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4 FDA Guidance Topics That Could Affect Specialty Food

Specialty Food Association

On January 31, the FDA Center for Food Safety and Applied Nutrition and Office of Food Policy and Response released a list of 30 draft and final guidance topics that are a priority for the FDA Foods Program to complete during 2022. FDA expects to publish these documents by December of this year or earlier.

FDA Guidances are documents that explain the agency’s interpretation of, or policy on, a regulatory issue. The FDA prepares Guidances primarily for industry to address the design, manufacturing, and testing of regulated products; scientific issues; content and evaluation of applications for product approvals; and inspection and enforcement policies. Guidances are not legally binding; they reflect FDA’s current thinking on topics and assist industry to understand and follow the regulations.

Here are synopses of four significant Guidances and how they could affect the specialty food industry.

Labeling of Plant-Based Milk Alternatives

This issue has been under consideration by the FDA for more than five years. As part of its strategy entitled “The New Era of Smarter Food Safety,” FDA is considering approaches to modernize standards of identity, which are regulations that set requirements for the content and sometimes the methods used to produce certain foods. For instance, the standard of identity for milk states it is a “lacterial secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.”

Plant-based milks are the largest alternative product, with sales of $2.5 billion in 2020, according to SPINS data. To address the labeling of plant-based milk, cheese, yogurt, and other dairy products, FDA issued a request for public comment in September 2018. It stated, “The FDA supports choice and innovation in the marketplace and recognizes that some consumers may prefer to use plant-based products instead of dairy products for a variety of reasons, including an allergy or lifestyle choice. But the FDA has concerns that the labeling of some plant-based products, which can vary widely in their nutritional content, is leading consumers to believe that those products have the same key nutritional attributes as dairy products.”

FDA received more than 11,900 comments, with more than three-quarters advocating for the use of dairy terminology. Many followed the lead of the Plant Based Foods Association, which urged FDA to re-affirm its long-standing position to allow use of the term “milk” with appropriate qualifiers like “soy,” “almond,” “oat,” or “plant-based.”

Since the new FDA Commissioner Califf took office in December, the National Milk Producers Federation, and other dairy industry groups have asked FDA to disallow plant-based products from using dairy descriptors.

Although a decision is expected by summer, this long boiling controversy still has a way to go.

Labeling of Plant-Based Alternatives to Animal-Derived Foods

This is another hot topic for the plant-based meat and dairy industries. Plant-based alternatives to meat products are growing at a huge rate as consumers choose these products for a variety of reasons, including environmental concerns and health. A report by Bloomberg Intelligence states that global sales of plant-based meat alternatives will reach $28 billion in 2025 and $74 billion by 2030. According to the Good Food Institute, much of the growth is from flexitarians, who add plant-based meat alternatives to their diet yet are not dedicated vegetarians or vegans. Major manufacturers such as Archer Daniel Midlands, Cargill, and Ingredion are developing products for the market.

Regulation of plant-based meat alternatives, such as those using soy, beets, and other vegetable products, are regulated by FDA. Impossible Burger and Beyond Meat are both plant-based. Cell-based meat alternatives, not yet as commercially available as plant-based, are regulated jointly by FDA and USDA.

FDA plans to publish a Draft Guidance for Industry in 2022.

Questions and Answers About Dietary Guidance Statements in Food Labeling

Dietary guidance statements address the role of a specific dietary pattern or of a general category of food in maintaining good health. Examples would be oat products which are often described as “heart healthy” or fruits and vegetables as “an important part of a balanced diet.” Dietary guidance statements used on food labels must be truthful and non-misleading but are not regulated as strictly as “health claims.” They do not need to be pre-approved by FDA.

There has been a proliferation of dietary guidance statements over the past 10 years, including statements such as “improves gut health” and “increases antiviral activity.” The pandemic buoyed the use of these statements, often confusing consumers. FDA will address the concerns and conclusions about these claims through a Question and Answer Draft Guidance.

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

The Foreign Supplier Verification Program Rule went into effect in January 2016, with compliance dates of May 2017 for large importers, March 2018 for small businesses, and March 2019 for very small businesses. Specialty Food Association was very active in the decision process, testifying at three public hearings and submitting written comments.

The 108-page Draft Guidance for Industry was published in January 2018. The FDA has received scores of comments since then and plans to update the Guidance in 2022. Since many in the import community are still unsure of what they need to do to comply with the law, the updated guidance will be welcome news, especially for small and very small importers.

Among the other issues affecting the specialty food industry to be addressed in 2022 are Food Allergen Controls and Classifying Food as Ready-To-Eat or Not-Ready-To Eat.

Related: FDA Releases Food Safety Blueprint; What to Expect From FDA in 2022.