Modernizing Food Standards of Identity (SOI) has been on United States Food and Drug Administration’s (FDA) radar for the last 20 years, but there has been very little movement on the subject until this past year. On Wednesday, FDA announced that it is revoking the Standard of Identity (SOI) for French Dressing, which is the agency’s second move over the past year to “modernize” food SOIs. In June 2021, FDA revoked the SOI for Low-fat/Non-fat Yogurt and amended the SOI for Yogurt. This is the most involvement from FDA on Food SOIs that we have seen since the 1960s and 70s.
Despite these recent moves and FDA’s SOI modernization initiative (which is part of its Nutrition Innovation Strategy), the modernization of SOIs has been slow going. For example, FDA’s revocation of the French Dressing standard was in response to a Citizen Petition submitted by the Associations of Dressings and Sauces in 1998. We are aware that there are Citizen Petitions in place for at least seven other SOIs:
- Canned Pacific Salmon (since 1987)
- Ultrapasteurized Egg (since 1989)
- Parmesan Cheese (Since 1999)
- Canned tomatoes (since 2002)
- Canned Tuna (since 2014)
- Ruby Chocolate (since 2019)
- Pasteurized Standardized Cheeses (since 2020)
These Petitions were filed in conjunction with Temporary Marketing Permits (TMP) issued by FDA. A TMP allows manufacturers to market test products that deviate from a SOI. These TMP applications and accompanying Citizen Petitions date back as early as 1987. In the above cases, there has been a need to change the SOIs. The is typically due to consumer preference and acceptance of new ingredients (e.g., ruby chocolate, canned tomatoes), the absence of ingredients (e.g., canned pacific salmon), or issues in complying with technical aspects of the SOI itself (e.g., measuring “drained weight” in a tuna can).
Despite the collection of TMP data and the need for revision, FDA has not acted and the TMP applicants have resorted to effectively marketing products under their TMP for decades in some cases. FDA may be moving slowly on its SOI modernization efforts because there is no clear policy on how or when the agency should amend a SOI. In 2005, the FDA and USDA proposed, but never finalized a rule on “General Principles and Food Standards Modernization” that aimed to provide the agency with guiderails to establish, revise, or eliminate a SOI. In 2020, the FDA reopened the comment period for the 2005 proposal, after the agency explored “horizontal approaches” to SOI modernization in 2019.
Moving forward there is a lot to do to update SOIs. Finalizing the General Principles may expedite the process so both industry and FDA are clear on when and how to establish, revise, or eliminate a SOI. In addition, dedicating resources to modernization efforts would help speed the evaluation of Citizen Petitions and consumer expectation data collected under TMPs. Our hope is that FDA continues to move the ball on SOI modernization.
Please contact OFW Law for further information.