Quest Nutrition, LLC. - Company - 452841 - 08/10/2015
- Quest Nutrition, LLC. - Company
THE FOOD LAWYERS® Representing the Food and Beverage
1880 Century Park East, Suite 611
Los Angeles, California 90067
Telephone: (310) 556-0721
Facsimile: (310) 788-8923
August 10, 2015
Ms. Anam Drumheller
Food and Drug Administration Via: E-mail Attachment
Center for Food Safety and Applied Nutrition and
5100 Paint Branch Parkway U.S. Postal Service
Office of Compliance (HFS-608),
Division of Enforcement
College Park, Maryland 20740-3835
Re: Response to FDA Warning Letter
Dated July 29, 2015 [Project ID# 452841]
Dear Ms. Drumheller:
We represent Quest Nutrition (“Quest”) who has forwarded us the above referenced warning letter. We respectfully respond as follows:
“Healthy” Label Claim
Quest has created many high protein foods directed at persons interested in healthy lifestyles. One of these foods is Quest Protein Chips (the subject product) which is a new food, invented by Quest. It meets all legal requirements for “healthy” labeling under 21 CFR 101.65(d)(2)(i). It does not run afoul of 21 CFR 104.20’s proscription against “random fortification of foods,” because it is neither a food that has been fortified nor a snack food such as candy or carbonated beverage that has been fortified -- -- it in fact did not exist until Quest invented it. It is a healthy matrix of 50% dairy ingredients by weight, and less than 8% potato ingredients, that is crunchy -- a new food that meets the letter and spirit of applicable labeling law, and is properly labeled “healthy” by Quest.
We are very proud of this innovative product that delivers a high level of protein and a good source calcium in a format that is well received and familiar to consumers. The predominant source of these two essential nutrients is the milk-protein base. This food is not a run-of-the-mill potato crisp that has been fortified with milk proteins and calcium carbonate.
Furthermore, the ingredient declaration clearly presents the calcium carbonate as an insignificant ingredient that is less than 2% of the finished formula by weight. At this usage level, there is marginal elemental calcium (from calcium carbonate) to make a significant contribution to the fortification argument. The real calcium contributions come from the mineral content inherent to milk.
Our innovative formulation employs “mineral salts” to firm the milk-protein matrix. The interaction of calcium carbonate and milk proteins occurs at the blending and baking stages. A minor amount of calcium carbonate is required to optimize the gelation process with the milk protein blend. The residual calcium provides an essential nutrient for many at-risk Americans and is preferable to sodium salts that would introduce a nutrient of concern. Our formulation remarkably results in a crunchy high protein product that meets national dietary guidelines for low fat, no saturated fat, low cholesterol and 0g trans fat per serving.
We respectfully disagree with the Agency’s assessment that Quest BBQ-flavored Protein Chips do not meet the implied nutrient content claim for “healthy.” As shown in the table immediately below, the product complies with the nutrient requirements for “healthy” per labeled serving and per 30 gram reference amount and per 50 grams (when the RACC is small).
|Table 1: Quest BBQ Flavored Protein Chips meet definition of 'healthy'||If calculated value satisfies these levels, then product meets claim for "healthy"||Per labeled serving (32g)||per RACC (30g)||per 50g|
|Total fat (g)||≤ 3||2||1.8||2.9|
|Saturated fat (g)||≤ 1||0||0.4||0.7|
|Calories from sat fat||< 15%="" of="">||0||0.0||0.0|
|Cholesterol (mg)||≤ 60||10||9.4||15.6|
|Sodium (mg)||≤ 480||150||140.6||234.4|
|Protein (g)||≥ 5g||21||19.7||32.8|
|Calcium (mg)||≥ 10% DV||140||131.3||218.8|
As discussed in the first page of this letter, the product is predominantly a protein-matrix delivery system. Dried potatoes and corn starch are secondary ingredients that facilitate the sheeting process. They contribute negligible nutrients compared to the milk-based ingredients as evidenced by the quantity of total carbohydrates per serving. Since the product is 50% dairy ingredients by weight and less than 8% potato, it could never be considered a potato chip or a potato crisp under applicable law or any other basis. Also, unlike starch-based snacks that provide upwards of 13-18 grams total carbohydrates per RACC, this product provides just 5 grams per bag. Consequently, we do not believe 21 CFR 104.20 applies to this product because it is not a product like traditional potato chips or crackers that has been fortified to achieve some nutrient level while diluted in vegetable oils.
Thirty-two grams of Quest Protein Chips delivers an astounding 21 grams of protein (65.6% by weight), 10 mg cholesterol and 2 grams total fat. By contrast, 32 grams of cheddar cheese -- -- also a concentrated source of milk-derived protein and calcium -- -- packs in five times as much total fat and more than three times as much cholesterol compared to Quest Protein Chips, while delivering only 8 grams protein.
The RACC 85 gram amount of boneless cooked steak delivers 19 grams protein (comparable to Quest Protein Chip’s 21 grams protein) while containing six times the cholesterol (60 mg) and ten times the total fat (21 g) compared to Quest Protein Chips. We believe that Quest’s novel food product is a protein source comparable to cheddar cheese and steak. Quest Protein Chips were created with the competitive body builder, athlete and health conscious person in mind and anyone else who eats them will get the same benefit. We feel it is correctly labeled “healthy” from a public policy standpoint as well as due to its technical conformity with law.
For the reasons stated above, we do not believe the product is mislabeled respecting its “healthy” claim. As a matter of public policy, we believe the Agency should encourage innovation and marketing of new products that are healthful, pleasurable, and advance the Agency’s purpose of protecting and promoting American’s health.
We believe a “healthy” claim respecting this product meets the letter and spirit of the Food Drug & Cosmetic Act. Quest Protein Chips advance the government’s public purpose of encouraging sensible and conscientious eating derived from a wide variety of foods. Permitting this “healthy” claim allows our product to distinguish itself from traditional, fat-laden snacks and advance the government’s policies concerning responsible public dietary choices.
We ask FDA to consider the new information respectfully submitted above and advise us whether the Agency feels this product is misbranded in light thereof.
Declaration of “only” before “5g total carbs”
We appreciate and are respectful of the Agency’s comment regarding the implied nutrient content claims for total carbohydrates. While we feel that 5 grams of total carbohydrates in this product is a remarkable achievement in light of its other nutrient contributions, we are mindful of FDA’s requirements in this regard. We will change the label to remove the word “only” from the sentence that previously read, “With
only 5g of total carbs and a whopping 21g protein per bag, ….” We will provide you with a final drawing of our corrective labeling within 5 business days of the date of this letter to you. It would take the company about 12 weeks to acquire replacement packaging film and begin to fill it.
The company currently has about 180 days of packaging film in inventory. We therefore request 180 days within which to use up existing packaging and before we begin filling the corrected packaging film. We do not believe the word “only,” poses any risk to the public in this context and we beg FDA’s indulgence in this regard.
Our firm will ensure that the error regarding “only” will not be repeated because our firm will advise Quest now and in the future of its obligations regarding the word “only” as respects carbohydrate claims.
Request for Publication on FDA Website
We request that this responsive letter be published on the FDA website together with FDA’s warning letter pursuant to the rights granted the respondent under FDA Regulatory Procedures Manual §4-1-8-2. Requests To Post Response On Internet. We are providing our response to you in PDF and MS Word electronic formats as required by the Procedures Manual provisions respecting posting of responsive letters.
We appreciate your notification and the opportunity to provide clarification about our product formulation. Quest offers innovative foods that complement public health education messages for selecting healthful foods at various eating occasions. We feel public nutrition education can be augmented by the use of innovative food products that take universally accepted healthful ingredients (milk proteins) and fashion them into a familiar form that is healthful, organoleptically satisfying and well received by the public. We think Quest’s Protein Chips embody the best of this philosophy and we look forward to your guidance in view of the information provided hereinabove.
THE FOOD LAWYERS®
George C. Salmas