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.

The US Food and Drug Administration (FDA) has released a revised draft Introduction and Appendix 1 to the multi-chapter draft guidance for industry titled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft Guidance). The changes address comments the Agency received on the drafts that were made available in 2016; and provide additional context and information on hazards in food categories of current interest to ensure that the available draft documents adequately reflect the Agency’s current thinking on the most relevant food safety hazards.

The revised introduction includes additional information to better explain the purpose of the guidance and provide general information applicable to all chapters. This includes an expanded glossary of terms that are used and defined in later chapters, and the addition of three new sections on training, references, and resources. The training section provides general information on training relevant to the PCHF rule. The references section includes a comprehensive bibliography of references that have been used in certain chapters of the guidance, along with references we expect to include in future chapters that will be released. The new resources section features a compilation of resources that may be useful to someone using the guidance.

The second document released today is a revised draft of Appendix 1 “Known or reasonably foreseeable hazards (“potential hazards”).” As informed by stakeholder concerns over specific hazard-commodity associations and the Agency’s use of the Appendix during inspections, the FDA has made significant changes that include:

• The addition of new sections and descriptions meant to better explain the purpose of the Appendix, how it was developed and how it should be used;
• Revisions to the product categories identified within the Appendix to better reflect food ingredients rather than finished products;
• Replacement of a series of process-related hazard tables with a discussion of those hazards;
• An updated discussion on food allergen hazards; and
• Citations to scientific, technical and regulatory information references, particularly for less-commonly known hazards identified for different food categories.

Both the draft Introduction and Appendix 1 are available for public comment. The FDA encourages comments to be submitted to regulations.gov under Docket No. FDA-2016-D-2343 within 120 days of publication in the Federal Register.