Failure to include adjusted protein percentage on protein-touting products can be misleading

Rausch v. Flatout, Inc., — F.Supp.3d —-, 2023 WL 2401452,
No. 22-cv-04157-VC (N.D. Cal. Mar. 8, 2023)

I love a good summary:

When a manufacturer advertises the
amount of protein in a product on its package, the Food and Drug Administration
requires the manufacturer to include additional information on that product’s nutrition
facts panel: the manufacturer must provide the “percent daily value” for
protein based not on the raw amount of protein in the product, but on the
amount of protein that the human body will actually absorb. The question
presented in this case is whether a manufacturer’s failure to include that
percent daily value renders its other statements about protein quantity
misleading—both within the meaning of the FDA’s regulations and state law. The
answer is yes.

While “consumers often pick products based on their protein
content, “not all protein is created equal.” Protein’s constituent parts are
amino acids; a high-quality protein contains “all nine amino acids in the right
proportions for protein synthesis.” Also, “most plant proteins are only 85%
digestible, so 15% of the protein from a plant source will just pass through
your body.” The FDA requires all products to include the grams of protein in a
serving, without needing adjustment for amino acid content or digestibility
(together “quality”). However, if there’s a “protein claim” anywhere else on
the label, including both “Excellent source of protein!” or just “20g of
protein,” the FDA requires the manufacturer to include the “corrected amount of
protein per serving,” expressed as a percent of daily value. This is corrected
amount is calculated by using a discount factor that accounts for the protein’s
amino acid content and digestibility.

Flatout sells a variety of products, including flatbreads
and pizza crusts. Several of these products allegedly advertise their protein
content on the front of their labels, but they fail to include the
quality-adjusted percent on their nutrition facts panels. Thus, a consumer
would only absorb about half of the protein in Flatout’s Flatbread, but that
isn’t disclosed.

Rausch sued for UCL unlawfulness and the usual California
claims including UCL fraudulent claims. California’s Sherman Act incorporates
the FDCA and regulations; Rausch alleged that the protein statements violated
the FDA’s requirement that Flatout include the quality-adjusted figure and a
more general FDA regulation that prohibits misleading “nutrient content

The second theory required a bit more unpacking because of Nacarino
v. Kashi, 584 F. Supp. 3d 806 (N.D. Cal. 2022). There, like here, the label on
Kashi’s cereal stated that the cereal had “11g” of protein, but that figure was
not adjusted for the protein’s quality. But there were no allegations that
Kashi failed to include the quality-adjusted percent on the cereal’s nutrition
facts panel (and the Kashi requested judicial notice that it had done so). In
that context, the court held that “making a statement about protein quantity on
the front of the package—without including a disclaimer about protein quality
also on the front of the package” didn’t violate the prohibition on misleading

That wasn’t this situation, but Nacarino also said
that requiring the use of the quality-adjusted percentage in the nutrition
facts panel didn’t mean that statements of protein content would be misleading in
the absence of that disclosure:

To hold otherwise would be to find
that an FDA-approved protein measurement technique is inherently misleading.
This is not a plausible interpretation of the regulations. A better reading is
that the FDA recognizes that in situations where consumers are drawn to a
product for its protein content—those situations in which a manufacturer is
touting its product’s protein on its packaging—consumers deserve additional
information in the Nutrition Facts label. This is not to remedy an otherwise
misleading figure, but to supply protein-conscious consumers with information
that gives them further assistance in deciding what to buy.

The court here disagreed:

The better reading of the FDA’s
regulations is that prominently advertising a product’s protein quantity
outside of the nutrition facts panel is misleading (within the meaning of the
Food, Drug, and Cosmetic Act and the FDA’s regulations), if the manufacturer
doesn’t include the quality-adjusted percent in the nutrition facts panel. As a
matter of common sense, it’s reasonable to think that small text in the
nutrition facts panel is less likely to mislead a consumer than text
advertising the protein content on the front of a label. When a manufacturer
chooses to emphasize a product’s protein content elsewhere on a label, the
manufacturer is implicitly suggesting that the product is a good source of
protein. In effect, it’s encouraging consumers to buy the product based off
that feature. That’s not the case when the manufacturer includes the amount of
protein in the nutrition facts panel (something manufacturers must do on all
products). Thus, the FDA’s regulations are best understood as reflecting a
determination that when a manufacturer emphasizes a product’s protein content,
that statement is misleading without including information about the product’s
protein quality on the nutrition facts panel.

Why didn’t the FDA require all manufacturers to disclose the
quality-adjusted percent on all products Apparently it was, at least at the
time, expensive to calculate a product’s precise amino acid score; the FDA
decided not to impose those additional costs generally because Americans
generally consume enough high-quality protein in their diets. But, it reasoned, “where a
manufacturer decides to make a protein claim, the ‘the burden and expense’ of
calculating the percent are ‘voluntarily assumed by the manufacturer.’” The court here concluded that FDA’s decision
to “spare most manufacturers from the expense of calculating the
quality-adjusted percent does not mean that protein statements (made outside of
the nutrition facts panel) can never be misleading.”

Flatout responded that the quality-adjusted percent was
essentially meaningless, so it did nothing to remedy the potentially misleading
statement of protein quantity, because “reasonable consumers” do not possess
“the regulatory or mathematical skill” required to use the percent daily value
to convert the “grams of protein stated on the label into digestible protein.”

True enough! But not helpful to Flatout:

The FDA is generally skeptical that
consumers know exactly how much of any nutrient they should be consuming every
day. That’s why the FDA thinks the percent daily value is helpful: it gives
consumers a sense of how the food might fit into their broader nutritional
needs….  That doesn’t require any
complicated math, and that information puts the potentially misleading protein
statement in context. The expectations created by statements like “excellent
source of protein!” or “20g protein!” can be tempered by looking at the percent
daily value.

Indeed, parsing the text, the court determined that the
quality-adjusted percentage disclosure requirement was not promulgated under
the general nutrition rules—then it would have to be on all nutrition labels—but
under FDA’s authority to regulate misleading labels. Thus, “it’s not much of a
leap to say that failure to follow the requirement renders a label misleading
within the meaning of the FDA’s regulations.”

This all allowed Rausch’s theory of misleadingness to move
forward. Rausch also plausibly alleged that she has no adequate remedy at law,
so she may seek equitable relief at this stage in the litigation, and she had
standing to challenge the products she did not purchase because they are
“substantially similar” to the products she did purchase. But the conclusory
allegation that Flatout’s conduct was “willful and malicious” didn’t support a
claim for punitive damages; if discovery revealed information relevant to
punitive damages, Rausch could seek leave to amend.

from Blogger

This entry was posted in Uncategorized and tagged , , . Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s