What Do We Know About Plant-Based Products & Dairy Foods – FDA Wants to Know

The FDA notes an emergence and expansion of plant-based products that are labeled in a manner that includes the names of dairy foods such as “milk” (i.e. “soy milk” and “almond milk”); “cultured milk” (i.e. “coconut kefir”); “yogurt” (i.e. “soy yogurt” and “almond yogurt”); and “cheese” (i.e. “vegan mozzarella cheese”).  You will often find these types of products located near or along with their dairy counterparts and in similar packaging.  However, the FDA notes these plant-based products may not have the same basic and essential characteristics, including a lack of certain nutrients needed to meet the recommendation for dairy food group intake in the “2015-2020 Dietary Guidelines for Americans”.  For certain uses, these plant-based products may not be suitable substitutes for their dairy product counterparts under FDA regulations.

On September 28, 2018, due to this emergence and expansion, FDA published a notice requesting information on how consumers use plant-based products whose names include terms such as “milk,” “yogurt,” and “cheese,” and how consumers understand those terms when used in such product names.

In seeking out this information, the notice provides background of the statutory authority over food labeling in this context.  Generally, FDA’s statutory and regulatory authority over food standards is set forth in § 401 of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”).  This is used to promote honesty and fair dealing in the interest of consumers.  Not surprisingly, FDA prohibits food labeling that is false or misleading (i.e. “misbranded”) under § 403(g) of the FD&C Act.  Food is misbranded if it purports to be, or it is representing, as a food for which a definition and standard of identity has been prescribed by regulation, unless of course the food confirms to the definition and standard.  Factors that are considered in determining whether a food is misbranded include, not only the name and labeling on the food, but also the appearance of the packaging and where the food is displayed in the store.

The notice further explains there are two general categories of food under the FD&C Act:  (1) Standardized Food and (2) Non-Standardized Food.  See § 401 and 403(g).  Both categories of food are generally identified by their common and usual names.  This is the name by which it is known by the American public and generally established by its common usage.  See 21 CFR 102.5(d).

For “Standardized Foods”, the common or usual name must be declared on the principal display panel of the label when the food is in package form.  Examples include milk, cultured milk, yogurt, and cheese.  See § 101.3(b)(1) (21 CFR 101.3(b)(1)).

“Non-Standardized Foods” also have the requirement to bear the common or usual name of the food on their labels when such a name exists.  See § 101.3(b)(2).  However, the potential for misbranding may arises in circumstances where the common or usual name of a non-standardized food is misleading to the consumer.  Most notably, this concern arises with plant-based products that resemble dairy foods such as milk, cultured milk, yogurt and cheese, yet may lack the standards of identity, and are therefore non-standardized foods.

In sum, due to the above, FDA is seeking consumer input and has published notice seeking information in the following five (5) areas:

  1. Current market conditions and labeling costs of plant-based products;
  2. Consumer understanding, perception, purchase and consumption of plant-based products, particularly those manufactured to resemble dairy foods such as, for example, milk, yogurt and cheese
  3. Consumer understanding regarding the basic nature, characteristics , and properties  of plaintiff-based products
  4. Consumer understanding of the nutritional content of plant-based products and dairy foods and the effect, if any, on consumer purchase and use; and
  5. The role of plant-based products and dairy foods in meeting the recommendations in the dietary guidelines.

Pursuant to the notice, public comments are due within 60 days of publication of the notice in the Federal Register.  Life Science Matters will continue to monitor this issue and provide any relevant updates during or after the comment period.  This notice, in itself, further shows that FDA is continuing to focus its efforts on food labeling regulations and factor in how consumer knowledge and understanding relate to certain products under these regulations.

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