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WARNING LETTER

Bragg Live Food Mar 04, 2015

Bragg Live Food - 03/04/2015


Recipient:
Bragg Live Food


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
 
MAR 4, 2015
 
VIA OVERNIGHT DELIVERY
 
 
Ms. Patricia Bragg, President
Bragg Live Food Products, Inc.
199 Winchester Canyon Road
Goleta, CA 93117-1961
 
Re: 433654
 
Dear Ms. Bragg:
 
The Food and Drug Administration (FDA) reviewed the label for your Bragg Healthy Vinaigrette product. The label for that product directs the consumer to your website at the Internet address www.bragg.com by listing the website on the product label, and the product may be purchased at that site. We examined the product label in July 2014 and your website in December 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 on FDA’s home page at http://www.fda.gov.
 
Your Bragg Healthy Vinaigrette 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 bears nutrient content claims, but the product does not meet the requirements to make such 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 Bragg Healthy Vinaigrette product bears an implied nutrient content claim because it bears a statement 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. The label of your Bragg Healthy Vinaigrette product bears the claim “healthy” and “health.” Specifically, the name of the product is “Bragg Healthy Vinaigrette,” and the label also bears the claim “[s]erving health worldwide since 1912.” The claims are made in connection with the statements “Contains No Added Salt” and “Contains No Trans Fat.” In addition, your website bears the following claims: “healthy vinaigrette” and “[o]ur unique taste brings you a healthy alternative with all the best of the Bragg tradition of healthy eating and living.” The website claims are made in connection with the statement “Contains no added salt, trans fat….” However, this product does not meet the requirements for use of the nutrient content claim “healthy” or “health” 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” or “health” 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), among other requirements).
 
According to your nutrition facts panel, this product contains 1.5 g of saturated fat per 2 Tablespoon (30 g) serving of the food. This amount exceeds the maximum of 1 g of saturated fat per RACC (30 g for salad dressings) of the food in the “low saturated fat” definition [21 CFR101.62(c)(2)]. Therefore, this product does not meet the requirements for the use of the nutrient content claim “healthy” or “health” on a food label or labeling. Your product is thus misbranded within the meaning of section 403(r)(1)(A) of the Act.
 
In accordance with 21 CFR 101.61(a), a claim about the level of sodium or salt in a food may only be made on the label or labeling of a food if, among other requirements, the claim uses one of the terms defined in 21 CFR 101.61 in accordance with the definition for that term. Under 21 CFR 101.61(c)(2), the term “no salt added” may be used on a label of a food if (i) no salt is added during processing; (ii) the food that it resembles and for which it substitutes is normally processed with salt; and (iii) if the food is not sodium free, the label bears the statement “not a sodium free food” or “not for control of sodium in the diet” in a specified location on your product label. Your Bragg Healthy Vinaigrette product label bears the claim “No Added Salt.” In the context of the label, the phrase “No Added Salt” is a synonym for a “no salt added” nutrient content claim. However, the food does not meet the criteria under 21 CFR 101.61(c)(2)(iii) because the nutrition facts panel states that the product contains sodium, but the label fails to bear one of the statements specified under 21 CFR 101.61(c)(2)(iii). That is, the label fails to bear either the statement “not a sodium free food” or the statement “not for control of sodium in the diet.” Your product is thus misbranded within the meaning of section 403(r)(1)(A) of the Act.
 
We note that there are alternative ways to convey the amount of sodium or salt 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 want to seek authorization to use your current claim, you may submit a petition requesting FDA toauthorize the claim (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.  
 
In addition, your Bragg Healthy Vinaigrette product is misbranded within the meaning of section 403(q)(2)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the nutrition label for this product does not include the amounts of polyunsaturated and monounsaturated fats present in the product, as required by 21 CFR 101.9(c)(2)(iii) and (iv) when claims about fatty acids are made. Since your product label bears the claim “Contains No Trans Fat,” which is a fatty acid, the label must also declare the amounts of polyunsaturated and monounsaturated fats present in your vinaigrette.
 
The above violations are not intended 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 are in compliance 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, such as seizure and/or injunction. 
 
In addition to the above violations, we also have the following comments:
  • Your product bears the claim “No Additives[.]” To the extent that this claim means that your Bragg Healthy Vinaigrette product contains no added substances, we note that the list of ingredients on your product label indicates that the product is composed of more than one ingredient, and therefore that the product contains added substances. To the extent that this claim means that the product does not contain any food additives as that term is defined in section 201(s) of the Act [21 U.S.C. 321(s)], we note that the product contains the ingredient xanthan gum which is approved by FDA as a food additive under 21 CFR 172.695. Under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)], the use of false or misleading labeling causes a food to be misbranded.
  • The statement for the place of business does not include the street address in accordance with 21 CFR 101.5(d). We note that the street address may be omitted if it is shown in a current city directory or telephone directory.
  • Your Healthy Vinaigrettebears the claim“Contains No Trans Fat,” and we note that your ingredient statement does not include a partially hydrogenated oil as an ingredient in the ingredient statement. Under section 403(r)(1)(A) of the Act, a nutrient content claim in food labeling must be made in accordance with a regulation authorizing the use of the claim in order for the food bearing such claim not to be misbranded. Although FDA has not defined the term “Contains No Trans Fat” by regulation, we announced in the Federal Register dated July 11, 2003 (68 FR 41507 at 41509) that we would likely consider exercising enforcement discretion for a trans-fat nutrient content claim that is demonstrably true, balanced, adequately substantiated, and not misleading. Under 21 CFR 101.13(h), if a food bears a nutrient content claim and also contains more than 13.0 grams of fat, 4.0 grams of saturated fat, 60 milligrams cholesterol, and 480 milligrams of sodium per reference amount customarily consumed (RACC), per labeled serving (or for a food with a RACC of 30 grams or less or 2 tablespoons or less, per 50 grams), then the food must bear a statement disclosing that the nutrient exceeding the specified level is present in the food as follows: “See nutrition information for ______content” with the blank filled in with the identity of the nutrient exceeding the specified level. Your Healthy Vinaigrette contains 15 g of fat per 50g but does not contain the disclosure statement “See nutrition information for fatcontent.” We intend to consider the exercise of our enforcement discretion for the use of the “Contains No Trans Fat” claim on your Healthy Vinaigrette provided the claim includes a disclosure statement, in accordance with the requirements in 21 CFR 101.13(h). We will review such claims on a case-by-case basis.
 
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 violations 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

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