| Public Health Service Food and Drug Administration |
New England District |
Department of Health and Human Services
WARNING LETTER
NWE-13-11W
VIA UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
March 24, 2011
Mr. Robert Sanderson
Owner
Jonathan’s Sprouts Inc.
384 Vaughan Hill Road
Rochester, MA 02770
Dear Mr. Sanderson:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 384 Vaughan Hill Road, Rochester, MA, from September 27, 2010 to October 13, 2010. The inspection determined that your firm is a manufacturer and distributor of sprouts. During the inspection, our investigators collected sample labels for your Organic Mung Bean Sprouts, Organic Alfalfa Sprouts, Organic Clover Sprouts, and Organic Broccoli Sprouts. The FDA reviewed your website at http://www.jonathansorganic.com, in February 2011 and determined that this website constitutes labeling under section 201(m) of the Federal Food, Drug, and Cosmetic Act (the Act) because the website address appears on the label of your Organic Mung Bean Sprouts, Organic Alfalfa Sprouts, Organic Clover Sprouts, and Organic Broccoli Sprouts. Based on our review of your product labels and website, your Organic Mung Bean Sprouts, Organic Alfalfa Sprouts, Organic Clover Sprouts, and Organic Broccoli Sprouts products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] and are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. Regulations implementing the food labeling requirements of the Act can be found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and implementing regulations through links on FDA's Internet home page at http://www.fda.gov.
Unapproved New Drug
Your website address www.jonathansorganic.com appears on your Organic Mung Bean Sprouts, Organic Alfalfa Sprouts, Organic Clover Sprouts and Organic Broccoli Sprouts product labels. We have reviewed your website in February 2011 and have determined that your Organic Mung Bean Sprouts, Organic Alfalfa Sprouts, Organic Clover Sprouts and Organic Broccoli Sprouts products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. 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. Examples of some of the claims observed on your website from the webpage entitled “Sprouts, The Miracle Food! - Rich Vitamins, Minerals and Phytochemicals” and in a brochure entitled “Health Benefits of Sprouts” that can be viewed and downloaded from your website include, but are not limited to the following:
• “[S]prouts are full of phytochemicals . . . that are powerful allies in protecting us from the growth of cancer cells . . . in lowering cholesterol levels . . . .”
• “Mung Bean Sprouts Identified as Potent Anti-tumor Agent”
• “Studies on canavanine . . . in alfalfa, have demonstrated benefit for pancreatic, colon and leukemia cancers.”
• “Alfalfa Sprouts High in Cholesterol Lowering Agent”
• “Saponins [substance found in alfalfa sprouts] lower the bad cholesterol . . . . Animal studies prove their benefit in arteriosclerosis and cardiovascular disease.”
• “Phytoestrogens [substance in alfalfa, clover, and mung bean sprouts] . . . prevent . . . osteoporosis. They are also helpful in controlling . . . fibrocystic breast tumors.”
• “Research into the possible benefits of phytoestrogens has focused on . . . a) Cancer-breast and prostate in particular . . . c) Osteoporosis d) Heart disease (antioxidant activity) Other potential areas of benefit include diabetes . . . .”
• “The cruciferous sprouts: Broccoli, [lists others] . . . Cancer Fighters”
• “Broccoli . . . may fight cancer.”
• “Broccoli sprouts are rich in one class of cancer protecting agents.”
• “There is strong evidence that just two or three tablespoons of broccoli sprouts a day can help prevent cancer, gastric cancer, and other diseases.”
• “[S]ulforaphane [obtained from a substance in broccoli] prevents tumor growth and kills stomach bacteria that lead to ulcers and stomach cancer. In one study, they showed that feeding broccoli sprouts to rats prevented . . . heart disease, and stroke.”
These products are not generally recognized as safe and effective for the above referenced uses; therefore these 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 United States without prior approval from the 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. In addition, your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; hence adequate directions cannot be written so a layman can use them safely for their intended uses. Therefore, your products are also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for these drugs fail to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
Unauthorized Health Claims
Your Organic Alfalfa Sprouts, Organic Mung Bean Sprouts and Organic Clover Sprouts products are misbranded within the meaning of 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] because the labeling bears unauthorized health claims. Your website is referenced on each of the above product labels and was found to contain the following unauthorized health claims on the webpage entitled “Sprouts, The Miracle Food! - Rich in Vitamins, Minerals and Phytochemicals”:
• “[P]hytoestrogens [substance found in alfalfa, clover, and mung bean sprouts] . . . may have desirable effects, for example reduce the risk of breast cancer.”
• “Phytoestrogens actually reduce the risk of breast cancer.”
These health claims misbrand the products listed above because these health claims have not been authorized either by regulation [see section 403(r)(3)(A)-(B) of the Act [21 U.S.C. § 343(r)(3)(A)-(B)]] or under authority of the health claim notification provision of the Act [see section 403(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(C)]]. FDA has not authorized any health claims for phytoestrogens.
Unauthorized Nutrient Content Claims
Your Organic Alfalfa Sprouts, Organic Broccoli Sprouts, Organic Mung Bean Sprouts, and Organic Clover Sprouts 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. Under section 403(r)(2)(A)(i) 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 (and, by delegation, FDA) authorizing the use of such a claim. The use of a term, not defined by regulation, in food labeling to characterize the level of a nutrient of a type required to be in the labeling misbrands a product under section 403(r)(1)(A) of the Act. Specifically,
1. Your product labels and labeling bear antioxidant nutrient content claims but fail to comply with the requirements for using such a claim. Nutrient content claims using the term “antioxidant” must comply with, among other requirements, 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 under 21 CFR 101.54(b). 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 antioxidant claims found in your product labeling are nutrient content claims because they characterize the level of antioxidants in your product, but they do not comply with 21 CFR 101.54(g)(4) because they do not include the names of the nutrients that are the subject of the claim or link the nutrients with the claim by use of a symbol. This includes the following claims:
• On your website on the page entitled “Tasty, Nutritious Sprout Recipes: Index”: “All Sprouts are . . . HIGH IN ANTIOXIDANTS.”
• On your website on the page entitled “Sprouts, The Miracle Food! - Rich in Vitamins, Minerals and Phytochemicals”: “Sprouts also contain an abundance of highly active antioxidants . . . .”
2. In accordance with 21 CFR 101.54(b), the terms “high,” “rich in,” or “excellent source of” may be used to characterize the level of a nutrient on the label and in the labeling of foods provided that the food contains 20 percent or more of the RDI or the DRV per reference amount customarily consumed (RACC). Your Organic Mung Bean Sprouts, Organic Alfalfa Sprouts, Organic Broccoli Sprouts, and Organic Clover Sprouts products do not meet the requirements to make certain “high” claims that appear in your product labeling. Specifically:
The webpage entitled “Sprouts, The Miracle Food! - Rich in Vitamins, Minerals and Phytochemicals” found on your website bears the claim “Sprouts . . . Rich in Vitamins, Minerals . . .” However, as stated on your nutrition facts panels, your Organic Alfalfa Sprouts and Organic Clover Sprouts products both contain only 2 percent of the Reference Daily Intake (RDI) for vitamin A and calcium, 10 percent of the RDI for vitamin C, and 4 percent of the RDI for iron. Neither of these products contains vitamins or minerals at levels that are 20 percent or more of the RDI. In addition, as stated on your nutrition facts panels, your Organic Broccoli Sprouts contain 10 percent of the RDI for vitamin A, 60 percent of the RDI for vitamin C, 6 percent of the RDI for Calcium, and 4 percent of the RDI for Iron. Your Organic Mung Bean Sprouts contain 4 percent of the RDI for vitamin A, 20 percent of the RDI for vitamin C, 2 percent of the RDI for Calcium, and 4 percent of the RDI for Iron. Neither of these products contain minerals at 20 percent or more of the RDI.
Although your labels do state that your Organic Broccoli Sprouts and Organic Mung Bean Sprouts contain 20 percent or more of the RDI for vitamin C, the claim uses the plural “Vitamins,” implying that more than one vitamin should be present at levels of 20 percent or more of the RDI. Therefore your Organic Alfalfa Sprouts, Organic Clover Sprouts, Organic Broccoli Sprouts, and Organic Mung Bean Sprouts products do not meet the requirements to make “rich in” claims for vitamins and minerals.
• Your webpage entitled “Sprouts, The Miracle Food! - Rich in Vitamins, Minerals and Phytochemicals” bears the claim “Clover Sprouts High in Phytoestrogens[.]” This claim characterizes the level of nutrients of the type required to be in nutrition labeling (phytoestrogens) in your products by use of the defined term “high.” However, because there is no established RDI or DRV for phytoestrogens, this claim does not comply with the requirements for use of the term “high” in 21 CFR 101.54(b).
3. In accordance with 21 CFR 101.54(c), the term “good source” may be used to characterize the level of a nutrient on the label and in the labeling of foods provided that the food contains 10 to 19 percent of the RDI or the DRV per RACC. Your Organic Mung Bean Sprouts, Organic Alfalfa Sprouts, Organic Broccoli Sprouts, and Organic Clover Sprouts products do not meet the requirements to make the following “good source” claim that appears in your product labeling.
• Your webpage entitled “Tasty, Nutritious Sprout Recipes: Index” bears the nutrient content claim: “They [all sprouts] provide a good source of . . . calcium . . . as well as fiber, iron . . . .” However, as stated on your nutrition facts panels for your Organic Mung Bean Sprouts, Organic Alfalfa Sprouts, Organic Clover Sprouts, and Organic Broccoli Sprouts these products fail to contain at least 10 percent of the RDI for calcium and iron. All of these products, with the exception of your Organic Broccoli Sprouts product, also fail to meet the requirement to bear a good source of fiber claim because, as stated on your nutrition facts panels, they fail to contain at least 10 percent of the DRV for dietary fiber.
4. Your webpage entitled “Tasty, Nutritious Sprout Recipes: Index” bears the nutrient content claim “They [all sprouts] provide a good source of vitamins B . . . and K, phosphorus . . . potassium . . . and thiamin.” However, Your Organic Mung Bean Sprouts, Organic Alfalfa Sprouts, Organic Broccoli Sprouts, and Organic Clover Sprouts products product labels fail to provide information about the levels of vitamin B, vitamin K, phosphorus, potassium, and thiamin in those products as required under 21 CFR 101.9(c)(8)(ii), 101.9(c)(5), and 101.13(n). Therefore, these products are misbranded under section 403(q) and 403(r)(1)(A) of the Act. Further, because the nutrient levels are not declared, it is not clear whether the products have the required minimum 10 percent of the RDI or DRV per RACC of these nutrients as required under 21 CFR 101.54(c) for use of the defined term “good source.”
5. In accordance with 21 CFR 101.65(c)(2), the phrases “contains the same amount of [nutrient] as a [food]” and “as much [nutrient] as a [food]” may be used on the label or in the labeling of foods, provided that the amount of the nutrient in the reference food is enough to qualify that food as a “good source” of that nutrient, and the labeled food, on a per serving basis, is an equivalent, good source of that nutrient (e.g., “as much fiber as an apple,” “Contains the same amount of Vitamin C as an 8 oz. glass of orange juice.”). Your products fail to meet the requirements to make this type of implied nutrient content claim, which is contained in your product labeling. Specifically:
• Your webpage entitled “Sprouts, The Miracle Food! - Rich in Vitamins, Minerals and Phytochemicals” bears the implied nutrient content claim: “one-half cup of almost any sprouted seed provides as much Vitamin C as six glasses of orange juice.” According to your product labels one 85 g serving is equal to a cup of sprouts; therefore, one half of a labeled serving would equal a half cup. As stated on your nutrition facts panels, one half serving of your Organic Alfalfa Sprouts contains 5 percent of the RDI of Vitamin C, one half serving of your Organic Broccoli Sprouts contains 30 percent of the RDI of Vitamin C, one half serving of your Organic Clover Sprouts contains 5 percent of the RDI of Vitamin C, and one half serving of your Organic Mung Bean Sprouts contains 10 percent of the RDI of Vitamin C. However, based on the USDA National Nutrient Database,one 8 oz. serving of raw orange juice contains 124 mg of Vitamin C, which is over 200 percent of the RDI. Your Organic Alfalfa Sprouts, Organic Broccoli Sprouts, Organic Clover Sprouts, and Organic Mung Bean Sprouts do not contain as much Vitamin C as a single 8 oz. serving of orange juice and, by extension, do not contain as much Vitamin C as six 8 oz. glasses of orange juice; therefore, these products do not meet the requirements to make this claim.
• Your webpage entitled “Tasty, Nutritious Sprout Recipes: Index” bears the implied nutrient content claim: “By weight, most sprouts contain twice the protein of meat.” Your product labels declare an 85 gram serving size. As stated on your nutrition facts panels, 85 grams of your Organic Alfalfa Sprouts contains 3 grams of protein, 85 grams of your Organic Broccoli Sprouts contains 2 grams of protein, 85 grams of your Organic Clover Sprouts contains 3 grams of protein, and 85 grams of your Organic Mung Bean Sprouts contains 3 grams of protein. However, based on the USDA National Nutrient Database, an 85 gram serving of chicken tenders cooked in a conventional oven contains 13.41 grams of protein; an 85 gram serving of beef, bottom sirloin, tri-tip roast, separable lean and fat, trimmed to 0” fat, choice, cooked, roasted contains 21.81 grams of protein; and an 85 gram serving of pork, fresh, loin, sirloin (roasts), boneless, separable lean and fat, cooked, roasted contains 24.22 grams of protein. Your Organic Alfalfa Sprouts, Organic Broccoli Sprouts, Organic Clover Sprouts, and Organic Mung Bean Sprouts do not contain as much protein by weight as chicken, beef or pork, and, by extension, do not contain twice the protein by weight of chicken, beef or pork. Therefore, your products do not meet the requirements to make this claim.
6. In accordance with 21 CFR 101.61(b)(1)(i), the term “sodium free” may be used on the label or in the labeling of foods provided that the food contains less than 5 mg of sodium per RACC and per labeled serving. The webpage entitled “Tasty, Nutritious Sprout Recipes: Index” bears the claim “Sprouts are sodium free.” Your Organic Broccoli Sprouts contain 25 mg of sodium per 85 g labeled serving as declared on your nutrition facts panel; therefore, it does not meet the requirements to make a “sodium free” claim.
7. Your Organic Clover Sprouts product label bears the claim “Phytoestrogen Source[.]” Your webpage entitled “Sprouts, The Miracle Food! - Rich in Vitamins, Minerals and Phytochemicals” bears the claim “Alfalfa sprouts are one of our finest food sources of . . . saponin.” These claims are nutrient content claims subject to section 403(r)(1)(A) of the Act because they characterize the level of nutrients of a type required to be in nutrition labeling (phytoestrogen and saponin) in your products by use of the term “source.” 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. However, FDA has not defined the characterization “source” by regulation. Therefore, this characterization may not be used in nutrient content claims.
We acknowledge your firm's efforts in addressing the issues raised in the FDA-483 Inspectional Observations that was issued to you on October 13, 2010 and the specific corrections your letter indicates that you have made. Your corrective actions will be further evaluated during our next inspection of your facility and your response will be filed as a part of the inspectional record for this facility. The above violations are not meant to be an all inclusive list of deficiencies on your labels. It is your responsibility to assure that all of your sprout products are labeled and processed in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to make prompt corrections could result in regulatory action without further notice. Possible actions include seizure and/or injunction.
We also have the following comments about your product labels:
Your Organic Mung Bean Sprouts, Organic Alfalfa Sprouts, Organic Clover Sprouts, and Organic Broccoli Sprouts are single ingredient foods and therefore are not required to bear an ingredients declaration under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. You have elected to provide ingredients statements on these products. Your ingredients statements on each of these products declare the corresponding type of seed (i.e. “Contents: Organic Alfalfa Seeds”). However, as required by section 403(i)(2) of the Act, your ingredient declaration must use the food’s common or usual name, which is the name of the specific kind of sprout (i.e., “Contents: Alfalfa Sprouts”).
Your Organic Alfalfa Sprouts, Organic Clover Sprouts, and Organic Broccoli Sprouts product labels contain the statements “Certified Organic by QAI,” and “Product of USA” on the information panel between the name and place of business and ingredients statement. However, 21 CFR 101.2(e) requires that all required information appearing on the information panel shall appear in one place without intervening material.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Attention: Lori A. Holmquist, Compliance Officer, 330 Civic Center Drive, Suite 1, Box 4, Augusta, Maine 04330. If you have questions regarding any issues in this letter, please contact Ms. Holmquist at 207.622.8268 x13.
Sincerely,
/S/
Mutahar S. Shamsi
District Director
New England District
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