On November 5, an announcement in the Federal Register revealed new FDA guidance documents for industry with respect to Nutrition and Supplement Facts Labels. The update was in response to comments received on the draft guidance published in the Federal Register of January 5, 2017. Comments were received mostly on compliance dates and labeling requirements for added sugars. The guidance was revised in response to the comments and is now final.
This final guidance is for the two Final Rules published in the Federal Register of May 27, 2016. The two final rules were related to Nutrition Facts Labeling and Serving Sizes of Foods.
The two final rules in the new FDA guidance documents provided two compliance dates distinguishing between manufacturers with $10 million or more in annual food sales (July 26, 2018) and manufacturers with less than $10 million in annual food sales (July 26, 2019). The FDA has extended these dates to January 1, 2020 (manufacturers with $10 million or more in annual food sales), and to January 1, 2021 (manufacturers with less than $10 million in annual food sales).
The FDA has issued a request for information about the prevalence and severity of sesame allergies in the U.S. According to a statement released by FDA Commissioner Scott Gottlieb:
“We’re beginning to see evidence that sesame allergies may be a growing concern in the U.S.”
A handful of studies, for example, suggest that the prevalence of sesame allergies in the U.S. is more than 0.1 percent, on par with allergies to soy and fish.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) currently acknowledges eight major food allergen categories: milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. The disclosure of these allergens on food packaging is required by the FD&C Act. Currently, sesame is not required to be disclosed as an allergen, and in some circumstances, sesame may be exempt from being listed by name in the ingredient statement on food packages.
The information gathered from FDA’s request may be used to initiate possible regulations that would require sesame to be labeled as an allergen on food packaging. The comment period for the information request opens October 30, 2018 and will remain open for 60 days.
Note that in Canada, sesame seeds are already on the list of Priority Allergens and warning statements are required on all food packages that contain sesame seeds. This means the precedence has already been set in regulatory jurisdictions outside the USA.
In summary, the regulations and requirements for food labeling are ever-evolving, and it is up to each manufacturer to keep up to date and to ensure their food packaging is compliant with all applicable laws. We encourage anyone with difficulties or questions on the new FDA guidance documents, or requiring assistance with regulatory compliance for foods and dietary supplements in general, to reach out to dicentra for further discussions.
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dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can also assist you with your classification determinations for delivery systems or combination drug-device products.