| Public Health Service Food and Drug Administration |
| Atlanta District OffIce 60 Eighth Street N.E. Atlanta, GA 30309 |
Department of Health and Human ServicesJuly 15, 2011
VIA UNITED PARCEL SERVICE
James Alex Hardy, President
Hardy Farms Peanuts
1659 Eastman Highway
Hawkinsville, GA 31036
WARNING LETTER
(11-ATL-15)
Dear Mr. Hardy:
On May 9, 2011, U. S. Food and Drug Administration (FDA) investigators inspected your food manufacturing facility located at 1659 Eastman Highway in Hawkinsville, Georgia. Your firm manufactures products under the Hardy Farms Peanuts label. During the inspection, our investigators collected labels for your Boiled Peanuts and Hot n’ Spicy Boiled Peanuts. FDA’s review of these labels found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You may find the Act and its implementing regulations through links in FDA’s home page at http://www.fda.gov.
Unapproved New Drug
Based on a claim made on your Boiled Peanuts and Hot n’ Spicy Boiled Peanuts products’ labels, we have determined that your products are promoted for conditions that cause them to be drugs because they are intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Boiled Peanuts and Hot n’ Spicy Boiled Peanuts products bear the following claim on their respective labels under the heading “Boiled Peanut Health Benefits”:
• “Shown to lower bad LDL cholesterol while keeping good HDL cholesterol steady.”
This claim indicates that your Boiled Peanuts and Hot n’ Spicy Boiled Peanuts products are intended for use in the treatment, mitigation, and prevention of coronary heart disease through lowering "bad" (LDL) cholesterol, and maintaining HDL cholesterol steady, thereby lowering total cholesterol. Elevated levels of total and LDL cholesterol are a risk factor for coronary heart disease and can be a sign of coronary heart disease. Because of this intended use, the product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)].
Your products are new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for the above referenced use. 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.
Furthermore, your Boiled Peanuts and Hot n’ Spicy Boiled Peanuts are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because the products are offered for a condition that is not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, therefore, adequate directions cannot be written so that a layperson can use the products safely for their intended uses. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
Misbranded Food
Even if your Boiled Peanuts and Hot n’ Spicy Boiled Peanuts products were foods, FDA has determined that they are misbranded within the meaning of Section 403(r) of the Act [21 U.S.C. § 343(r)]. The introduction of a misbranded food into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
1. The following unauthorized health claim was observed on labels of your Boiled Peanuts and Hot n’ Spicy Boiled Peanuts products: “Studies show one serving of peanuts a day can cut the risk of heart disease by ½ and diabetes by ¼.”
This claim causes your products to be misbranded under section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] in that it is a health claim that has not been authorized by regulation or the Act. In a letter issued to industry on July 14, 2003, (FDA Docket Number 2002P-0505), FDA articulated one qualified health claim for certain nuts and nut-containing products for which FDA intended to consider exercising enforcement discretion:
• "Scientific evidence suggests but does not prove that eating 1.5 ounces per day of most nuts [such as name of specific nut,] as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease. [See nutrition information for fat content.]"
In the above claim, use of the bracketed phrase that refers to the name of a specific nut is optional. The bracketed disclosure statement about fat content is applicable to "whole or chopped nuts," which includes whole or chopped nuts that are raw, blanched, roasted, salted, and/or lightly coated and/or flavored, but any fat or carbohydrate added in the coating or flavoring of a whole or chopped nut should meet the definition of an insignificant amount in 21 CFR 101.9(f)(1). When applicable, this disclosure statement is to be placed immediately adjacent to and directly beneath the claim, with no intervening material and no brackets, in the same size, typeface, and contrast as the claim itself (See 21 CFR 101.14(e)(3) and 101.13(h)). Types of nuts eligible for this claim are restricted to almonds, hazelnuts, peanuts, pecans, some pine nuts, pistachio nuts, and walnuts.
The claim presented on your products’ labels is not consistent with this qualified health claim. A summary of qualified health claims subject to enforcement discretion, including more detailed information on the qualified health claim for nuts and heart disease may be found on FDA’s website at http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm073992.htm.
Additional guidance on FDA’s food labeling requirements generally may be found on FDA’s website at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm.
2. Your Boiled Peanuts and Hot n’ Spicy Boiled Peanuts products bear the claim, “Four times more antioxidants than raw or roasted peanuts.” Pursuant to 21 CFR 101.54(g)(3), a nutrient content claim that characterizes the level of antioxidant nutrients present in a food may be used on the label of that food when the level of each nutrient is sufficient to qualify for the claim in other subsections of 21 CFR 101.54. Subsection 101.54(e)(1)(iii)(B) states that a relative claim including “more” may be used on the label of foods provided that quantitative information comparing the level of the nutrient in the product per labeled serving with that of the reference food that it replaces is declared adjacent to the most prominent claim or to the nutrition label. However, the labels for your Boiled Peanuts and Hot n’ Spicy Boiled Peanuts products contain no quantitative information regarding antioxidants in either your products or the reference foods.
In addition, pursuant to 21 CFR 101.54(g)(4), a nutrient content claim that characterizes the level of antioxidant nutrients present in a food may be used on the label or in the labeling of that food when either the names of the nutrients that are the subject of the claim are included as part of the claim or when used as part of a nutrient content claim, the term “antioxidant” or “antioxidants” is linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of a product label followed by the name or names of the nutrients with recognized antioxidant activity. However, the labels for your Boiled Peanuts and Hot n’ Spicy Boiled Peanuts products fail to identify the names of the nutrients that are subject of the claim that your products have “Four times more antioxidants than raw or roasted peanuts.”
Therefore, your products are misbranded within the meaning of Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims that are not authorized by regulation or fail to meet the terms of authorizing regulations.
This letter is not intended to be an all-inclusive statement of your labeling violations. You are responsible for ensuring that your firm is operating in compliance with all the requirements of the Act and pertinent FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly and adequately correct these labeling violations may result in FDA initiation of regulatory actions including, but not limited to, seizure of your products or injunction.
We also note that both your Boiled Peanuts and Hot n’ Spicy Boiled Peanuts products declare “0%”for both trans fat and sugars in the “% Daily Value” column of their nutrition fact panels. There is no established daily reference value for either trans fat or sugar, therefore, a % Daily Value should not be declared for either.
Additional information on trans fat labeling requirements may be found on the FDA website at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm053479.htm.
Within 15 working days of receipt of this letter, please notify this office in writing of the specific actions you intend to take to correct these labeling violations and included copies of related documentation of your corrections, which may include copies of updated labeling. If you are unable to complete corrective actions within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
Your written response should be sent to the U. S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer, at the address noted in the letterhead. If you have any questions, please contact Mrs. Morton at 404-253-1285 or write her at the noted address.
Sincerely,
/s/
John Gridley, Director
Atlanta District Office
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