AHPA joined 16 other trade associations in a Aug. 21 letter to the Food and Drug Administration (FDA) to request more time for small businesses to understand and comply with the Agency’s new, wide-ranging nutrition labeling regulations.
FDA issued a final rule updating US food and supplement labeling laws on May 27, 2016. The rule amends 21 CFR §§ 101.9 and 101.36 and has a wide range of effects on both food and supplement product labeling, including changes to the format of the supplement facts panel and revisions to the Daily Reference Values (DRVs) of many nutrients.
In the Aug. 21 letter, AHPA and several co-signatory members of the Food and Beverage Issue Alliance (FBIA) asked FDA to provide small companies with the same enforcement discretion it has already offered larger ones: a one-year extension of time to come into compliance with the complex new labeling rules. If adopted by FDA, small companies would also receive a year of enforcement discretion, moving the compliance date from January 1, 2021 to January 1, 2022.
FDA previously announced that companies with $10 million or more in annual sales will receive an additional year to meet the revised nutrition labeling regulation, giving them until January 1, 2021 to enter full compliance. However, FDA has remained silent about the issue of enforcement discretion for smaller companies. The letter from FBIA identifies that smaller companies are impacted by the same challenges of product reformulation, the disposal of old labels, and the design and production of new labels. The letter additionally notes that small companies are every bit as affected by the current COVID-19 pandemic as larger ones.
AHPA provides free guidance to industry on Federal Labeling Requirements for Herbal Dietary Supplements.