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From: "U.S. Food & Drug Administration (FDA)" <[log in to unmask]<mailto:[log in to unmask]>>
Date: May 10, 2016 at 11:10:12 AM EDT
To: <[log in to unmask]<mailto:[log in to unmask]>>
Subject: CFSAN Constituent Update - Statement on FDA’s Actions on Labeling of KIND Products
Reply-To: <[log in to unmask]<mailto:[log in to unmask]>>




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Center for Food Safety and Applied Nutrition - Constituent Update
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Statement on FDA’s Actions on Labeling of KIND Products

May 10, 2016

In March 2015, the FDA issued a warning letter to KIND LLC<http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbXNpZD0mYXVpZD0mbWFpbGluZ2lkPTIwMTYwNTEwLjU4ODIwOTMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MDUxMC41ODgyMDkzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3Njk1OTM3JmVtYWlsaWQ9YXNwYXJrQGh1bnRlci5jdW55LmVkdSZ1c2VyaWQ9YXNwYXJrQGh1bnRlci5jdW55LmVkdSZ0YXJnZXRpZD0mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&101&&&http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm440942.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery>, because the labels and labeling of KIND’s products bore a variety of nutrient content claims but the products did not meet the requirements to make such claims<http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbXNpZD0mYXVpZD0mbWFpbGluZ2lkPTIwMTYwNTEwLjU4ODIwOTMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MDUxMC41ODgyMDkzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3Njk1OTM3JmVtYWlsaWQ9YXNwYXJrQGh1bnRlci5jdW55LmVkdSZ1c2VyaWQ9YXNwYXJrQGh1bnRlci5jdW55LmVkdSZ0YXJnZXRpZD0mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&102&&&http://www.ecfr.gov/cgi-bin/retrieveECFR?SID=bad23c28ebd662323b3ace1e3f5ee94f&gp=&mc=true&n=pt21.2.101&r=PART&source=govdelivery&ty=HTML+-+se21.2.101_165&utm_medium=email&utm_source=govdelivery>.

The FDA issued a closeout letter<http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbXNpZD0mYXVpZD0mbWFpbGluZ2lkPTIwMTYwNTEwLjU4ODIwOTMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MDUxMC41ODgyMDkzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3Njk1OTM3JmVtYWlsaWQ9YXNwYXJrQGh1bnRlci5jdW55LmVkdSZ1c2VyaWQ9YXNwYXJrQGh1bnRlci5jdW55LmVkdSZ0YXJnZXRpZD0mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&103&&&http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm497335.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery> to KIND on April 20, 2016 after an evaluation of the corrective actions taken by the firm in response to the 2015 warning letter. Some of KIND’s corrective actions included removing and amending certain nutrient content claims on product labels and labeling, as appropriate. The FDA concluded that KIND satisfactorily addressed the violations contained in the warning letter.

Following receipt of the closeout letter, KIND requested confirmation that it could use the phrase “healthy and tasty” only in text clearly presented as its corporate philosophy, where it isn’t represented as a nutrient content claim, and does not appear on the same display panel as nutrient content claims or nutrition information. In our discussions with KIND, we understood the company’s position as wanting to use “healthy and tasty” as part of its corporate philosophy, as opposed to using “healthy” in the context of a nutrient content claim. The FDA evaluates the label as a whole and has indicated that in this instance it does not object.

Consumers want to make informed food choices and it is the FDA’s responsibility to help them by ensuring labels provide accurate and reliable nutrition information. In light of evolving nutrition research, forthcoming Nutrition Facts Labeling final rules, and a citizen petition, we believe now is an opportune time to reevaluate regulations concerning nutrient content claims, generally, including the term “healthy.” We plan to solicit public comment on these issues in the near future.

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