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FDA Enjoins Beverage Maker’s Operations until it Complies with the FDCA

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On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it has entered into a consent decree of permanent injunction with Jonlly Fruits, Inc. (“Company”) and its President, Bartolo Pérez Román. Jonlly Fruits is a frozen fruit, juice, and vegetable manufacturing company located in Puerto Rico.  Under the consent decree, signed by Judge Gustavo A. Gelpi of the U.S. District Court for the District of Puerto Rico, the Company agrees to cease all operations until it complies with the Federal Food, Drug, and Cosmetic Act (“FDCA”). This will include complying with Current Good Manufacturing Practice (“cGMP”) and Hazard…
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FDA Investigates Illnesses Linked to Energy Drinks and Supplements

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On November 16, 2012, the U.S. Food and Drug Administration (“FDA”) issued a statement concerning the Agency’s ongoing investigation of reported illnesses and deaths linked to energy drinks and energy shot supplements. Found here, the Statement details the FDA’s efforts in this area, including its evaluation of adverse event reports. According to the FDA, it is currently in the process of determining whether there is an actual cause-and-effect relationship between the consumption of energy drinks and energy supplements and these medical problems. Under the Federal Food, Drug and Cosmetic Act (“FFDCA”), manufacturers, packers and distributors of all dietary supplement products…
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FDA Warns Makers of RockStar Coffee & Energy Products

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On May 23, 2012, the U.S. Food and Drug Administration (“FDA”) issued a Warning Letter to the manufacturers of the widely popular RockStar energy products, Rockstar , Inc. (“the Company”). Found here, the Letter contains various allegations that the Company’s products are adulterated under the Federal Food, Drug and Cosmetic Act (“FFDCA”) and FDA regulations. In particular, the Company’s RockStar Roasted Coffee & Energy products, including Premium Blended Mocha Cream & Coffee, Premium Blended Latte Cream & Coffee, and Light Vanilla flavors, are allegedly adulterated under the FFDCA because of the ingredients used and the way they are marketed. Pursuant…
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FTC May Have Won Battle with POM Wonderful but Industry Appears to Have Won the War

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On May 21, 2012, the Federal Trade Commission (“FTC”) announced that it has prevailed in its claim against POM Wonderful LLC (“The Company”) pursuant to a recent ruling by Chief Administrative Law Judge (“ALJ”), D. Michael Chappell. In an Order dated May 17, 2012, Judge Chappell directed the juice giant to refrain from making statements that POM Wonderful 100% Pomegranate Juice and POMx supplements can prevent or treat heart disease, erectile dysfunction and prostate cancer unless the Company has “competent and reliable scientific evidence” to substantiate these claims. Although the FTC is largely heralding the ALJ’s order as a victory,…
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FDA Warns of Recall Due to Undeclared Milk Derivatives in Several Beverage Products

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On May 10, 2012, the U.S. Food and Drug Administration (“FDA”) posted a press release on its website notifying consumers of a recent recall of various fruit beverages. Jonlly Fruits Inc., the manufacturer of the beverages, opted to initiate the voluntary recall of the affected products after labeling deficiencies were uncovered during the FDA’s inspection of its facilities. According to the Company’s press release, several of its products may contain the milk derivative sodium caseinate. Under the Food Allergen Labeling and Consumer Protection Act and its corresponding FDA regulations, manufacturers and/or labelers of finished food products are required to declare…
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FDA Explains its Regulation of Bottled Water

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Recently, the U.S. Food and Drug Administration (“FDA”) published “Food Facts”, a document providing the public with information concerning the Agency’s regulation of bottled water. Found here, the document details how the Agency works in conjunction with the Environmental Protection Agency (“EPA”) to ensure that drinking water is safe. While the EPA is primarily responsible for the nation’s tap water, the FDA is the regulatory body responsible for overseeing bottled water. The regulation of bottled water may be broken into two main areas: CGMPs and labeling. Current Good Manufacturing Practices (“CGMPs”) are the particular guidelines that producers of most FDA-regulated…
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