The US Food and Drug Administration is revoking the standards of identity and quality for frozen cherry pie. The standards are no longer necessary to ensure that these products meet consumer expectations, and revoking the standards will provide greater flexibility and the opportunity for product innovation. The action supports FDA’s goal to modernize standards of identity.

Standards of identity establish requirements related to the content and production of certain food products. Foods for which standards of identity have been established include bread, fruit jams, certain vegetable and fruit juices, and certain types of chocolate. No standards of identity and quality exist for any other types of frozen fruit pies, or for any non-frozen fruit pies, including non-frozen cherry pie. We conclude that the standards of identity and quality for frozen cherry pie are no longer necessary to promote honesty and fair dealing in the interest of consumers.

The action responds in part to a citizen petition from the American Bakers Association.

The rule is effective on April 15, 2024.

The US Food and Drug Administration (FDA) announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding the consumption of yogurt and reduced risk of type 2 diabetes, provided that the qualified health claims are worded so as not to mislead consumers, and that other factors for the use of the claim are met.

A health claim characterizes the relationship between a substance and a disease or health-related condition. A qualified health claim is supported by scientific evidence but does not meet the more rigorous “significant scientific agreement” standard required for an authorized health claim.

The FDA responded to a qualified health claim petition submitted on behalf of Danone North America that requested that the agency review the use of a qualified health claim regarding the relationship between consumption of yogurt and reduced risk of type 2 diabetes for all types of yogurts that meet the FDA’s standard of identity. The petition also noted that the evidence supports the health effects of yogurt as a food rather than related to any single nutrient or compound and thus is independent of fat or sugar content.

After reviewing the petition and other evidence related to the proposed qualified health claim, the FDA determined that there is some credible evidence supporting a relationship between yogurt intake and reduced risk of type 2 diabetes, but this evidence is limited. As noted in the petition, the association was based on yogurt as a food, rather than any single nutrient or compound in yogurt, regardless of fat or sugar content.

The FDA considers 2 cups (3 servings) per week of yogurt to be the minimum amount for this qualified health claim. The letter discusses the factors that FDA intends to consider in the exercise of its enforcement discretion for the use of a qualified health claim on yogurt and the relationship between the consumption of yogurt and a reduced risk of type 2 diabetes.

The FDA intends to consider exercising its enforcement discretion for the following qualified health claims regarding the relationship between yogurt and reduced risk of type 2 diabetes:

• “Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes. FDA has concluded that there is limited information supporting this claim.”
• “Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes according to limited scientific evidence.”

For More Information:

Qualified Health Claims

QHC Petition – Petition for the Authorization of a Qualified Health Claim for Yogurt and Reduced Risk of Diabetes

In support of innovation and more food choices for consumers,  the US Food and Drug Administration (FDA) issued a guidance for industry that describes how firms can voluntarily engage with the FDA before marketing food from genome-edited plants. The guidance reaffirms that the risk-based approach the FDA has taken for foods derived from new plant varieties also applies to foods from genome-edited plants. In addition, this guidance describes two processes through which they may voluntarily inform the FDA of the steps they have taken to ensure the safety of foods from their genome-edited plant varieties: voluntary premarket consultations and voluntary premarket meetings. These processes can help ease the pathway to market for foods from genome-edited plants, while keeping FDA safeguards in place.

Advancements in the field of plant biotechnology are bringing new food products to the marketplace. Such advancements may contribute to helping meet the needs of a growing world population and to helping address food insecurity globally. The FDA works with other US government agencies to regulate products derived from biotechnology-derived plants. This includes products that have been developed using genetic engineering and genome editing.

The FDA’s voluntary premarket Plant Biotechnology Consultation Program enables developers to engage with the agency to determine the appropriate oversight pathways to bring safe, innovative plant-based products to market. Foods from genome-edited plants must meet the same food safety requirements as foods derived from traditionally bred plants.

In this guidance, the FDA continues to recommend voluntary premarket engagement with the agency. The recommended pathway for engagement is based on a food’s risk-based characteristics. The guidance describes two processes through which developers may voluntarily inform the FDA of the steps they have taken to ensure the safety of foods from their new genome-edited plant varieties: voluntary premarket consultations and voluntary premarket meetings. The voluntary premarket meeting pathway is recommended for developers to inform the agency of their foods when a voluntary premarket consultation is not warranted based on the food’s risk-based characteristics. The agency expects this voluntary premarket meeting pathway to take less time than a voluntary premarket consultation, including because the meeting pathway is recommended for foods that are less likely to raise safety questions. The FDA continues to suggest voluntary premarket consultations for foods that have certain risk-based characteristics, as described in the guidance.

This guidance helps to improve the efficiency of the regulatory processes for biotechnology products, as directed by Executive Order 14081, Advancing Biomanufacturing and Biotechnology Innovation for a Sustainable, Safe, and Secure Bioeconomy. This guidance is also consistent with the principles in the 1992 Statement of Policy: Foods Derived from New Plant Varieties (NPV policy).

To Submit Comments

You may submit electronic or written comments about this guidance at any time. Submit electronic comments to Regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2019-D-4658 and with the title of the guidance.

For More Information

Feed Your Mind: Understanding New Plant Varieties

Request for Information: Identifying Ambiguities, Gaps, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology

Unified Website for Biotechnology Regulation

FDA’s Regulation of Plant and Animal Biotechnology Products

In order to allow importation of processed casings from the United States (U.S.), the Canadian Food Inspection Agency (CFIA) has negotiated an interim procedure with the Food Safety and Inspection Service (FSIS). This interim procedure consists of issuing a letter of guarantee (LoG) for each shipment. This LoG will be issued by the establishment where final processing step was conducted and provided to the FSIS prior to the issuance of the Official Meat Inspection Certificate (OMIC- FSIS form 9060-07 or 9060-18).

The LoG must:

• refer to the OMIC issued
• be submitted to the National Import Service Center (NISC) with relevant documentation
• accompany the original OMIC and the shipment
• be presented to CFIA inspector if an import or preventive control inspection is required
• be kept by the importer for two years after the day of the importation

The LoG will have the following text:

Letterhead of the US EST

The products certified under the Official Meat Inspection Certificate No. (FSIS Form 9060-7, or 9060-18) __ issued on __ (date) have undergone a final processing activity i.e. salting / brining in the US establishment No. __.

Signature of the exporting establishment official
Name:
Position – QA manager or alternate:
Date:

The interim procedure will be applicable until February 28, 2025. During this period CFIA will work in close collaboration with FSIS to implement a long term solution meeting applicable Canadian requirements.

If you have any questions, please contact the local CFIA area office.

The Canadian Food Inspection Agency (CFIA) has issued a Food import notice to remind importers that on February 12, 2024, the CFIA will activate the automatic verification of Safe Food for Canadians licences (SFC licences) for imports of manufactured foods. Food import transactions will be automatically rejected unless a valid licence number is declared.

If you import manufactured foods, visit Importing food with a valid Safe Food for Canadians licence to learn how to prepare for automatic licence verification, including checking to make sure your current licence is not expired.

For questions about applying for or amending an SFC licence, visit My CFIA or call 1-800-442-2342.