NEWS - August 2010:
Aloe Vera Juice Manufacturer Receives Warning Letter from FDA
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NEWS - August 2010: Aloe Vera Juice Manufacturer Receives Warning Letter from FDA |
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Aloe Vera Juice Manufacturer Receives Warning Letter from FDA http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm220572.htm August 6, 2010 ~ The FDA recently issued a Warning Letter (full information can be found at the link above) to the manufacturer of the Lakewood Juice brand, Florida Bottling, Inc. The company has an aloe vera juice product, Pure Aloe, among many others, and was the subject of much of the contents of the Warning Letter and the company’s infractions. We have distilled the letter to include here the components relevant to members and have called attention to these sections in particular, adding bold type font to the most relevant text.
The FDA has informed the company that they have found the pure aloe product to be in violation of the Federal Food, Drug & Cosmetic Act for the following reasons:
Your product labels and your websites at www.lakewoodjuices.com and www.floridabottling.com, promote your juice beverage products for conditions that cause them to be drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. Pure Aloe: • Label: o "Reduce
Swelling in Joints" • Website: o "Drinking aloe vera juice can aid in the healing of ... ulcers ...." Your products are not generally recognized as safe and effective for the above referenced, uses; therefore, the products are "new drugs" under section 201(P) of the Act [21 U.S.C. § 321(P)]. This should be taken as an indication that the FDA will be more heavily scrutinizing beverage products marketed as a conventional food going forward, including aloe vera beverages, and members should keep label and marketing claims made on websites and in other materials to those that comply with federal labeling law. Structure/Function claims that are made for products marketed as conventional beverages must not make “drug” claims and are limited to the nutritive value of the product or its ingredients. We should also assume that a high level of scrutiny will also apply to aloe vera dietary supplements.
The FDA produced guidance for the labeling of dietary supplements, and can be found on the FDA website HERE. The FDA Food Labeling Guide is also available HERE. The FDA has also published food labeling guidance and other regulatory information, which can also be found on the FDA website HERE, and includes links to the following: Title 21, parts 100-199; the Federal Food, Drug and Cosmetic Act (FD&C Act), Chapter IV: Food; and the Fair Packaging and Labeling Act of 1966. The IASC has also developed labeling guidance to assist members with some aspects of regulatory compliance that can be found HERE. Unauthorized Nutrient Content Claims Nutrient content claims using the terms "high," "rich in," or "excellent source of" may be used on the label and in the labeling of foods provided that the food contains 20 percent or more of the reference daily intake (RDI) or the daily reference value (DRV) per reference amount customarily consumed (RACC) [21 CFR 101.54(b)(1)]. Therefore, claims made on the label and website for your Pure Aloe juice beverage product are unauthorized nutrient content claims because, according to the label, the product contains less than the required 20 percent RDI or DRV per RACC of the nutrient for which the claim is made. Specifically, your Pure Aloe product label and webpage bear the claim "Excellent sources of ... Fiber ...." The Nutrition Facts panel declares that a 4 fl oz serving of the product contains 8% of the Daily Value for fiber. The RACC for fruit juices is 240 mL, or 8 fl oz; therefore, this product contains only 16% of the Daily Value for fiber per RACC. Nutrient content claims using the term "antioxidant" must also 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, an 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)]. 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 403(r)(1)(A) of the Act. Therefore, the claims "Super Anti-Oxidant" and "Tremendous Source of Anti-Oxidants" for your Pure Aloe product are unauthorized nutrient content claims because the source of the antioxidant is not identified with use of the term as required in 21 CFR 101.54(g)(4).. Other Food Labeling Violations Your…Pure Aloe…juice beverage products are further misbranded within the meaning of Section 403(q)(1) of the Act [21 U.S.C. 343(q)(1)] because the nutrition facts information is not in the proper format as defined in 21 CFR 101.9. Specifically, the Pure Aloe…product labels fail to properly declare the serving size as specified by 21 CFR 101.9(b) and 101.12(b). The serving size for a fruit juice product is based on the RACC, which is 240 mL, or 8 fl oz. However, the Pure Aloe…product labels declare a serving size of 4 fl oz. Your Organic Pure Aloe juice beverage product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the percentage of fruit juice is declared in the incorrect format. Specifically, 21 CFR 101.30(e)(1) requires that the percent juice statement appear near the top of the information panel with no other printed label information appearing above the statement except the brand name, product name, logo, or universal product code. Your product label includes the statement "Contains Pure Aloe Vera Fortified & Enriched" above your percent juice statement. Your…Pure Aloe…product labels declare a percent Daily Value (% DV) for trans fat on the "Nutrition Facts" panel. A % DV for trans fat has not been established; consequently, it cannot be declared on the label. The Organic Pure Aloe product label fails to bear a common or usual name that accurately describes the basic nature of the product or its characterizing properties or ingredients [21 CFR 102.5]. Since the ingredient statement contains "organic lemon juice" and "organic lime juice," it appears to be a juice in a blend of two other fruit juices, and the common or usual name should signify that the product is a juice blend. Your Pure Aloe label does not express total calories to the nearest 5-calorie increment up to and including 50 calories, as required by 21 CFR 101.9(c)(1)]. Your product declares Total Calories as 4. Your Pure Aloe juice label does not list Vitamin A, calcium, and iron as required by 21 CFR 101.9(c)(8)(ii). Again, these comments clearly demonstrate the FDA appears to be carefully scrutinizing product labels for claims as well as for compliance with other labeling regulations. Members who manufacture juice products for sale as food are advised to apprise themselves of and comply with all applicable labeling regulations. For more information contact:
Devon Powell |