WASHINGTON -- The US Food and Drug Administration (FDA) published a notice on Tuesday to clarify that the effectiveness of certain provisions of the yogurt standard of identity final rule have been stayed.
The final rule, published on June 11, 2021, amended the standard of identity for yogurt and revoked the definitions and standards of identity for low fat yogurt and nonfat yogurt. Dairy standards of identity are subject to formal rulemaking procedures, which provide a 30-day period for any person adversely affected to file an objection and request for hearing.
If objections are properly filed, then the provisions to which objections were made do not go into effect (i.e., are “stayed’). Because the FDA received objections to certain provisions of the final rule within this timeframe, the affected provisions are stayed pending final FDA action on the objections.
Michael Dykes, D.V.M., president and chief executive officer, the International Dairy Foods Association (IDFA), released a statement in response to IDFA’s objections and request for a hearing on the final rule to amend and modernize the standard of identity for yogurt released in June 2021.
“Yogurt makers have been waiting 40 years for the FDA to update and modernize the yogurt standard of identity,” Dykes said. “Today, the FDA issued a notice telling us to keep waiting—and threw in a whole lot of uncertainty, to boot.”
Last July, IDFA objected to the FDA’s final rule to amend and modernize the standard of identity for yogurt released in June. In December, IDFA sent a letter to Dr. Woodcock, Acting Commissioner for FDA, reiterating our request for a hearing with FDA to resolve the industry’s objections, along with providing manufacturers sufficient time for compliance.
Today, after eight months of waiting, FDA issued a notice staying certain provisions of the yogurt standard of identity final rule. IDFA was able to leverage formal rulemaking procedures available to the dairy industry to object and, ultimately, prompt a stay of certain provisions that they deemed “detrimental” to the industry.
“Without this lever, an impractical final rule would have gone into effect, damaging yogurt makers, throwing retail establishments into confusion, and limiting choice for consumers,” said Dykes. “While a stay is helpful at this stage, IDFA’s efforts to reform the yogurt SOI will continue into an inexplicable fifth decade.
“IDFA remains deeply disappointed in the FDA process that led to the yogurt SOI final rule. After 40 years since FDA first issued standards for yogurt, IDFA and our yogurt members are back to where we started several decades ago, beseeching the FDA to work with yogurt makers to make commonsense updates to a category that has been waiting more than four decades for modernization. Without standards that have been modernized, manufacturers are unable to meet consumer demands for innovative and nutritious yogurt products. With many significant provisions stayed, IDFA will continue to work on the yogurt SOI with an aim to ensure FDA continues to move forward in responding appropriately to IDFA’s objections in a timely manner.”
Additional background on the FDA notice published today in the Federal Register:
- Stayed Provisions: FDA is staying all provisions to which objections were filed.
- Effects of Stays: However, because the 1981 yogurt SOI final rule remains in effect, the stays themselves do not necessarily allow yogurt to be formulated in a way consistent with IDFA’s proposed modifications to the rules. Specifically, consistent with the 1981 rule:
- Cream may not be added after culturing (if added, it must be included in the culturing process).
- The overall 3.25% minimum milkfat requirement remains in effect.
- Ultrafiltered milk may not be used as a basic dairy ingredient (though it may be used as an optional dairy ingredient).
- For titratable acidity (TA), there is currently no requirement in effect. This is because the 1981 rule established a TA requirement, but it was stayed after an objection was filed in 1982. The 2021 rule established a different TA requirement, but this too has now been stayed.
- Enforcement Discretion: FDA has exercised enforcement discretion to allow the following, consistent with IDFA’s requests: (1) addition of vitamin D at a level of 10% DV per RACC; (2) addition of non-nutritive sweeteners (without requiring a nutrient content claim); and (3) addition of bulky flavoring ingredients (e.g., coconut) that increase the total fat level above 3 g per RACC, as long as milkfat is 3 g or less per RACC and the product is labeled to reflect the addition of the flavor (e.g., “low fat yogurt with coconut”). The enforcement discretion is in effect until FDA decides if a hearing is justified and issues a notice accordingly.
- Hearing: FDA has not yet determined whether it will grant a hearing or make any modifications to the final rule.
- Compliance Date: FDA does not comment on the compliance date timeline once final determinations have been made on the stayed provisions. The non-stayed provisions in the 2021 final rule remain in effect and the compliance date is still Jan. 1, 2024.