1)(B) of the Act.
If you are aware of additional evidence that would support a health claim by regulation or a qualified health claim, we encourage you to submit a petition pursuant to section 403(r)(4) of the Act [21 U.S.C. § 343(r)(4)]; see also FDA’s guidance on qualified health claims, which includes the procedures for submitting qualified health claim petitions.
(Source: FDA website)

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