“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.”

Thank God it’s Friday! Quick news from the food world (Week 45)

Here’s my article selection of the week:

EU

– Environment Committee backs flexibility for EU countries to ban GMO crops, from European Parliament ENVI Committee: long-awaited draft plans to allow EU member states to restrict, or ban, the cultivation of crops containing genetically modified organisms on their own territory even if it is allowed at EU level won the support of the Environment Committee on Tuesday. MEPs voted to remove the Council-backed idea of a phase of negotiations with the GMO company, and supported plans to allow member states to ban GMO crops on environmental grounds.

– Italy cracks whip on health claim abusers – fines could reach €5m, by Shane Starling+, on Nutraingredients: regulators in Italy’s €1.2bn food supplements market are cracking the harshest whips against health claims abusers in the EU – a firm was recently fined €250,000 – but will the wounds be deep enough to change the market?

 Fears that German avian flu outbreak could spread, by Ed Bedington, on Globalmeatnews.com: animal health experts are continuing to monitor the outbreak of highly pathogenic avian influenza H5N8 in Germany as the yearly migration of wild birds continues to cause concerns the condition might spread.

CHINA

– China Health Food: New Regulations on Nutritional Supplements, by Rachel Shen, on Chemlinked.com: on Nov. 5, 2014, CFDA released the draft of Administrative Provisions on Nutritional Supplements and Requirements on Dossiers for Nutritional Supplements, which gives detailed instructions on regulatory requirements for nutritional supplements in China. The period for public consultation is until Nov. 30, 2014.

NUTRITION

– Mediterranean diet has ‘lasting’ health benefits, say researchers, by Nathan Gray+, on Nutraingredients.com: the health benefits of switching to a Mediterranean style diet and upping the amount of time spent exercising for a period of just eight weeks can still be seen a year after stopping the regime, according to a new study.

USA

– Food Fraud: Money Scam and Health Hazard, by Beth Krietsch, on Foodsafetynews: despite the common belief that food fraud in the United States is a rarity, the globalized nature of our food supply chain means many of our favorite foods and ingredients travel far and wide before they reach our plates, making adulteration and other types of food fraud a considerate problem here as well.

– New App Shows Health Inspection Records for Nearby Restaurants, by James Andrews, on Foodsafetynews.com.

– Revised FSMA Provisions Need More Tweaks, by Lydia Zuraw, on Foodsafetynews.com: the public is generally pleased with the revised provisions of four rules under the Food Safety Modernization Act (FSMA), but the public comments at the Food and Drug Administration’s public meeting Thursday suggest that the agency may have more tweaking to do.

– Unilever: “Just Mayo” Misleads Consumers Because It’s Not “Mayo”, by David Ter Molen, on FoodIdentityblog.com: on October 31, 2014, Unilever filed suit in the U.S. District Court in New Jersey against Hampton Creek, Inc. for false advertising and unfair competition for selling an egg-free spread under the brand name “Just Mayo.” According to Unilever, the lack of any eggs in the product precludes it from being labeled as “mayonnaise” under federal regulations and consumers are further misled in this regard by the egg on the product label.