- Arden's Garden
- Issuing Office:
- Atlanta District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Atlanta District Office |
60 Eighth Street N.E.
Atlanta, GA 30309
August 20, 2015
Mrs. Leslie H. Zinn, President/Owner
3113 Main Street
East Point, GA 30344-4802
Dear Mrs. Zinn:
The U.S. Food and Drug Administration (FDA) has reviewed your product labels, and we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s website at www.fda.gov
Based on our review of the labels for your Veg-Aholic, Pure Lemon, Beet it Better, and Pump up the Protein products, we have determined that your products are being promoted for conditions that cause them to be drugs within the meaning of Section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. The therapeutic claims made on your products’ labels establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
The therapeutic claims observed on your products’ labels include, but may not be limited to, the following:
- “[T]his juice can help lower cholesterol…fight cancer…”
- “[L]emon juice can be effective in preventing cancer….”
BEET IT BETTER
- “[T]his juice can help reduce heart disease & cancer…”
PUMP UP THE PROTEIN
- “Pump up the Protein is loaded with soy protein which . . . promotes wound healing…”
- “[S]oy protein’s ability to reduce coronary heart disease. It has also shown the potential to prevent certain cancers and osteoporosis.”
Your Veg-aholic, Pure Lemon, Beet it Better, and Pump up the Protein 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 introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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 Veg-aholic, Pure Lemon, Beet it Better, and Pump up the Protein products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. 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)].
Unapproved Food Additive
1. Your REAL ENERGY product is adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(2)(C)(i)] because it bears or contains an unsafe food additive. Adulterated food cannot be legally marketed in the United States. Specifically, your REAL ENERGY product contains ginkgo biloba extract. This substance is an unsafe food additive within the meaning of section 409 of the Act [21 U.S.C. 348], in that the substance, its use, or intended use is not in conformity with a regulation issued under this section prescribing the conditions under which such additive may be safely used. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations (21 CFR), Part 170.
Any substance added to a conventional food, such as your REAL ENERGY product, 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 are no food additive regulations that authorize the use of the aforementioned substance in your REAL ENERGY product. We are not aware of any information to indicate that this substance is the subject of a prior sanction [see 21 CFR Part 181]. As explained below, we are not aware of any basis to conclude that this substance 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).1
We know of no basis for general recognition of safety for the ginkgo biloba extract used in your REAL ENERGY product, based either on scientific procedures or common use in food prior to January 1, 1958. In assessing the GRAS status of the aforementioned substance for use in conventional foods such as your REAL ENERGY product, we considered the criteria described above. FDA is not aware of data to establish the safety of the aforementioned substance for use as an ingredient in conventional foods. Therefore, the use of this substance in your REAL ENERGY 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 biloba extract for use as an ingredient in conventional foods. Therefore, this substance added to a conventional food is a food additive under section 201(s) of the Act and is subject to the provisions of section 409 of the Act [21 U.S.C. 348]. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. The aforementioned substance added to your REAL ENERGY product is not approved for use in any food. Therefore, this product is adulterated within the meaning of section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(2)(C)(i)].
- Your Complete Recovery product is misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that it contains false or misleading information. Specifically, the principal display panel uses the term "Fresh" to describe the product. However, records indicate that the product is made with (b)(4) and (b)(4). Under 21 CFR 101.95, the term "fresh," when used on the label or in labeling of a food in a manner that suggests or implies that the food is unprocessed, means that the food is in its raw state and has not been frozen or subjected to any form of thermal processing or any other form of preservation. Describing this product as a "fresh" fruit smoothie is false because it is made from (b)(4).
- Your Veg-Aholic, 2 Day Detox, and Complete Recovery 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, but the products do not meet the requirements to make such claims.
Under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)], 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 nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. Specifically,
- The label bears the nutrient content claims "Full of folic acid, flavonoids, carotenoids, and vitamins . . . K... this juice is loaded with antioxidants ..."
o FDA has not defined the terms "full of” or "loaded with" by regulation. Under section 403(r)(2)(A) of the Act, nutrient content claims may be made only if the characterization of the level made in the claim uses terms which are defined by regulation. Because this claim is not authorized as a nutrient content claim by regulation or by the Act, the claim misbrands the product.
o Even if the term "full of” could be considered a synonym for "high" or "good source", which are nutrient content claims authorized by regulation, the claim “full of . . . flavonoids, carotenoids” does not comply with the requirements for use of those terms in 21 CFR 101.54(b) ("high" claims) or 21 CFR 101.54(c) ("good source" claims) because there is no established Reference Daily Intake (RDI) or Daily Reference Value (DRV) for flavonoids or carotenoids in general. Therefore, the use of the term “high” or “good source” to characterize the level of flavonoids or carotenoids in your product misbrands your product under section 403(r)(1)(A) of the Act. In addition, regarding the “full of folic acid . . . and vitamins . . . K . . .” claim, because the label for your Veg-Aholic product does not declare folic acid or vitamin K, as required by 21 CFR 101.9(c)(8)(ii), it is not clear whether the product complies with the requirements for use of the term “high” or “good source.”
We note that there are alternative ways to convey the amount of nutrients in your products to consumers. For example, the amount of a nutrient in a food may be stated on the product label or labeling in accordance with the requirements in 21 CFR 101.13(i). If you want to seek authorization to use your current claims, you may submit a petition requesting FDA to authorize new nutrient content claims (see 21 CFR 101.69). FDA’s review and authorization of a nutrient content claim prior to use in labeling ensures that the claim will provide consistent, meaningful information to consumers about the nutritional content of a product.
Additionally, your website at http://www.ardensgarden.com/our-juices/ contains a “more” nutrient content claim. Your webpage states "[Arden's Garden juices] contains more than double the nutrients…of a centrifugal juice" followed by a chart comparing the amounts of calcium, magnesium, phosphorus, iron and potassium found in pressed vs. centrifugal juice.
"More" nutrient content claims are defined in 21 CFR 101.54(e). "More" nutrient content claims may be used on the label or in the labeling of foods to describe the level of protein, vitamins, minerals, dietary fiber or potassium, provided that (1) the food contains at least 10 percent more of the RDI or DRV for the nutrient per reference amount customarily consumed (RACC) than an appropriate reference food; (2) where the claim is based on nutrients that are added to the food, that the fortification is in accordance with the policy on fortification of foods in 21 CFR 104.20; and (3) the claim bears the required information for relative claims as described in 21 CFR 101.13(j)(2) and 101.54(e)(1)(iii).
However, the claim on your webpage, “[Arden’s Garden juices] contain more than double the nutrients…of a centrifugal juice,” does not provide quantitative information comparing the level of the nutrient in the product per labeled serving with that of the reference food that it replaces [21 CFR 101.54(e)(l)(iii)(B)]. The chart provides quantitative comparisons of the amounts of nutrients in 40.5 oz. of centrifugal juice to 57 oz. of pressed juice. The claim also does not provide the percentage (or fraction) that the nutrients are greater relative to the RDI or DRV [21 CFR 101.54(e)( l )(iii)(A)].
Furthermore, if the values in the chart are converted to percent daily values per 8 oz. (which is the RACC), there are insufficient levels of magnesium, phosphorus and potassium to qualify for a "more" nutrient content claim. Specifically, an 8 oz. serving of pressed juice would only contain about 0.8%, 1%, and 0.13% of the RDI or DRV for magnesium, phosphorus, and potassium respectively, and therefore, would not meet the requirement that the food contain at least 10% more of the RDI or DRV per reference amount customarily consumed than an appropriate reference food, as required by 21 CFR 101.54(e)(1)(i).
- Your Arden’s Garden FRESH Nutri-Boost Fruit Smoothie REAL ENERGY products (hereon referred to as REAL ENERGY) is misbranded within the meaning of section 403(u) of the Act [21 U.S.C. § 343(u)] in that it purports to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, added by the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171), provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Your product contains an ingredient identified as Siberian Ginseng (Eleutherococcus senticosus). That ingredient may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax.
- Your 2 DAY DETOX product is misbranded under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products label fails to declare the total percentage of fruit or vegetable juice in accordance with 21 CFR 101.30. Beverages that purport to contain juice (fruit or vegetable juice) must declare the %juice. Included are beverages that purport to contain juice by way of label statements, by pictures of fruits or vegetables on the label, or by taste and appearance causing the consumer to expect juice in the beverage. The %juice declaration must be on the information panel (for packages with information panels). If the package does not have an information panel, the percent juice must be placed on the PDP in a type size not less than that required for the net contents declaration and placed near the name of the food, in accordance with 21 CFR 101.30(e) and (g). The placement and type size of the total juice percentage declaration on the Complete Recovery and Veg-Aholic products does not comply with 21 CFR 101.30(e).
Your Veg-Aholic, Complete Recovery, and 2 Day Detox products are also 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 and the labels fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. For example:
- The label declares apples as an ingredient, when in fact, (b)(4) is used.
- The label declares the ingredients “fresh apples, oranges, strawberries, bananas” as ingredients, when in fact; (b)(4) are used.
2 Day Detox
- The label declares "fresh grapefruit, fresh oranges, fresh lemons" as ingredients, when in fact, (b)(4) is used. Occasionally, (b)(4).
5. Your 2 Day Detox product is misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because there is no statement of identity on the Principal Display Panel, as required under 21 CFR 101.3. “2 Day Detox” is not an appropriate descriptive term for this food.
6. Your Veg-Aholic, 2 Day Detox, and Complete Recovery products are misbranded within the meaning of Section 403(q) of the Act [21 U.S. C.343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example:
- The declaration of vitamins and minerals as the percent of the RDI shall include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are added as a nutrient supplement, or when a claim is made. As stated above, claims are made about folic acid and vitamin K; however, the percent daily values for these nutrients are not declared on the label as required by 21 CFR 101.9(c)(8).
- The amount of fat is not declared in accordance with 21 CFR 101.9(c)(2). There is no provision that allows for total fat content to be declared in a “not a significant source of ___” statement.
- The statement “Product contains no…” is not provided for by 21 CFR 101.9. We note that the “not a significant source of ___” footnote is provided for by 21 CFR 101.9(c). When used, it must appear below the table of nutrient values, as opposed to the location in which the “product contains no ....” statement appears. In addition, the nutrients are not listed in the proper order. The nutrients in the “not a significant source of” statement are not declared in the order specified in 21 CFR 101.9(c).
- The label bears the claim “high in vitamins ... E.” However, the nutrition label does not declare the percent daily value of vitamin E as required under 21 CFR 101.9(c)(8)(ii).
- There is no declaration of trans fat as required by 21 CFR 101.9(c)(2)(ii).
- The total fat is declared as 0.25 g. However, under 21 CFR 101.9(c)(2), if the serving contains less than 0.5 g, the fat content shall be expressed as zero.
This letter is not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your products are in compliance with the Act and FDA’s implementing regulations. You should take prompt action to correct all of the violations cited in this letter and prevent their recurrence. Failure to promptly correct these violations may result in FDA taking enforcement action, such as seizure or injunction, without further notice.
We also offer the following comments:
1. Your 2 Day Detox bears the claim "more than 100% of the recommended daily allowance of essential vitamins." This claim may be misleading to the extent that it indicates that all vitamins are present in more than 100% of the recommended daily allowance. While the Nutrition Facts label for your product indicates that 122% of the RDI for vitamin C is present in your product, we note that the Nutrition Facts label for your product also indicates that 16% of the RDI for vitamin A is present in the product, and does not declare the amount of other vitamins.
2. We note that your products must also comply with other requirements related to formatting and rounding of nutrient values and percent daily values in 21 CFR 101.9.
3. We note that to the extent you are a juice processor, you must comply with the applicable juice Hazard Analysis and Critical Control Point (HACCP) requirements in 21 CFR Part 120.
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above-noted violations and prevent similar ones. Please provide any documentation that will effectively assist us in evaluating your corrective actions. If you are unable to complete the corrective actions within fifteen (15) working days, identify 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 questions, please contact Mrs. Morton at 404-253-1285 or write her at the noted address.
1 Guidance for Industry and Other Stakeholders: Toxicological Principles for the Safety Assessment of Food Ingredients, Redbook 2000, available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/Redbook/default.htm.