Recipient: Hampton Creek Foods United States Issuing Office: Center for Food Safety and Applied Nutrition United States

Department of Health and Human Services Public Health Service

Food and Drug Administration College Park, MD 20740

WARNING LETTER

AUG 12, 2015

VIA OVERNIGHT MAIL

Mr. Joshua Tetrick, Founder and Chief Executive Officer

Hampton Creek Foods, Inc.

371 Tenth Street

San Francisco, CA 94193

Re: 470327

Dear Mr. Tetrick,

The U.S. Food and Drug Administration (FDA) reviewed the labels and website labeling for your Just Mayo and Just Mayo Sriracha products in June, 2015. The label for these products directs the consumer to your website at the Internet address www.hamptoncreek.com . We examined your website in June, 2015. Based on our review, we have concluded 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). You can find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov

The significant violations are as follows:

1. Your Just Mayo and Just Mayo Siracha products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling for these products bears nutrient content claims, but the products do not meet the requirements to make such claims.

Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient on the food labeling of a product without complying with the specific requirements pertaining to the nutrient content claim for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. Specifically, the “cholesterol free” claim on your regular Just Mayo product label does not meet the requirements for a cholesterol free claim in accordance with 21 CFR 101.62(d). Additionally, your website, www.hamptoncreek.com, includes the statement “You’ll never find cholesterol in our products” (in reference to all of your products, including your Just Mayo and Just Mayo Siracha products), which is an unauthorized synonym for “cholesterol free.” However, even if the claim where an authorized synonym for “cholesterol free,” the claim does not meet the requirements for a cholesterol free claim in accordance with 21 CFR 101.62(d) when referring to your Just Mayo and Just Mayo Siracha products.

In accordance with the requirements in 21 CFR 101.62(d)(ii)(D), if the reference amount customarily consumed (RACC) is small (30 grams or less or 2 tablespoons or less) and the food contains more than 13 grams of total fat per 50 grams, then the label or labeling must disclose the level of total fat in a serving of the product in immediate proximity to the cholesterol claim. The RACC for your Just Mayo product and Just Mayo Siracha product is 15 grams. According to the nutrition labels for these products, both of these products contain 10 grams of total fat per 14 gram serving. Based on this, the level of total fat in 50 grams of these products is approximately 36 grams; therefore, the labeling must include a statement that discloses the level of total fat in a serving of the product in immediate proximity to the cholesterol claims. However, the label for your Just Mayo product and the labeling for you Just Mayo and Just Mayo Siracha products do not bear a statement disclosing the level of total fat in a serving of the products in immediate proximity to the claims.

2. Your Just Mayo and Just Mayo Sriracha products are misbranded within the meaning of section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] because the website labeling at www.hamptoncreek.com, which is referenced on the product labels, includes an unauthorized health claim.

Specifically, your website, www.hamptoncreek.com includes the following statements, “Your Heart Matters. When your heart is healthy, well, we’re happy. You’ll never find cholesterol in our products.” Adjacent to this statement is a heart shaped symbol with a smiling face. Together these statements and heart symbol are an implied health claim that these products can reduce the risk of heart disease due to the absence of cholesterol.

While there are authorized health claims about cholesterol and the reduced risk of heart disease [1] , these products do not qualify to make these health claims, in part, due to the amount of fat that they contain. FDA’s regulation at 21 CFR 101.14(a)(4) disqualifies foods from making health claims that contain more than 13 grams of fat per RACC; per labeled serving; or per 50 grams (if the RACC is less than 30 grams). As previously noted, your regular Just Mayo product contains 36 grams of fat per 50 grams. In addition, the Sriracha Just Mayo product also contains 36 grams of fat per 50 gram serving. Therefore, neither product qualifies to make a health claim as described under 21 CFR 101.14(a)(4).

3. Your Just Mayo and Just Mayo Sriracha 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, your 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. Additionally, the products contain additional ingredients that are not permitted by the standard of identity for mayonnaise, such as modified food starch.

4. Your Just Mayo and Just Mayo Sriracha 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. Therefore, these products do not conform to the standard for mayonnaise.

The above violations are not meant to be an all-inclusive list of violations that may exist in connection with your products or their labeling. It is your responsibility to ensure that your products comply with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.

In addition, we offer the following comments:

The statement of the place of business must include the street address unless it is shown in a current city directory or telephone directory (see 21 CFR 101.5(d)).

The nutrition labels do not meet the requirements in 21 CFR 101.9. We provide the following examples:

o The heading “Nutrition Facts” does not meet the requirements in 21 CFR 101.9(d)(2).

o The nutrition labels are not enclosed in a box as required in 21 CFR 101.9 (d)(1)(i).

o The nutrition labels do not include the full footnote required in 21 CFR 101.9(d)(9).

The information panel on the regular Just Mayo product does not meet the requirements in 21 CFR 101.2(a) because it is not placed on the part of the label immediately contiguous and to the right of the principal display panel.

You should respond in writing within 15 working days from receipt of this letter. Your response should outline the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent their recurrence. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.

You should direct your written reply to Anam Drumheller, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Ms. Drumheller via email at anam.drumheller@fda.hhs.gov

Sincerely,

/S/

William A. Correll, Jr.

Director

Office of Compliance

Center for Food Safety

and Applied Nutrition

cc: FDA San Francisco District



[1] See 21 CFR 101.75 and the FDA Modernization Act (FDAMA) health claim, “Saturated Fat, Cholesterol, and Trans Fat, and Reduced Risk of Heart Disease,” (Docket No. 2006Q-0458) at http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm073621.htm.

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