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WARNING LETTER

Premier Organics Inc. MARCS-CMS 431656 — Aug 12, 2014

Premier Organics Inc. - 431656 - 08/12/2014


Recipient:
Premier Organics Inc.


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 

 AUG 12, 2014

WARNING LETTER
 
 
VIA EXPRESS DELIVERY
 
Santiago Cuenca-Romero, President
Premier Organics Inc.
810 81st Avenue
Suite B
Oakland, CA 94621
 
Re: 431656
 
Dear Mr. Cuenca-Romero:
 
The Food and Drug Administration (FDA) has reviewed the label for your Artisana Coconut Butter Whole Coconut Flesh 16 oz. product.  The label for that product directs the consumer to your website at the Internet address www.artisanafoods.com by listing the website on the product label. We examined the product label and your website at www.artisanafoods.com in June 2014.  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 in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links in FDA’s home page at www.fda.gov.
 
Your Artisana Coconut Butter Whole Coconut Flesh 16 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 do not meet the requirements to make the claims.
 
Under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)], 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 nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.
 
Specifically, the label of your Artisana Coconut Butter product bears an implied nutrient content claim, because it bears statements suggesting that the product may be useful in maintaining healthy dietary practices, and those statements are made in connection with claims or statements about nutrients. Specifically, the label of your Artisana Coconut Butter product bears the claims “The Art of Healthy Foods” and “healthy…food…” in connection with the statement “preserves the life-essential fatty acids, enzymes, vitamins and minerals.” However, this product does not meet the requirements for use of the nutrient content claim “healthy” that are set forth in 21 CFR 101.65(d)(2).
 
In accordance with 21 CFR 101.65(d)(2), you may use the term “healthy” as an implied nutrient content claim on the label or in the labeling of a food provided that the food, among other things, is “low saturated fat” as defined in 21 CFR 101.62(c)(2) (i.e., the food has a saturated fat content of 1 g or less per Reference Amount Customarily Consumed (RACC) and no more than 15 percent of the calories are from saturated fat).
 
According to the Nutrition Facts panel, your product contains 16 g of saturated fat per 32 g serving of the food. This amount exceeds the maximum of 1 g of saturated fat per RACC for the food and the maximum of 15% of calories from saturated fat in the “low saturated fat” definition. Accordingly, your product does not meet the requirements for use of the nutrient content claim “healthy” 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.
 
In addition, the website labeling bears the claim: “good source of essential amino acids,” which is a nutrient content claim as defined by 21 CFR 101.13(b)(1) because it is a direct statement about the level of a nutrient in the food. FDA has issued a regulation specifying criteria for the use of the nutrient content claim “good source” in food labeling (21 CFR 101.54(c)). This regulation requires, in relevant part, that a food that bears this claim contain 10 to 19 percent of the Daily Value (DV) per RACC of the nutrient to which the term refers. However, this regulation does not authorize your claim because there is no DV for amino acids. Therefore, the use of the term “good source” to characterize the level of amino acids in your product misbrands your product under section 403(r)(1)(A) of the Act. Further, even if we determined that the term “good source of amino acids” could be synonymous with the term “good source of protein,” your claim would nevertheless not comply with the requirements of 21 CFR 101.54(c). According to the nutrition label for your product, the product contains 2 g of protein per RACC, which is 4 percent of the DV for protein. This level of protein is below the 10 to 19 percent of the DV for protein that would qualify the product for a “good source of protein” claim under 21 CFR 101.54(c). Accordingly, this product does not meet the requirements to bear a nutrient content claim for “good source” of protein.
 
We note that there are alternative ways to convey the amount of amino acids in your product to consumers. For example, the amount of a nutrient in a food may be stated on the product label or labeling in accordance with the requirements in 21 CFR 101.13(i). If you would like to seek authorization to use your current claim, you may submit a petition requesting FDA toauthorize a new nutrient content claim for amino acids (see 21 CFR 101.69). FDA’s review and authorization of a nutrient content claim prior to use in labeling ensures that the claim will provide consistent, meaningful information to consumers about the content of a product.  
 
Your Artisana Coconut Butter Whole Coconut Flesh 16 oz. product is also misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] in that the net quantity of contents statement does not meet the prominence requirements of 21 CFR 101.105(h). Specifically, the net quantity declaration is not in bold face print or type in distinct contrast to other printed matter.
 
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. Failure to promptly correct the violations may result in regulatory action without further notice, including seizure and/or injunction. 
 
Please respond to this letter within 15 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 violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete the corrective actions 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, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835. If you have any questions regarding this letter, please contact Ms. Lawlor via e-mail 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 San Francisco District
 

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