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Quest Nutrition, LLC. MARCS-CMS 452841 —

Delivery Method:
UPS

Recipient:
Recipient Name
David Ritterbush
Quest Nutrition, LLC.

2233 E. El Segundo Blvd.

El Segundo, CA 90245
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

 

WARNING LETTER
 
July 29, 2015 
 
VIA OVERNIGHT MAIL
 
Mike Osborn, CFO
Quest Nutrition, LLC
Corporate Office
2233 E. El Segundo Blvd.
El Segundo, California 90245
 
 
Re: 452841
 
Dear Mr. Osborn,
 
The Food and Drug Administration (FDA) reviewed the labels for your Quest Protein Chips BBQ Flavor, 1 1/8 oz product in June, 2015. Based on our review, we have concluded that this product is 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 Quest Protein Chips BBQ Flavor, 1 1/8 oz product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label and labeling bear nutrient content claims, but the product does 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,
 
a.    Your label bears an implied nutrient content claim because it bears a statement suggesting that the product may be useful in maintaining healthy dietary practices, and that statement is made in connection with a claim or statement about a nutrient. The label of your Quest Protein Chips BBQ Flavor, 1 1/8 oz product bears the claim “Quest has finally made delicious crispy chips healthy” and “Baking alone doesn’t make it healthy” in connection with the statement “a whopping 21g of protein per bag.”; However, the product does not meet the requirements for use of a “healthy” nutrient content claim set forth in 21 CFR 101.65(d)(2).
 
In accordance with 21 CFR 101.65(d)(2)(i), you may use the term "healthy" or "healthful" as an implied nutrient content claim on the label or in the labeling of certain foods provided that the food, among other things, contains at least 10% of the Recommended Daily Intake (RDI) or the Dietary Reference Values (DRV) per Reference Amount Customarily Consumed (RACC) for one or more of vitamin A, vitamin C, calcium, iron, protein, or fiber. Additionally, in accordance with 21 CFR 101.65(d)(2)(iv), if the nutrient is added to the food to meet the 10% requirement, that addition must be in accordance with the fortification policy for foods in 21 CFR 104.20.
 
According to the Nutrition Facts panel, your Quest Protein Chips BBQ Flavor, 1 1/8 oz product, which is fortified with a protein blend (milk protein isolate, whey protein isolate) and calcium carbonate to contribute protein and calcium to the product, contains 42% of the Daily Value (DV) for protein and 15% of the DV for calcium per serving. The fortification of snack foods such as potato chips is not consistent with the fortification policy in 21 CFR 104.20. Accordingly, your product does not meet the requirements for use of a "healthy" nutrient content claim on a food label [21 CFR 101.65(d)(2)]. Your product is thus misbranded within the meaning of section 403(r)(1)(A) of the Act. 
 
b. The label bears the nutrient content claim "With only 5g of total carbs." This claim is a nutrient content claim because the term "only" implicitly characterizes the level of total carbohydrate in the food. FDA has not defined nutrient content claims for carbohydrates; therefore, the use of this claim misbrands your product under section 403(r)(1)(A) of the Act. Note that under 21 CFR 101.13(i)(3), a statement about the amount or percentage of a nutrient may be made if the statement does not in any way implicitly characterize the level of the nutrient in the food and it is not false or misleading.
 
The above violations are not meant to be an all-inclusive notice 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 these and similar violations. Failure to promptly correct the violation may result in regulatory action without further notice, including seizure and/or injunction. 
 
Please respond to this letter within 15 working days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violation and prevent similar violations. 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 Carrie Lawlor, 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. Lawlor via email at carrie.lawlor@fda.hhs.gov.                        
 
Sincerely,
/S/
 
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
      and Applied Nutrition
 
 
cc: FDA Los Angeles District


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