March 28, 2013
In reply refer to Warning Letter SEA 13-15
Cheryl A. Stewart, Owner
James D. Stewart, Owner
Ron T. Stewart, Owner
Stewart Brothers, Inc.
3610 Central Vale Road
Hood River, Oregon 97031
Dear Ms. Stewart and Messrs. Stewart:
On November 5-8, 2012, an investigator with the United States Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility, located at 3610 Central Vale Road, Hood River, Oregon. During our inspection, our investigator collected labels of your Columbia Gorge Organic juice drink products and we have reviewed the regulatory status of some of these products. Based on our review, your SuperBerry Fruit Juice Drink Blend is adulterated within the meaning of Section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(2)(C)] because it bears or contains an unsafe food additive. Specifically, it contains Ginkgo biloba leaf extract (Ginkgo), which is an unapproved food additive under Section 409 of the Act [21 U.S.C. § 348]. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations (CFR), Part 170.
Additionally, based on our review of your product labels and website, your Pomegranate Blueberry Cherry with Superfruits, Protein CoGo, Blueberry B'Mega. Strawberry Super C. and Super C
fruit juice drinks are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343]. You may find the Act and FDA regulations through links at FDA's Internet home page at http://www.fda.gov
Unapproved Food Additive
Any substance added to a conventional food, such as your SuperBerry Fruit Juice Drink Blend, must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)]. There is no food additive regulation that authorizes the use of Ginkgo. We are not aware of any information to indicate Ginkgo is the subject of a prior sanction [see 21 CFR 181]. As explained below, we are not aware of any basis to conclude that Ginkgo is GRAS for use in conventional foods.
FDA's regulations in 21 CFR 170.30(a)-(c) describe criteria for eligibility for classification of a food ingredient as GRAS. General recognition of safety must be based only on the views of qualified experts. The basis of such views may be either (1) scientific procedures or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. In addition, general recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food.
• Under 21 CFR 170.3(h), "[s]cientific procedures include those human, animal, analytical, and other scientific studies, whether published or unpublished, appropriate to establish the safety of a substance." Under 21 CFR 170.30(b), "[g]eneral recognition of safety based upon scientific procedures shall require the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient." Section 170.30(b) further states that general recognition of safety through scientific procedures is ordinarily based upon published studies, which may be corroborated by unpublished studies and other data and information.
• Under 21 CFR 170.3(f), "[c]ommon use in food means a substantial history of consumption of a substance for food use by a significant number of consumers." Under 21 CFR 170.30(c)(1), "[g]eneral recognition of safety through experience based on common use in food prior to January 1, 1958, shall be based solely on food use of the substance prior to January 1, 1958, and shall ordinarily be based upon generally available data and information." Importantly, however, the fact that a substance was added to food before 1958 does not, in itself, demonstrate that such use is safe, unless the pre-1958 use is sufficient to demonstrate to qualified experts that the substance is safe when added to food [21 CFR 170.30(a)].
• Under 21 CFR 170.3(i), "[s]afe or safety means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use." The regulation provides that, in determining safety, the following factors are to be considered: (1) The probable consumption of the substance and of any substance formed in or on food because of its use; (2) the cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet; and, (3) safety factors which, in the opinion of qualified experts, are generally recognized as appropriate. Such safety factors ordinarily are established through extensive testing in animals to determine whether consumption of the ingredient produces adverse effects when consumed chronically (i.e., on a daily basis over the course of a lifetime) [Guidance for Industry and Other Stakeholders: Toxicological Principles for the Safety Assessment of Food Ingredients, Redbook 2000, available at: http://www.fda.gov/Food/GuidanceComplianceRegulatorylnforrnationlGuidanceDocuments/FoodlngredientsandPackaging/Redbook/default.htm
We know of no basis for general recognition of safety for Ginkgo based either on scientific procedures or common use in food prior to January 1, 1958. In assessing the GRAS status of Ginkgo for use in conventional foods such as yours, we considered the criteria described above. FDA is not aware of data to establish the general recognition of safety of Ginkgo for use as an ingredient in conventional foods. On the contrary, reports in the scientific literature have raised safety concerns about the use of Ginkgo in conventional foods. For example, recent animal studies conducted by National Toxicology Program (NTP) showed Ginkgo to have carcinogenic activities in animals. [NTP Technical Report on the Toxicology and Carcinogenesis Studies of Ginkgo Biloba Extract, available at http://ntp.niehs.nih.gov/Ntp/About_Ntp/Trpanel/2012/February/DraftTR578.pdf
.] Therefore, the use of Ginkgo in your SuperBerry Fruit Juice Drink Blend
product does not satisfy the criteria for GRAS status under 21 CFR 170.30.
FDA is not aware of any other exemption from the food additive definition that would apply to Ginkgo for use as an ingredient in a conventional food, such as your SuperBerry fruit juice drink product. Therefore, Ginkgo added to a conventional food is a food additive under Section 201(s) of the Act [21 U.S.C. § 321(s)] and is subject to the provisions of Section 409 of the Act. Under Section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Ginkgo is not approved for use in any conventional food, including beverages. Therefore, your SuperBerry Fruit Juice Drink Blend is adulterated within the meaning of Section 402(a)(2)(C) of the Act.
The following labeling violations cause your Pomegranate Blueberry Cherry with Superfruits, Protein CoGo, Blueberry B'Mega, Strawberry Super C, and Super C fruit juice drinks to be misbranded under Section 403 of the Act [21 U.S.C. § 343]:
1. Your Pomegranate Blueberry Cherry with Superfruits Fruit Juice Drink Blend is a misbranded food under section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] because the product label bears a nutrient content claim but does not meet the requirements to make the claim. 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 promulgated by the Secretary (or by delegation, FDA) 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.
Your Pomegranate Blueberry Cherry with Superfruits Fruit Juice Drink Blend product label bears the claim "Antioxidant-rich in Plant Polyphenols & Anthocyanins." This statement is a nutrient content claim.
Nutrient content claims characterizing the level of antioxidant nutrients 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 also must be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e) [21 CFR 101.54(g)(3)]. For example, under 21 CFR 101.54(b), 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 also must include the names of the nutrients that are the subject 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 appearing 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 nutrient content claim "Antioxidant-rich in Plant Polyphenols & Anthocyanins" characterizes the level of the nutrients plant polyphenols and anthocyanins; however, no RDI has been established for these substances. In addition, this nutrient content claim is a "high" claim as defined in 21 CFR 101.54(b)(1). Therefore, this claim may be used in the labeling of a food only if the food contains 20 percent or more of the RDI or DRV per the reference amount customarily consumed. As noted above, plant polyphenols and anthocyanins do not have an established RDI or DRV; therefore a food cannot contain at least 20 percent of the RDI or DRV. Accordingly, your Pomegranate Blueberry Cherry with Superfruits Fruit Juice Drink Blend product does not meet the requirements to make such a claim, which misbrands your product within the meaning of section 403 (r)(1)(A) of the Act.
2. Your Protein CoGo 20g Soy Protein Fruit Juice Drink Blend is misbranded under section 403(r)(1)(B) of the Act [21 U.S.C. 343(r)(1)(B)] because the product labeling bears health claims that have not been authorized by regulation or the Act. The label of this product includes the Internet address of your website, www.cogojuice.com. The labeling for this product on your website bears the statement, "Diets low in saturated fat and cholesterol that include 25g of soy protein a day may reduce the risk of heart disease. One bottle (2 servings) of Protein CoGo provides 20g of soy protein." This health claim is authorized by 21 CFR 101.82. However, as set forth in 21 CFR 101.82(c)(2)(iii), only products that meet the nutrient content requirements in 21 CFR 101.62 for "low saturated fat" and "low cholesterol" food may bear this claim in their labeling. Your product does not meet the requirements for "low saturated fat" food in 21 CFR 101.62(c)(2); therefore, your product is not eligible to bear the soy protein health claim authorized by 21 CFR 101.82 and is misbranded under section 403(r)(1)(B) of the Act.
3. Your Blueberry B 'Mega, Strawberry Super C, and Super C fruit juice drinks are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients, but the labels fail to declare the common or usual name of each ingredient in the product in accordance with 21 CFR 101.4.
Specifically, your product labels list "Orgen-B's" and "Orgen-C" in the ingredient statements; however, these are not the common or usual names of any type of food ingredient. Furthermore, we note that the labels for your Blueberry B 'Mega, Strawberry Super C, and Super C fruit juice drink products include the following statements: "... Orgen-B's-a blend o" (Blueberry B 'Mega) and "Super C ... Super Combo of 4 food-based sources ... (Strawberry Super C, Super C); therefore, it appears that Orgen-B's and OrgenC are made up of more than one sub-component. You must list all sub-components of ingredients in accordance with 21 CFR 101.4(b)(2).
4. Your Protein CoGo 20g Soy Protein Fruit Juice Drink Blend is misbranded under section 403(q) of the Act [21 U.S.C. § 343(q)] because the label bears a protein claim, but the label fails to declare the % Daily Value (% DV) of protein. Under 21 CFR 101.9(c)(7)(i), the % DV must be declared if a protein claim is made for a product.
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA.
You should take prompt action to correct the adulteration and misbranding violations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products.
In addition to the violations discussed above, we offer the following comments regarding your product labels:
1. Your Protein CoGo 20g Soy Protein Fruit Juice Drink Blend product label declares "20 grams of protein" and "20 g SOY PROTEIN"; however, these statements describe the amount of protein in the entire bottle, which is two serving sizes. Title 21 CFR 101.13(i)(3) states that the label or labeling of a product may contain a statement regarding the amount of a nutrient if the statement does not in any way implicitly characterize the level of the nutrient in the food and it is not false or misleading in any respect. The statements "20 grams of protein" and "20 g SOY PROTEIN" on your label are potentially misleading to consumers.
2. We reviewed your www.cogojuice.com website in February, 2013; we note that the nutrition facts information on the website for your Protein CoGo 20g Soy Protein Fruit Juice Drink Blend is not consistent with the information in the labeling that we collected at the inspection. You should ensure that the product labeling on both your product package and website accurately reflects the nutritional content for all of your products.
Please respond in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and ensure similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for your delay and the date by which each item will be corrected and documented.
Your written response should be sent to Jessica L. Kocian, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. If you have any questions about this letter, please contact Compliance Officer Jessica Kocian at 425-302-0444.
Charles M. Breen
cc: Vance Bybee, Administrator
Oregon Department of Agriculture
Food Safety Division
635 Capitol Street NE
Salem, Oregon 97301-0110