Inspections, Compliance, Enforcement, and Criminal Investigations

Wonder Natural Foods Corp. 7/13/15

  

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

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

 

July 13, 2015
 
WARNING LETTER
 
 
VIA OVERNIGHT MAIL
 
Mr. Stuart Lasdon, Owner
Wonder Natural Foods Corp.
30 Blank Ln
Watermill, NY 11976
 
Re: 460929
 
Dear Mr. Lasdon,
 
The Food and Drug Administration (FDA) reviewed the labels for your Better’n Peanut Butter Original (16 oz.) product in February 2015. The label for this product directs the consumer to your website at the Internet address www.betternpeanutbutter.com. We examined your website in June of 2015. Based on our review, we have concluded that this product is misbranded within the meaning 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 Better’n Peanut Butter Original (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 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,
 
    1. Your website at www.betternpeanutbutter.com/index.php 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 labeling of your Better’n Peanut Butter Original (16 oz.) product on your website bears the claim “healthy” in connection with the statement “low fat, low calorie;”; however, the product does not meet the requirements for use of a “healthy” nutrient content claim that are set forth in 21 CFR 101.65(d)(2). In accordance with 21 CFR 101.65(d)(2)(i)(F), you may use the term “healthy” 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 RDI or the DRV per Reference Amount Customarily Consumed (RACC) for one or more of vitamin A, vitamin C, calcium, iron, protein, or fiber. According to the Nutrition Facts panel, your Better’n Peanut Butter Original (16 oz) product does not contain at least 10 percent of the RDI or the DRV per RACC for any of these nutrients. 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.
    1. Your website at www.betternpeanutbutter.com/index.php bears the nutrient content claim “low calorie;”; however, the product does not meet the requirements to bear the claim because it provides more than 40 calories per RACC and per 50g [21 CFR 101.60(b)(2)(i)(B)].                                                                                                
    1. The label bears the nutrient content claim “No Cholesterol.” As required by 21 CFR 101.13(e)(2) and 21 CFR 101.62(d)(1)(i)(D), if the food contains less than 2 mg of cholesterol per RACC without the benefit of special processing, alteration, formulation or reformulation to lower cholesterol content, a claim about the lack of cholesterol in the food must disclose that cholesterol is not usually present in the food (e.g., “applesauce, a cholesterol-free food”). Peanut butter and peanut spread products do not contain cholesterol, and therefore the label of your product should disclose that cholesterol is not usually present in the food.
2.    Your product is misbranded within the meaning of section 403(i)(1) of the Act in that “Better’n Peanut Butter” is not an appropriate statement of identity for a food [21 CFR 101.3(a)].
 
3.    Your product is misbranded within the meaning of 403(i)(2) of the Act in that the ingredients are not declared in accordance with 21 CFR 101.4. Ingredients must be listed by their common or usual name in descending order of predominance by weight. Specifically:
 
    1. The ingredient list declares "peanuts (as defatted peanut flour, peanut butter and natural peanut oils)." As stated above, according to the ingredient statement, this product does not appear to be made using peanuts as an ingredient. The referenced ingredient declaration is not allowed under 21 CFR 101.4(a)(1), which requires that ingredients are listed by common or usual name in descending order of predominance. Sub-ingredients of multi-component foods can be declared parenthetically under 21 CFR 101.4(b)(2). However, defatted peanut flour, peanut butter and natural peanut oils are not sub-ingredients of peanuts. The common or usual names of the ingredients actually used to make this product appear to be defatted peanut flour, peanut butter and peanut oil. Furthermore, if any of these ingredients are multi-component ingredients (e.g., peanut butter), the sub-ingredients must be declared in accordance with 21 CFR 101.4(b)(2).
    1. "Grain syrup" is not an adequate common or usual name for an ingredient.
    1. There is no provision in 21 CFR 101.4 that allows for the combined declaration of "natural colors and flavors." In fact, we note that any added color is artificially coloring a food; hence the labeling provisions under 21 CFR 101.22(k)(2).
4.    Your product is misbranded under 403(i)(1) and 403(g)(l) of the Act because it purports to be and is represented as peanut spread and peanut butter, in the labeling. The website at www.betternpeanutbutter.com/nutrition.php characterizes the product as "an all-natural, delicious peanut butter spread," and "diet peanut butter." The product does not meet the description for peanut spread or the requirements in the standard of identity for peanut butter. Peanut spread must meet certain requirements for protein content as described in 21 CFR 102.23(b)(1)(i) or (ii). Section 102.23(b)(1)(i) requires protein content of at least 24 percent by weight (if the overall biological quality of the protein contained in the product is at least 68 percent that of casein). For a 32 gram serving, the protein content would be between 7 to 8 grams. Better'n Peanut Butter lists 4 grams of protein per 32 gram serving. Section 102.23(b)(l)(ii) requires a minimum of 16.6 percent by weight of protein (if the overall biological quality of the protein contained in the product is equal to or greater than that of casein). For a 32 gram serving, this protein content would be 5 grams. The standard for peanut butter in 21 CFR 164.150 requires the food to contain at least 90 percent peanut ingredients, which are specified in 21 CFR 164.150(b). Defatted peanut flour, which appears to be the most predominant ingredient, is not an acceptable peanut ingredient under the standard.
 
The above violations are not meant to be an all-inclusive list of violations that may exist in connection with your products. 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 FDA taking regulatory action without further notice, such as seizure and/or injunction. 
 
In addition, we offer the following comments:
  • We note that the panel to the right of the principal display panel (PDP) bears the nutrient content claim “40% fewer calories.” Based on your product name, “Better’n Peanut Butter,” we understand the reference food for this claim to be peanut butter. However, as discussed above, “Better’n Peanut Butter” is not an appropriate statement of identity for a food. Be advised that for a “fewer calories” claim, the identity of the reference food must appear in immediate proximity to the most prominent such claim as required by 21 CFR 101.60(b)(4)(ii)(A).
  • We note that the PDP and the panel to the right of the PDP bear the nutrient content claim “85% less fat.” Based on your product name, “Better’n Peanut Butter,” we understand the reference food for this claim to be peanut butter. However, as discussed above, “Better’n Peanut Butter” is not an appropriate statement of identity for a food. Be advised that for a “less fat” claim, the identity of the reference food must appear in immediate proximity to the most prominent claim as required by 21 CFR 101.62(b)(4)(ii)(A). 
  • We note that your website makes the claim “no refined sugars.” The intent of your claim may not be clear to consumers and may mislead those who are seeking products that are sugar-free or contain no added sugar. We recommend that you clarify the meaning of your claim.
  • The “made with real peanuts” statement is potentially misleading to consumers because it may suggest that peanuts are directly added to the product or that you use peanuts as starting ingredients to manufacture this product. Based on the ingredient declaration, it appears that this is not the case. It appears that you are starting with processed ingredients derived from peanuts such as defatted peanut flour, peanut butter and peanut oil. Therefore, we suggest that the statement be clarified.
  • We note that the label bears the claim "No Preservatives." We note that if any ingredients such as tocopherol or sodium ascorbate are being used as preservatives, this statement would be false and cause the product to be misbranded under 403(a)(l).  
  • We note that the nutrition information is provided in a linear format. As specified in 21 CFR 101.9(j)(13)(ii), nutrition information may be provided in a tabular or linear (i.e., string) format rather than in vertical columns if the product has a total surface area available to bear labeling of less than 12 square inches, or if the product has a total surface area available to bear labeling of 40 or less square inches and the package shape or size cannot accommodate a standard vertical column or tabular display on any label panel. Nutrition information may be given in a linear fashion only if the label will not accommodate a tabular display.
  • The label uses the term "dehydrated cane juice" in the ingredient list. FDA is in the process of developing guidance on the common or usual name of this ingredient. We published a draft guidance for comment in October 2009 (http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm181491.htm), and on March 5, 2014, we reopened the comment period for this draft guidance until May 5, 2014. We intend to issue final guidance after reviewing the comments received. We recommend that you check the FDA website (www.fda.gov) regularly or sign up for email updates to keep up with the latest regulatory developments, including the issuance of that final guidance. You can subscribe to email updates from FDA's Center for Food Safety and Applied Nutrition (CFSAN) at https://public.govdelivery.com/accounts?USFDA/subscriber/new?topic_id=USFDA_26.
  • The information panel contains intervening material in the ingredients list such as the words "pure" and "natural" preceding the words "water" and "peanut oils."
  • The street address must be included as part of the place of business unless it is shown in a current city directory or telephone directory [21 CFR 101.5(d)].
  • We note that the nutrition and ingredient information provided on the website (www.betternpeanutbutter.com/nutrition.php) for "Regular Creamy" differs from the information provided on your "Original" label. For example, on the website, the calories from fat are declared as 18 and the ingredient list includes rice syrup, soy flour, tapioca starch, paprika & annatto, and vitamins E & C (antioxidants). Alternatively, on your product label, the calories from fat is declared as 20 and the ingredient list includes peanut oil, grain syrup, natural colors, tocopherol (vitamin E) and sodium ascorbate (vitamin C). If this is the same product, we recommend that you revise any errors that appear on the label or labeling so that the information is consistent and accurate.
  • The nutrition information on the website is missing declarations of trans fat, polyunsaturated fatty acids, monounsaturated fatty acids, and cholesterol amounts [21 CFR 101.9(c)(2) and (3)]. Dietary fiber is not declared in the appropriate order or indented [21 CFR 101.9(c)].
 
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 New York District

 

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