Sunday, March 12, 2023

FDA's Draft "Labeling of Plant-Based MiIk" Tries to Change the Definition of Milk!

A new draft guidance for labeling of plant-based "milk" was recently released by the FDA.  It is a well written document of 29 pages which can be reached at this link.  It covers surveys, focus groups, dietary guidelines, and other information.  There has been a long-time controversy over labeling something which is plant-based as "milk".  Plant-based "milk" products have for some time been labeled as "milk," packaged to appear like "milk", and placed in refrigerated space next to dairy milk products as an attempt to appear as "milk".  The plant-based products do not have consistent standards and the various products do not have consistent nutritional characteristics.  Dairy milk has detailed standards and government inspections to make sure that milk products are consistently produced, properly labeled, and nutritious.  It is the FDA's responsibility that labeling is clear for consumers and does not mislead the consumer for marketing purposes. 

The draft guidance initially provides clear information on this issue, but toward the end of its draft document it sides with labeling plant-based products as "milk".  There is only one reason to label plant-based products as "milk."  When labeled as "milk" and marketed beside dairy products in refrigerated space, plant-based products have increased marketing potential.  See this prior post.  If the plant-based products were labeled as "milk alternatives" they might not sell as well, but that is what they are.  

The plant-based products do provide an alternative for consumers who have difficulty eating and drinking dairy products.  They are not bad products and they do serve a purpose.  However, the nutritional characteristics are very different from milk and labeling them as milk does imply that they do have nutritional characteristics similar to real milk.  Proper nutrition is very important for youth that are in their growing years. 

Quotations from the FDA draft document are in red to clearly separate them from this author's comments in this post.  Some references of statements from the FDA document are quoted in the body of post and many additional supporting statements from the FDA document are quoted in the Appendix.

WHAT IS THE DEFINITION OF MILK?

Merriam Webster - a fluid secreted by the mammary glands 

Britannica - liquid secreted by the mammary glands; 

Oxford - the white liquid produced by cows, goats, and some other animals.

"FDA established a definition and standard of identity for milk.  Milk has since been defined as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.”"

The FDA's definition includes only cows.  What the FDA is recommending would actually change the definition of milk.  That may change it on paper, but in people's minds, milk comes from a cow.

 WHAT IS THE ISSUE?

The draft document has done an excellent job of defining the problem.  Multiple statements are made defining the issues that currently exist.

"Our analysis of the data suggest a potential public health concern related to the substitution of milk with plant-based milk alternatives that contain lower amounts of certain nutrients found in milk."

See the Appendix below for six other statements in the draft defining the issue.

The draft document statement above and other statements in the Appendix show that clearly there is a problem.

HOW BIG IS THE PROBLEM?

Plant based milk alternative products have found significant sales success.  Initially, when they were not in the refrigerated section next to milk, they had limited success.  Today, their sales are growing, and new products are being constantly developed and marketed.  Sales have reached a point that the FDA is reviewing their marketing to consider if they are misleading people and causing a nutritional shortage. 

"In 2010, one-fifth of U.S. households purchased or consumed plant-based milk alternatives."

See the Appendix below for four other statements in the draft concerning the size of the problem. 

SHOLD PLANT BASED PRODUCTS BE LABELED AS "MILK",  INSTEAD OF "MILK ALTERNATIVES?"

Throughout the document, the term "milk alternative" is used many times.  Why?  Because it properly defines the plant-based products.

"The purpose of this guidance is to provide FDA’s current view on the naming of plant-based foods that are marketed and sold as alternatives for milk (plant-based milk alternatives)."

See the Appendix below for four other statements in the draft defining labeling.

However, in the conclusion of the draft document, they recommend using only the word "milk" in the labeling, not "milk alternative" or "plant-based milk alternatives" or some other name.

NUTRITIONAL DIFFERENCES

The nutritional value of plant-based milk alternatives varies broadly.  There are no standards, and each product may add some nutritional element(s), but in general they lack the nutritional elements that milk has.

"The Dietary Guidelines identify the Dairy Group as a key contributor of calcium, protein, vitamin A, vitamin D, magnesium, phosphorus, potassium, riboflavin, vitamin B-12, as well as zinc, choline, and selenium."

"Consistently consuming plant-based milk alternatives that do not have a similar nutritional composition to milk in place of milk, without the addition of other foods to supply the missing nutrients, could lead to further inadequate intakes of nutrients of public health concern and other nutrients that pose a special public health challenge. This, in turn, could lead to adverse health effects such as impaired peak bone mass accrual, low bone mass, and osteoporosis."

See the Appendix below for six other statements in the draft on nutritional differences.

MARKETING OF PLANT-BASED "MILK"

If a product that is not milk is labeled as milk, packaged like milk, refrigerated like milk, and placed in the milk section of grocery stores, then it must be milk.  When plant-based products are labeled as milk, it probably does have a marketing advantage.  However, it is not truthful and it is misleading.  It is the FDA's responsibility to protect consumers from false and misleading food labels.

"Survey participants also said that the term “beverage” and “drink” may suggest lower quality than a product called “milk.”"

"Such description or name must not be false or misleading and is referred to as the statement of identity."

WHAT IS THE FINAL FDA RECOMMENDATION?

In the final pages of the document, the FDA is suggesting naming plant-based products as milk, as covered in the FDA quotation below.  The cartons or bottles would carry the name milk in bold print, with a smaller, brief, and confusing message about the short comings of milk alternatives.

The fact is that plant-based alternative drinks are not the same as what has been known as milk for hundreds of years.  Many U.S. consumers do not know that a product labeled as milk is not from a cow.  The milk alternatives are not bad products, but they are not milk and should not be named as milk.

FDA recommends that plant-based milk alternatives that use the term “milk” in their name (e.g., “soy milk,” “almond milk,” “oat milk,” “almond-macadamia milk blend,” etc.) and have a nutrient composition that is different than milk (e.g., calcium, protein, vitamin A, vitamin D, magnesium, phosphorous, potassium, riboflavin, or vitamin B12) bear an additional nutrient statement on the product label describing how it is nutritionally different.

THERE IS A CLEAR PRECEDENT

In a recent post margarine was covered.  Margarine sits next to butter on the grocery shelves, but it is never called butter.  Margarine product are made by large companies like Land-O-Lakes, the best-selling butter brand in the U.S., and there is one company with a strong brand name of "Better Than Butter."  But margarine is never branded as butter.

__________________________

Appendix

Material from the FDA Draft 

"Labeling of Plant-Based Milk"


Other statements concerning "What's the Issue?"

"While some plant-based milk alternative products have “beverage” or “drink” in their labeling, the majority of products have the word “milk” in their names."

"Several consumer studies submitted in response to the notice indicate that consumers, including consumers who purchase plant-based milk alternatives, do not understand the nutritional differences between milk and plant-based milk alternatives."

"A survey reported that 53 percent of its respondents believe that plant-based milk alternatives labeled with the term “milk” in their name have a nutritional content similar to milk.

"Inadequate consumption of calcium and vitamin D can result in impaired peak bone mass accrual, low bone mass, and osteoporosis. Although calcium and vitamin D are important across the lifespan, calcium and vitamin D are critically needed during the time period when peak bone mass is still actively accruing (adolescence through 30 years of age)"

"Plant-based milk alternatives are non-standardized foods as no definition or standard of identity has been prescribed for them by regulation."

"Therefore, consistently consuming plant-based milk alternatives that do not have a similar nutritional composition to milk in place of milk, without the addition of other foods to supply the missing nutrients, could lead to further inadequate intakes of nutrients of public health concern."


Other statements concerning "How big is the Problem?"

"From 2017 to 2019, sales of plant=-based milk alternatives increased nearly 15 percent reaching $2 billion, with refrigerated products accounting for approximately 90 percent and shelf-stable products accounting for around 10 percent."

 "The variety of plant-based milk alternatives available in the marketplace has also greatly expanded from soy, rice, and almond to include cashew, coconut, flaxseed, hazelnut, hemp seed, macadamia nut, oat, pea, peanut, pecan, quinoa, and walnut-based."

"More than a third of respondents to a Consumer Reports survey said that in the past year they have purposely used plant-based milk alternatives as a substitute for milk ."

"More than a third of respondents to a Consumer Reports survey said that in the past year they have purposely used plant-based milk alternatives as a substitute for milk."


Other Statement concerning "milk" vs. "milk alternatives"

"These studies indicate that consumers understand that plant-based milk alternatives do not contain milk"

"In 2010, one-fifth of U.S. households purchased or consumed plant-based milk alternatives."

"Consequently, a plant-based milk alternative may be labeled with the term “beverage,” “drink,” or “milk.”

 "While “plant-based” or “plant” may be used to describe a plant-based milk alternative, we do not recommend using only these terms in the name of the food. “Plant-based milk” is not the common or usual name of plant-based milk alternatives."


Other Statements concerning "Nutritional Differences"

"Depending on calorie needs and age, the Dietary Guidelines, 2020-2025 recommends 1⅔-2 cup equivalents (whole-fat) from the Dairy Group per day for toddlers ages 12-23 months and between 2-3 cup equivalents (low-fat or fat-free) from the Dairy Group per day for children (≥2 years of age) and adults to achieve a healthy eating pattern."

"The question of bioavailability of calcium in non-dairy products was not addressed in the modeling analysis. Calcium- and vitamin D-fortified plant-based milk alternatives are alternatives to milk to consider, but they may vary in other potentially important nutrients (e.g., protein, magnesium, phosphorus, and potassium)."

"Plant-based milk alternatives are not milk; they are made from plant materials rather than the lacteal secretion of cows. Consequently, under the FD&C Act, they may not be offered for sale as “milk.” Although many plant-based milk alternatives are labeled with names that bear the term “milk” (e.g., “soy milk”), they do not purport to be nor are they represented as milk.  The comments and information we reviewed indicate that consumers understand plant-based milk alternatives to be different products than milk. While many circumstances attending retail sale of the products are similar to those attending retail sale of milk (e.g., packaging, labeling, location in grocery store), the comments and information we reviewed indicate that consumers, generally, do not mistake plant-based milk alternatives for milk."

"Depending on calorie needs and age, the Dietary Guidelines, 2020-2025 recommends 1⅔-2 cup equivalents (whole-fat) from the Dairy Group per day for toddlers ages 12-23 months and between 2-3 cup equivalents (low-fat or fat-free) from the Dairy Group per day for children (≥2 years of age) and adults to achieve a healthy eating pattern."

"Specifically, the School Lunch Act requires that the nutritional standards for fluid milk substitute must, at a minimum, be fortified with calcium, protein, vitamin A, and vitamin D to levels found in milk.26 Citing that milk is the primary food source for riboflavin, vitamin B12, magnesium, phosphorus, and potassium for children, USDA’s Food and Nutrition Service (FNS) extended the nutrition standards for fluid milk substitute to include these additional vitamins and minerals."

"In focus groups conducted by FDA with consumers of plant-based milk alternatives, frequent mentions were made that plant-based milk alternatives may be healthier than milk because they are lower in fat and cholesterol, and do not contain animal ingredients."


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