During the latest Regulatory Update webinar, FDA Action to Modernize the Standards of Identity, Jeni Lamb Rogers, associate general counsel of supply chain at Branded, provided an overview of the Standards of Identity (SOI) and spoke to the reopening of the comment period from 2005, the withdrawal of the SOI for French Dressing in January, as well as prospects and advocacy.
The Standards of Identity cover many specialty food products and ingredients and work to set specific standards for composition, naming, and labeling. Although there is the common perception that they are outdated and irrelevant, the SOI still matter and can have legal consequences, Rogers said. She explained that the SOI are most relevant to products or ingredients like cheeses, macaroni and noodles, fruit butters, jellies, preserves, cacao, sweeteners, salad dressings, and flavorings.
Unfortunately, many smaller brands and manufacturers find out about SOI by realizing too late that an ingredient is impacted, she noted. To help avoid this, she reviewed several real-world examples involving consumer fraud litigation (chocolate and chocolate flavored, CPG Sec 515.800), unfair competition litigation (Unilever v. Hampton Creek), and trademark issues (ketchup v. salsa case). These cases have significant commercial implications that teach us more about how we should market products today, she said.
Rogers shared some hopeful news too. In 2005, the USDA and FDA proposed a joint framework for reworking the process to establish, revise, or remove SOI. She said that the comment period on this rule was reopened in 2020 and at that time, the SFA submitted comments on the proposed rule, focusing on a clearer framework with objective criteria.
The proposed rule includes four minimum standards, which would allow for removal of a standard if they are no longer met and nine additional standards, which would also need to be met to revise or add a new SOI. On its own or via a citizen petition, the FDA could revoke or add SOI using this multifactor approach, Rogers added. She reviewed the following proposed list for removal of standards:
1. Promotes honesty and fair dealing in the interests of consumers
2. Describes basic nature to not mislead consumers: uniformity
3. Reflects essential characteristics
4. Ensures food does not appear to be of better value than it is and that it can improve overall nutritional quality of the food supply
5. Contains clear and easily understood requirements
6. Permits “Maximum flexibility” in technology used
7. Harmonizes with international standards to the extent feasible
8. Is simple and consistent amount all food standards without unnecessary detail
9. Allows variation in physical attributes of the food
10. Incorporates general requirements that pertain to multiple food standards
11. Considers other relevant regulations
12. Provides terms that are not misleading to consumers
13. Uses names of ingredients/nomenclature consistent with other regulations
Since the framework proposed by the FDA is not yet final, it is looking to the industry for guidance. Rogers said that the upcoming revocation of French dressing (Final February 1, 2022) can serve as inspiration for successfully submitting citizen’s petitions.
Looking to the future, Rogers noted that the industry can expect the following:
Some academics have called for the elimination of the SOI to be replaced by a focus on food safety regulatory resources and higher priority measures.
The FDA may finalize the proposed rule for criteria this year.
In the interim, a well drafted citizen petition in the language of the proposed rule may be the most effective means to remove an SOI.
If you would like to learn more about this topic, you can watch the webinar recording here.
Disclaimer: This presentation is designed to provide general information on pertinent legal topics, and the statements are made for educational advice. They do not constitute legal advice, and do not represent the views of BRANDED, or any of its attorneys, other than Jeni. This presentation is not intended to create an attorney-client relationship between you and Jeni Lamb Rogers. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.
Related: FDA Moves to Modernize Standards of Identity; CBD Update: The Patchwork of Regulations Continues.