Inspections, Compliance, Enforcement, and Criminal Investigations
Universal Taste Inc. 8/7/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|555 Winderley Pl., Ste. 200
Maitland, Fl 32751
RETURN RECEIPT REQUESTED
August 7, 2009
Guilherme C. Moreira, President
Universal Taste Inc.
1921 N.E. 153rd St.
North Miami Beach, Florida 33162
Dear Mr. Moreira:
We inspected your juice processing facility, located at 1921 N.E. 153rd St., North Miami Beach, FL 33162, on February 12-13, 20-23, 2009, and March 2-3, 2009. We found that you have serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120).
Failure of a juice product importer to comply with the requirements of 21 CFR 120.14 renders its juice products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Accordingly, your frozen pasteurized acai concentrate with 14% pulp is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. In addition, our FDA investigators collected the labeling for your Acai+ Power Scoops Plus dietary supplement products. Our review of the labeling for these products, including your website at http://www.universaltaste.com. revealed serious violations of the Act. You may find the Act, the juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
Because the country from which you are importing your juice does not have an active memorandum of understanding (MOU) or similar agreement with FDA that covers the juice you import [21 CFR 120.14(a)(1)], your company must comply with the requirements of 21 CFR 120.14(a)(2). However, your firm failed to have and implement written procedures for ensuring that the juice you import into the United States was processed in accordance with the requirements of 21 CFR Part 120, as required by 21 CFR 120.14(a)(2). These written procedures must include, at a minimum, product specifications that are designed to ensure that the juice is not adulterated under section 402 of the Act because it may be injurious to health or because it may have been processed under insanitary conditions [21 CFR 120.14(a)(2)(i)], and affirmative steps to ensure that the products being offered for entry were processed under controls that meet the requirements of 21 CFR Part 120 [21 CFR 120.14(a)(2)(ii)]. Specifically:
• You failed to have and implement written procedures that provide affirmative steps for the frozen acai concentrate with pulp product from your foreign processor, (b)(4) You imported (b)(4) steel drums each with a net weight of (b)(4) lbs. and totaling (b)(4) lbs. on 9/30/08 and (b)(4) steel drums each with a net weight of (b)(4) lbs. and totaling (b)(4) lbs. on 10/13/08 of frozen acai pulp from this contract manufacturer into the United States but, during the inspection, were unable to provide written procedures listing affirmative steps for this product.
• You failed to have and implement written procedures that provide affirmative steps for the frozen acai concentrate with pulp product from your foreign processor, (b)(4). You imported (b)(4) steel drums each with a net weight of (b)(4) lbs. and totaling (b)(4) lbs. on 2/6/09 of frozen acai pulp from this contract manufacturer into the United States but, during the inspection, were unable to provide written procedures listing affirmative steps for this product.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported juice under section 801 of the Act (21 U.S.C. 381(a)), including placing it on detention without physical examination, seizing your products, and/or enjoining your firm from operating.
Under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)), articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs. The therapeutic claims on your labeling, including your website, establish that these products are intended to be used as drugs. The marketing of these products with these claims violates the Act.
Specific examples of claims in your product labeling that promote your products as drugs are as follows:
On your product labels:
Acai+ Power Scoops Plus Organic Acai + Camu-Camu
• "It is a natural cholesterol controller which helps to reduce bad cholesterol. ... "
• "Best natural anti-depressant"
• "Fights herpes virus"
• "Fights cataracts and glaucoma"
• "Combats infertility"
Acai Power Scoops Plus Acai + Carou-Carou + Maca
• "Scoops Plus Maca is a combination of Acai ... and the benefits of Maca.... Maca powder has been used to help relief [sic] the symptoms of ... chronic
fatigue, depression ...."
On your website:
Acai Power Scoops
• "It helps to fight the buildup of LDL, or bad cholesterol, in the body ...."
• "It is number 1 natural source to combat Colds, Cataracts and Glaucoma, Asthma, Edema, Atherosclerosis, Hepatitis, Infertility, Parkinson's Disease, Gingivitis,
Migraine, Osteoarthritis, Painkiller, and Depression"
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, they are also 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 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 misbranded under section 502(f)(1) of the Act in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. 352(f)(1)].
Even if your Acai+ Power Scoops Plus Organic Acai + Camu-Camu and Acai Power Scoops Plus Acai + Camu-Camu + Maca products did not contain disease claims in their labeling that cause them to be drugs, they would still be misbranded as dietary supplements. These products are misbranded under section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the nutrition information on their product labels does not comply with 21 CFR 101.36(b)(1) because your product is labeled as a dietary supplement and does not declare the required information in a panel that includes the heading "Supplement Facts."
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 such as HACCP and verification records, 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.
In addition to the above violations, we also have the following comment regarding your labeling. The labels of your Acai+ Power Scoops Plus Organic Acai + Camu-Camu and Acai Power Scoops Plus Acai + Camu-Camu + Maca products claim that the products are "rich in PROTEINS, VITAMIN E, MINERALS, AND ESSENTIAL FATTY ACIDS." The nutrient content claim "rich in" may be made for a nutrient only if the food contains 20% or more of the Recommended Daily Intake (RDI) or Daily Reference Value (DRV) of the nutrient per reference amount customarily consumed (RACC) (21 CFR 101.54(b)). You should ensure that your use of this nutrient content claim complies with the requirements of 21 CFR 101.54(b). Additionally, this claim indicates that according to their labels, these products do not contain vitamin E. Finally, authorized nutrient content claims are limited to substances that have an RDI or DRV, and there is no RDI or DRV for "essential fatty acids."
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act and the juice HACCP regulation (21 CFR Part 120). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Mr. Alejo at (407) 475-4731.
Emma R. Singleton
Director, Florida District