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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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North Dallas Honey 6/24/13

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

June 24, 2013
 

Ref. 2013-DAL-WL-039
 

WARNING LETTER

UPS OVERNIGHT

Nathan H. Sheets
President and Owner
North Dallas Honey Company
10740 Big Horn Trail
Frisco, TX 75035

Dear Mr. Sheets:

The U.S. Food and Drug Administration (FDA) inspected your facility located at 7951 Collin McKinney Parkway, Suite 4064, McKinney, Texas from September 7, 2012 through October 9, 2012 and on January 15, 2013. During these inspections, we collected labels for your products Nature Nate's Natural 100% Pure Raw & Unfiltered Honey, Nature Nate's North Dallas Honey Co. Pure Raw & Unfiltered Honey, and Norcal Honey Co. Pure Raw & Unfiltered Honey. FDA also reviewed your website at www.naturenates.com in June 2013 and determined that your website constitutes labeling under section 201 (m) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321 (m)] because the website address either appears on your product labels, and/or is linked to the website addresses on your product labels, and your products may also be purchased from the www.naturenates.com website. Based on our review of your product labels and website, we have concluded that your products are promoted for conditions that cause them to be drugs under section 201 (g)(1)(B) of the Act [21 U.S.C. § 321 (g)(1)(B)]. The claims made in the labeling for these products establish that these products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease of the human body. The marketing of these products with these claims violates the Act. You can find the Act and FDA regulations through links at FDA's home page at http://www.fda.gov.

We received your response to the inspectional observations we discussed with you at the close of the October inspection, dated October 24, 2012, and conclude that the response does not adequately address these violations. Although the response committed to modify your product labels to remove references to allergies and other health benefits associated with your honey products, the response stated you would continue to use your current labels for approximately 8 months until your current label inventory is exhausted. In addition, the response stated your company would review your website www.naturenates.com and would ensure the material posted to this website complies with FDA regulations and your company would remove from the website all information about the effect of honey on allergies and other health-related conditions, including customer testimonials about these products. A review of your website in June 2013 revealed your website continues to make unlawful claims for your products in Spanish.

Unapproved New Drug

Examples of some of the claims observed on your product labeling include:

From your Spanish-language website under Recipes and Remedies (Recetas & Remedios) (the claims below have been translated into English):
 

• "Food Poisoning. Blend 1 Tablespoon Apple Cider Vinegar and 1 Tablespoon of North Dallas Honey dissolved in a glass of chilled water."

• "May Help with Arthritis. Recipe 1. Take 1 cup of hot water with two spoons of honey and one small teaspoon of cinnamon powder both morning and night. .. "
 

From your Spanish-language website under Commentaries (Comentarios) (the claims below have been translated into English):
 

• "'[O]rganic honey'. A client of mine that is a doctor told me to try yours for allergy relief. It has COMPLETELY eliminated allergies for the entire household ... it is our daily dose ... "
 

Your Nature Nate's Natural 100% Pure Raw & Unfiltered Honey and your Nature Nate's North Dallas Honey Co. Pure Raw & Unfiltered Honey product labels contain the following claims:
 

• "Allergy relief' [Nature Nate's North Dallas Honey Co. Pure Raw & Unfiltered Honey; Nature Nate's Natural 100% Pure Raw & Unfiltered Honey]
• "Many people are looking for the health benefits of RAW honey ... full of antioxidants, anti-bacterial, anti-fungal, vitamins, minerals and enzymes." [Nature Nate's Natural 100% Pure Raw & Unfiltered Honey]
• "We know that most of you are looking for ALLERGY RELIEF so we strain out the wax but our honey is UNFILTERED and is full of POLLEN." [Nature Nate's Natural 100% Pure Raw & Unfiltered Honey]
• "We have many testimonies of people who eat a tablespoon a day, all year, and their allergies are greatly reduced or diminished." [Nature Nate's Natural 100% Pure Raw & Unfiltered Honey] 

Your Nature Nate's Natural 100% Pure Raw & Unfiltered Honey, Nature Nate's North Dallas Honey Co. Pure Raw & Unfiltered Honey and Norcal Honey Co. Pure Raw & Unfiltered Honey products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 201 (p) of the Act [21 U.S.C. § 321 (p)]. New drugs may not be legally marketed in the U. S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

Misbranded Food

Even if your products did not have these therapeutic claims, which make them drugs, your Nature Nate's Natural 100% Pure Raw & Unfiltered Honey, Nature Nate's North Dallas Honey Co. Pure Raw & Unfiltered Honey and Norcal Honey Co. Pure Raw & Unfiltered Honey products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because their labeling bears nutrient content claims but does not meet the requirements to make the 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 in 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, your firm's Spanish website makes the following nutrient content claim characterizing the level of antioxidants in your products [the language below has been translated from Spanish to English]:
 

• From the webpage under "GET TO KNOW NATE"·· "NATE'S STORY"·· "OUR PASSION AND PURPOSE": "[H]oney that's high in naturally powerful vitamins, minerals, antioxidants .... " 

Nutrient content claims using the term "antioxidant" must comply with the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, a Reference Daily Intake (RDI) must have been established for each of the nutrients that are the subject of the claim (21 CFR 101.54(g)(1)), and these nutrients must have recognized antioxidant activity (21 CFR 101.54(g)(2)). The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54 (b), (c), or (e), (21 CFR 101.54(g)(3)). For example, to bear the claim "high in antioxidant vitamin C," the product must contain 20 percent or more of the RDI for vitamin C. Such a claim must also include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term "antioxidant" or "antioxidants" may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity (21 CFR 101.54(g)(4)). The use of a nutrient content claim that uses the term "antioxidant" but does not comply with the requirements of 21 CFR 101.54(g) misbrands a product under section 403(r)(2)(A)(i) of the Act [21 U.S.C. § 343(r)(2)(A)(i)].

The quoted claim from your website does not comply with 21 CFR 101.54(g)(4) because it does not include the names of the nutrients that are the subject of the claim or link the nutrient names to the claim by the use of a symboL The nutrient content claim of "high in ... antioxidants" also does not comply with 21 CFR 101.54(g)(3) because it fails to include the name and percentage of the Daily Value per reference amount customarily consumed for any vitamins and nutrients to substantiate the "high" nutrient claim. In order to bear the term "high," a food must contain 20 percent or more of the RDI or the DRV per reference amount customarily consumed (RACC) [21 CFR 101.54(b)(1)]. Therefore, the above quoted claim from your website does not meet the requirements of 21 CFR 101.54(g) and misbrands your products under section 403(r)(1)(A)(i) of the Act
 

Your Nature Nate's Natural 100% Pure Raw & Unfiltered Honey and your Nature Nate's North Dallas Honey Co. Pure Raw & Unfiltered Honey products are further misbranded within the meaning of section 403(r)(1)(A) of the Act because the labeling for these products bear nutrient content claims that are not authorized by regulation or fail to meet the terms of authorizing regulations. Specifically, your product labels for these products bear implied nutrient content claims as defined by 21 CFR 101.13(b)(2)(ii) because they contain statements suggesting that Nature Nate's Natural 100% Pure Raw & Unfiltered Honey, Nature Nate's North Dallas Honey Co. Pure Raw & Unfiltered Honey, and Norcal Honey Co. Pure Raw & Unfiltered Honey, because of their nutrient content, may be useful in maintaining healthy dietary practices, and those statements are made in association with claims or statements about nutrients. For example, your product labels contain the following implied nutrient content claims:
 

• "Many people are looking for the health benefits of RAW honey ... full of antioxidants ... vitamins, minerals and enzymes" [Nature Nate's Natural 100% Pure Raw & Unfiltered Honey]
• "(L]ove its health benefits ... honey is loaded with antioxidants ... vitamins ... minerals ... " [Nature Nate's North Dallas Honey Co. Pure Raw & Unfiltered Honey]
 

However, these products do not meet the requirements for use of the term "health" as set forth in 21 CFR 101.65(d)(2). To make an implied nutrient content claim using the term "healthy" or related terms (e.g., "health," "healthful," "healthfully," "healthfulness," "healthier," "healthiest," "healthily," and "healthiness"), you must comply with the requirements listed in 21 CFR 101.65(d)(2), including the requirement that your products contain at least 10% of the Daily Value per RACC of one or more of the following nutrients: vitamin A, vitamin C, calcium, iron, protein, or fiber [21 CFR 1 01.65(d)(2)(i)]. Your Nature Nate's Natural 100% Pure Raw & Unfiltered Honey, Nature Nate's North Dallas Honey Co. Pure Raw & Unfiltered Honey and Norcal Honey Co. Pure Raw & Unfiltered Honey product labels bear implied nutrient content claims containing the term "health" but, based on information available to FDA about honey, including the USDA National Nutrient Database, FDA has determined that they do not contain at least 10% of the Daily Value per RACC of one or more of the following nutrients: vitamin A, vitamin C, calcium, iron, protein, or fiber. In addition, because you fail to include the name and percentage of the Daily Value per RACC for any vitamins and nutrients in the labeling of your products, FDA cannot rely on that information to evaluate the nutrient content of your products.

Your Nature Nate's 100% North Dallas Honey Co. Pure Raw & Unfiltered Honey product is further misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because your firm is not currently exempt from the nutrition labeling requirements under section 403(q)(5)(D) of the Act [21 U.S.C. § 343(q)(5)(D)] and the product label does not contain any of the required Nutrition Facts information as required by 21 CFR Part 101.9. Further guidance and information on food labeling can be accessed on FDA's website at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorvlnformation/LabelingNutrition/FoodlabelingGuide/ucm2006828.htm.
 

The violations cited in this letter are not intended to be an all-inclusive list of violations in your products, labels and labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your Spanish-language website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
 

You should take prompt measures to correct all violations described in this letter and prevent their recurrence. Failure to take appropriate corrective action may subject your firm and products to further regulatory actions, such as injunction and/or seizure.
 

In addition to the above violations, we also have the following comment:
 

• The Nutrition Facts panels on the labels for your Nature Nate's Natural 100% Pure Raw & Unfiltered Honey and Norcal Honey Co. Pure Raw & Unfiltered Honey products are not set off within a box contained by hairlines, as required by 21 CFR 101.9(d)(1)(i). 

Within fifteen working days from your receipt of this letter, please notify this office in writing as to the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct the remaining violations.
 

Your written response to this letter should be sent to Rose Ashley, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Dallas, TX, 75204. If you have questions regarding any issues in this letter, please contact Ms. Ashley at (210) 308-1407.
 

Sincerely,
/S/

Reynaldo R. Rodriguez, Jr.
Dallas District director