Inspections, Compliance, Enforcement, and Criminal Investigations
Hato Potrero Farm, Inc 03-Apr-08
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
April 3, 2008
Hato Potrero Farm, Inc.
Gustavo A. Perez, President
611 East Obispo Avenue
Clewiston, FL 33440-4722
Dear Mr. Perez:
The U.S. Food and Drug Administration (FDA) inspected your facility located at 611 East Obispo Avenue, Clewiston, Florida on November 7, 2007. During the inspection, our investigator collected labels of your firm's Yo Gusto™ Smoothie Drinkable Yogurt, Kumis, and Hato Potrero cheese products. Our review of your product labels, in addition to the promotional claims viewed on your website at http://yogusto.com in February 2008, found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and FDA's regulations through links on FDA's Internet page at www.fda.gov.
Unapproved New Drugs/Misbranded Drugs
We have determined that the subpages of your website http://yogusto.com, a link to which appears on your products' labels, are labeling within the meaning of section 201(m) of the Act for these products. Based on the claims made on that site, we have determined that your Yo Gusto™ Smoothie Drinkable Yogurt products are promoted for conditions that cause them to be drugs.
Examples of some of the claims observed on your website are as follows:
Yo Gusto™ Smoothie Strawberry Drinkable Yogurt product:
• "Medicinally, strawberries have been shown to kill certain viruses (polio and herpes) in vitro, and may block the formation of nitrosamines, which can cause cancer..."
• "Strawberries contain relatively high quantities of ellagic acid ... hemorrhage [is] inhibited by ellagic acid."
Yo Gusto™ Smoothie Peach Drinkable Yogurt product:
• "Peaches contain 'prunasin' also known as vitamin B15 to be considered a therapeutic particularly for cancer (tumor) treatment."
Yo Gusto™ Smoothie Guava Drinkable Yogurt product:
• "Due to their astringent properties, mature guava fruits, are used in local medicines to treat gastroenteritis . . . and dysentery. Guavas significantly reduce serum total cholesterol, triglycerides, and blood pressure with the opposite effect (an explicit increase) in high-density lipoprotein (HDL) or good cholesterol"
Yo Gusto™ Smoothie Pinacolada Drinkable Yogurt product:
• "In traditional medicine around the world coconut is used to treat a wide variety of health problems including the following: abscesses, asthma ... bronchitis ... colds ..."
Yo Gusto™ Smoothie Pineapple Drinkable Yogurt product:
• "[P]ineapple has benefits for some intestinal disorders ...."
Further, your website promotes the yogurt products with the following claims under the header "Health Benefits":
• "Dr. Meydani suggests great promise for future studies on yogurt's potential as a protective anti-infection agent."
• "'Increased yogurt consumption might help increase one's resistance to immune related disease such as cancer and infection, particularly gastrointestinal infection,' says Dr. Meydani. 'The increase in resistance is in part because of the live and active cultures found in yogurt.'"
• "Yogurt's Top Ten ..."
o "Combats Yeast Infections"
The presence of the above referenced claims indicates that the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Such claims are evidence that the products are intended for use as drugs within the meaning of Section 201(g)(I)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. The products are new drugs under section 201(p) of the Act because there is no evidence that these products are generally recognized as safe and effective for their intended uses. Therefore, they may not be legally marketed in the United States without approved New Drug Applications (Section 505 of the Act). Your yogurt products are also misbranded drugs under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling fails to bear adequate directions for use.
Your Yo Gusto™ Smoothie Drinkable Yogurt products are misbranded under section 403(r)(1)(B) of the Act [21 U.S.C. 343(r)(1)(B)] because they bear unauthorized health claims. In particular, you make the following claims for your products on your website:
Yo Gusto™ Smoothie Strawberry Drinkable Yogurt: "Strawberries contain relatively high quantities of ellagic acid ... ne study showed that cancer among the elderly was reduced 3-fold by eating strawberries."
This statement is an unauthorized health claim because, in part, it does not meet the requirements listed in 21 CFR 101.78(c) for a health claim associating diets low in fat and high in fruits and vegetables that are good sources of vitamin A, vitamin C, or dietary fiber with a reduced risk of some cancers. Moreover, FDA has not authorized a health claim associating ellagic acid with reduced risk of cancer.
Yo Gusto™ Guava Drinkable Yogurt: "[H]igh concentrations of pectin in guava fruit may play a significant role in the reduction of cholesterol and thereby decrease the risk of cardiovascular disease."
This statement also does not qualify for the health claim associating diets low in fat and high in fruits and vegetables that are good sources of vitamin A, vitamin C, or dietary fiber with a reduced risk of some cancers because; in part, it does not meet the requirements of 21 CFR 101.78(c). No health claims about pectin and reduced risk of cardiovascular disease have 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)]).
Under the header "Health Benefits" and subheading "Yogurt's Top Ten ...":
• "May Help Reduce Osteoporosis Risk"
• "Colon Protection ... increasing one's dietary intake of lowfat, calcium-rich dairy products such as yogurt may reduce the risk of colon cancer."
Although FDA has authorized a health claim associating calcium with a reduced risk of osteoporosis [21 CFR 101.72], the statement regarding yogurt and reduced risk of osteoporosis is an unauthorized health claim because, in part, it does not meet the requirements of 21 CFR 101.72(c). The claim associating lowfat, calcium-rich dairy products with a reduced risk of cancer is an unauthorized health claim because FDA has not authorized a claim about this substance-disease relationship.
Further, your products are also misbranded under section 403(q) of the Act [21 U.S.C. 343(q)] because the nutrition information on their labels does not comply with the requirements in FDA's regulations [21 CFR 101.9]. For example:
• Your Yo Gusto™ Smoothie Peach Drinkable Yogurt (16 fl. oz.), Hato Potrero Queso Fresco Michoacan Fresh Mexican Cheese (1 lb.), and Hato Potrero Queso Panela Soft Cheese (5 lbs.) product labels fail to declare trans fat, as required by 21 CFR 101.9(c)(2)(ii). For additional information on trans fat labeling requirements, go to http://www.cfsan.fda.gov/~dms/lab-cat.html#transfat.
• Your Yo Gusto™ Smoothie Drinkable Yogurt (Natural, 12 and 64 fl. oz.; Natural Unsweetened, 64 fl. oz; Strawberry, 16 and 64 fl. oz; Bananaberry, 64 fl. oz.; Pineapple, 12, 16, and 64 fl. oz.; Pinacolada, 12 and 64 fl. oz.; Mango, 12, 16, and 64 fl. oz.; and Peach, 12, 16, and 64 fl. oz.), Yo Gusto™ Smoothie Kumis Cultured Milk (12, 16, and 64 fl. oz.), Hato Potrero Queso Blanco White Soft Cheese (1 lb.), Hato Potrero Queso Fresco Michoacan Fresh Mexican Cheese (1 lb.), and Hato Potrero Queso Panela Soft Cheese (5 lbs.) product labels fail to express serving sizes in both common household measures and equivalent metric quantities, as required by 21 CFR 101.9(b)(7). The serving size for your 16 and 64 fl. oz. drinkable yogurts should state, for example, "8 fl oz (240 ml)," and the cheese products serving size should state, for example, "1 oz (28 g/about 1/2-inch x 1-inch slice [or appropriate visual unit of measure])" (21 CFR 101.9(b)(5)(iii)). For additional information on Nutrition Facts labeling requirements, go to http://www.cfsan.fda.gov/~dms/lab-ind.html.
• Your Yo Gusto™ Smoothie Drinkable Yogurt (Natural, 12 and 64 fl. oz.; Natural Unsweetened, 64 fl. oz; Strawberry, 16 and 64 fl. oz; Bananaberry, 64 fl. oz.; Pineapple, 12, 16, and 64 fl. oz.; Pinacolada, 12 and 64 fl. oz.; Mango, 12, 16, and 64 fl. oz.; and Peach, 12 and 64 fl. oz.) and Yo Gustor™ Smoothie Kumis Cultured Milk (12, 16, and 64 fl. oz.) product labels declare saturated fat, trans fat, polyunsaturated fat, monounsaturated fat, fiber, and sugar contents, but the names of these nutrients are not indented according to the requirements of 21 CFR 101.9(c). The label for your Peach Drinkable Yogurt (16 fl. oz.) declares saturated fat, fiber, and sugar, and also does not indent the names of these nutrients. Further, the nutrients and their corresponding percent Daily Values must be separated by a hairline from the nutrients and Daily Values above and below them, as required by 21 CFR 101.9(d)(1)(v).
• Your Yo Gusto™ Smoothie Kumis Cultured Milk (12 fl. oz.) and Yo Gusto™ Smoothie Drinkable Yogurt (Pinacolada, 12 fl. oz.; Natural, 12 fl. oz.; Mango, 12 fl. oz.; and Peach, 12 fl. oz.) declare 1.5 servings per container. The net quantity of contents for these products is 355 mL. The Reference Amount Customarily Consumed for beverages is 240 mL. Because these products are packaged and sold individually and contain less than 200% of the reference amount, they are considered single-serving containers; therefore, they must be labeled as one serving, as required by 21 CFR 101.9(b)(6).
This letter is not an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and FDA regulations.
The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.
In addition to the violations described above, we have the following comments concerning the labeling of your products:
• "Kumis" is prominently displayed on your Yo Gusto™ Smoothie Kumis Cultured Milk product labels. Our research indicates that kumis is traditionally fermented from mare's milk (i.e., from a horse) and not from cow's milk.. The use of "Kumis" on the label for this product, which is identified as cultured cow's milk, could be misleading: In addition, "cultured milk" is the name of a standardized food that could not be made with mare's milk.
• Your Yo Gusto™ Smoothie Drinkable Yogurt and Kumis Cultured Milk products are fabricated from two or more ingredients and fail to declare the common or usual name of each ingredient, as required by 21 CFR 101.4. Specifically, "living cultures" is not a common or usual name. You may declare bacterial cultures by declaring the word "cultured," followed by the name of the substrate (21 CFR 101.4(b)(5)). Additionally, "evaporated sugar cane juice" is not a common or usual name. It is your responsibility to determine what this ingredient is (i.e., whether it is sucrose or another sweetener) and declare its common or usual name (see 21 CFR 101.4(b)(20)).
• With respect to your Yo Gusto™ Kumis Cultured Milk products, the term "Cultured Milk" is the name of a standardized food under 21 CFR 131.112. According to 21 CFR 131.112(f)(1)(ii), the term "sweetened" must accompany the name of a food to which a nutritive carbohydrate sweetener is added without the addition of characterizing flavoring. Therefore, if the ingredient "evaporated sugarcane juice" is a nutritive carbohydrate sweetener under 21 CFR 131.112(d)(2), the term "sweetened" must be used. The term "sweetened" does not accompany the name of the food in the Kumis Cultured. Milk product labels.
Please notify this office in writing within fifteen (15) working days of your receipt of this letter of the specific steps you have taken to correct. the violations noted above and to assure that similar violations do not occur. You should include in your response documentation to support your corrections, such as revised finished product package labels and website revisions. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your reply to the U.S. Food and Drug Administration, Attention: Matthew B. Thomaston, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issue in this letter, please contact Mr. Thomaston at (407) 475-4728.
Emma R. Singleton
Director, Florida District