The proposed compliance date of Jan. 1, 2020, is intended to align with FDA’s proposed rule to extend the compliance dates for the changes to the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from July 26, 2018, to Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales.
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Failure to comply with the BE food disclosure requirements is prohibited, but the consequences are relatively feeble. The AMS enforcement authority is limited to enforcing compliance through records audits and examinations, hearings, and public disclosure of the results of audits, examinations, and hearings. The Final Rule does not authorize civil penalties or recall authority for violations.
During the rule-making process, some argued that accountability is a key aspect of a meaningful labeling claim, and that rigorous enforcement provisions were necessary to effectuate the rule. AMS asserted that the enforcement process, which again includes a complaint process, investigations, audits, hearings of limited scope, and resulting notifications to both regulated entity and the public, sufficiently meets the requisite enforcement needs.
Time will tell whether and how these regulations may need to be altered, added to, refined, or repealed. While the Final Rule will not be perfect for every consumer every time, we am pleased that the Final Rule, whatever its faults, will provide consumers with additional information from which to answer that age-old question: To BE or not to BE.
Stevens, a food industry attorney, is a founding member of Food Industry Counsel, LLC. Reach him at firstname.lastname@example.org. Chappelle is also a food industry lawyer and consultant at the same organization. Reach him at email@example.com.