“Just Mayo” without eggs? FDA warning letter to Hampton Creek Foods

On 20th August 2015 the U.S. Food and Drug Administration published the following warning letter, after reviewing Hampton Creek Foods’ Just Mayo and Just Mayo Sriracha labels.

The FDA concludes that these products are in violation of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343] and its implementing regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). Basically, for 4 different reasons:

1-2 Health claims: the presence on the labels and on advertising materials of an unauthorised health claim (“cholesterol-free”, “Your Heart Matters. When your heart is healthy, well, we’re happy. You’ll never find cholesterol in our products.” or equivalent wordings);

3. Misbranding: products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that they purport to be the standardized food mayonnaise due to the misleading name and imagery used on the label, but do not qualify as the standardized food mayonnaise as described under 21 CFR 169.140. The name “Just Mayo” and an image of an egg are prominently featured on the labels for these products. The term “mayo” has long been used and understood as shorthand or slang for mayonnaise. The use of the term “mayo” in the product names and the image of an egg may be misleading to consumers because it may lead them to believe that the products are the standardized food, mayonnaise, which must contain eggs as described under 21 CFR 169.140(c). Additionally, the use of the term “Just” together with “Mayo” reinforces the impression that the products are real mayonnaise by suggesting that they are “all mayonnaise” or “nothing but” mayonnaise. However, Just Mayo and Just Mayo Sriracha do not meet the definition of the standard for mayonnaise. According to the labels for these products, neither product contains eggs.

4. Non compliance with the related standard of identity: products are misbranded within the meaning of section 403(g) of the Act [21 U.S.C. § 343(g)] in that they purport to be a food for which a definition and standard of identity has been prescribed by regulation, but they fail to conform to such definition and standard. Specifically, these products purport to be mayonnaise by prominently featuring the word “Mayo” on the labels, which has long been used to refer to mayonnaise. Mayonnaise is a food for which a definition and standard of identity has been prescribed by regulation (see 21 CFR 169.140). According to the standard of identity for mayonnaise, egg is a required ingredient (21 CFR 169.140(c)); however, based on the ingredient information on the labels, these products do not contain eggs. We also note that these products contain additional ingredients that are not permitted by the standard, such as modified food starch, pea protein, and beta-carotene, which may be used to impart color simulating egg yolk.

It will be extremely interesting to see how the company will react, trying to defend a really difficult position.

In October 2014 Unilever filed a lawsuit against Hampton Creek, raising more or less the same arguments. Few months later, anyway, they drop the action without any reason. Probably, they prefer to wait the enforcement action by the FDA, in light of the fact that a petition on Change.org calling on Unilever to “stop bullying sustainable food companies” gathered more than 112.000 signature in few days.

Sustainable or not (that’s completely another matter), the Hampton Creek position in my opinion is quite critical because:

  1. in US there is a standard of identity for mayonnaise and they don’t meet it;
  2. they suggest both by wording and pictorial of eggs that their products are mayonnaise;
  3. “mayo” is commonly understand all over the world as a synonym of mayonnaise and the egg is a characterizing ingredient of such a product.

Therefore, also in case you remove from the equation the standard of identity, the product could still be considered misleading.

It is interesting to stress that in EU, one of the innovation brought by the Food Information to Consumers Regulation (or “FIC”, Reg. (EU) n. 1169/2011, entered in application on 13th December 2014) considered specifically the ingredient’s substitution.

The art. 7 on Fair information practices provides that food information shall not be misleading, particularly:

“(d) by suggesting, by means of the appearance, the description or pictorial representations, the presence of a particular food or an ingredient, while in reality a component naturally present or an ingredient normally used in that food has been substituted with a different component or a different ingredient.”

Moreover, the Annex VI, point 4, establishes a positive obligation to label this kind of ingredients, with specific rules for positioning and font size:

“In the case of foods in which a component or ingredient that consumers expect to be normally used or naturally present has been substituted with a different component or ingredient, the labelling shall bear — in addition to the list of ingredients — a clear indication of the component or the ingredient that has been used for the partial or whole substitution:

(a) in close proximity to the name of the product; and

(b) using a font size which has an x-height of at least 75 % of the x-height of the name of the product and which is not smaller than the minimum font size required in Article 13(2) of this Regulation.”

FDA Warning Letter – Misbranding – Whole grain benefits and not authorised claims

Here’s the FDA position about not authorised digestive claims in USA:
FDA WARNING LETTER – MAR 10, 2015
The Food and Drug Administration (FDA or we) reviewed the label for your Post Great Grains Digestive Blend (vanilla graham) product in September 2014. Based on our review, we have concluded that your Post Great Grains Digestive Blend (vanilla graham) product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) [Title 21, United States Code (U.S.C.), sections 301 et seq.] and the applicable regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). You can find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.
Your Post Great Grains Digestive Blend (vanilla graham) product is misbranded within the meaning of section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] in that the labeling bears health claims that were not authorized by FDA.
Your product label bears claims that characterize the relationship of a nutrient to a disease or health-related condition. Specifically, your product label bears the following claims: “By consuming at least 48 g of whole grains per day you can support healthy digestion and reduce the risk of several chronic diseases like heart disease and diabetes. New Great Grains Digestive Blend cereal has 41 g of whole grain which is more than 85% of the daily recommended amount!”
A health claim expressly or by implication characterizes the relationship between a substance and a disease or health-related condition [21 CFR 101.14(a)(1)]. Substance means a specific food or component of food [21 CFR 101.14(a)(2)]. The whole grains that are a component of your product are substances within the meaning of 21 CFR 101.14(a)(2), and your label characterizes the relationship of these substances to diseases or health-related conditions (i.e., heart disease and diabetes). Because the product label bears health claims that were not authorized by FDA either by regulation [see section 403(r)(3)(A)-(B) of the Act [21 U.S.C. § 343(r)(3)(A)(B)]] or under authority of the health claim notification provision of the Act [see section 403(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(G)]], the product is misbranded within the meaning of section 403(r)(1)(B) of the Act.
FDA has authorized health claims linking the consumption of whole grain foods to reduced risk of heart disease through the notification procedure in section 403(r)(3)(C) of the Act. Of those authorized claims, the ones closest to the claims on your product label are as follows:
  • “Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol, may help reduce the risk of heart disease and certain cancers.”[1]
  • “Diets rich in whole grain foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease.”[2]
The claim “By consuming at least 48 g of whole grains per day you can… reduce the risk of several chronic diseases like heart disease…” is not consistent with either of the above-cited claims that are authorized under section 403(r)(3)(C) of the Act. For example, your claim leaves out any reference to other plant foods and to foods low in saturated fat and cholesterol.
In addition, in a September 11, 2013, letter announcing that FDA would consider the exercise of enforcement discretion[3], FDA articulated two claims for which the agency intends to consider the exercise of enforcement discretion, each of which references the “very limited scientific evidence” linking the consumption of whole grains with a reduced risk of type 2 diabetes. Those claims are as follows:
  • “Whole grains may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very limited scientific evidence for this claim.”
  • “Whole grains may reduce the risk of type 2 diabetes. FDA has concluded that there is very limited scientific evidence for this claim.”
The claim “By consuming at least 48 g of whole grains per day you can… reduce the risk of several chronic diseases like…diabetes…” is not consistent with either of the above-cited claims for which FDA announced it would consider the exercise of enforcement discretion.   For example, your claim leaves out any reference to the very limited scientific evidence linking the consumption of whole grains with a reduced risk of type 2 diabetes.
For all of the above-noted reasons, your product is misbranded within the meaning of section 403(r)(1)(B) of the Act.
If you are aware of additional evidence that would support a health claim by regulation or a qualified health claim, we encourage you to submit a petition pursuant to section 403(r)(4) of the Act [21 U.S.C. § 343(r)(4)]; see also FDA’s guidance on qualified health claims, which includes the procedures for submitting qualified health claim petitions.
(Source: FDA website)