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U.S. Marshals Seize Products from California Firm upon FDA ’s Repeated Finding of Violations

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On May 22, 2012, the U.S. Food and Drug Administration (“FDA”) announced that U.S. Marshals, acting at the requests of the Agency, had seized certain products deemed to be unapproved new drugs. HybriSil (methylprednisolone acetate 1% in silicone gel), the drug at issue was being marketed without FDA approval and therefore in violation of the Federal Food, Drug and Cosmetic Act (“FFDCA”). In particular, the seizure came as a result of two inspections conducted by the Agency, where the firm was found to be selling the product in violation of a number of FDCA provisions. Crescendo Therapeutics, LLC, the firm…
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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 Notifies Consumers of Supplement Recall after Discovery of Undeclared Drug Ingredients

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On May 18, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release announcing the voluntary recall of certain dietary supplements marketed as male enhancements. West Coast Nutritionals, Ltd., the firm responsible for the supplements, initiated the recall after an FDA laboratory analysis uncovered the presence of undeclared Tadalafil in an assortment of the Company’s products. Tadalafil is the active ingredient in Cialis, the popular drug approved by the FDA to treat Erectile Dysfunction (“ED”). Because of the presence of the undeclared pharmaceutical ingredient, the FDA warns that the Company’s products are considered unapproved new drugs under the…
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FDA Expands Use of Device to Detect both Viral and Bacterial Causes of Respiratory Infection

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On May 15, 2012, the U.S. Food and Drug Administration (“FDA”) announced the clearance of expanded uses for the FilmArray Respiratory Panel, a medical device used to detect causes of respiratory infection. Manufactured by Idaho Technology, Inc., the device is cleared for the simultaneous detection of both viral and bacterial causes of respiratory infection. The device was originally cleared by the FDA in 2011 to detect only viral causes of respiratory infection. Now, with the expanded panel, the device is cleared to concurrently detect 17 viruses and three bacteria. The FDA’s regulation of medical devices follows a three-tier approach. Class…
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FDA and FAAN Aim to Educate Public during Food Allergy Awareness Week

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This week (May 13 – May 19, 2012) is recognized as Food Allergy Awareness Week (“FAAW”). FAAW was created by the Food Allergy & Anaphylaxis Network (“FAAN”), a non-profit organization dedicated to promoting awareness food allergies and those who suffer from them. An annual event since 1998, FAAW began at a time when companies were not required to declare major food allergens in labeling. In 2004 Congress passed the Food Allergen Labeling and Consumer Protection Act (“FALCPA”), thereby giving the U.S. Food and Drug Administration (“FDA”) the authority to regulate in this area. Since the passage of FALCPA, the FDA…
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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 Announces Recall of Alfalfa Sprouts After Listeria Monocytogenes is Detected

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On May 8, 2012, the U.S. Food and Drug Administration (“FDA”) announced the recall of alfalfa sprouts produced by the company Cleveland Beansprouts Co. Discussed here, the Company is recalling the sprouts due to the possible contamination with Listeria monocytogenes. For more information about Listeria monocytogenes, please see our previous post here. Through the U.S. Department of Agriculture’s (“USDA”) Microbiological Data Program (“MDP”), state agencies cooperate with the federal government in collecting and analyzing data to protect consumers from the spread of food-borne pathogens. The sprouts, which were only distributed in Ohio and never crossed state lines, were found to be contaminated…
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More Recalls of Pet Food in Wake of Salmonella Detection

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The U.S. Food and Drug Administration (“FDA”) has announced the recall of additional pet food due to the detection of Salmonella. According to the FDA, WellPet LLC initiated the voluntary recall as a result of the bacteria being found in facility where the dog food is manufactured. While the Company notes that all dog food is tested prior to being released from the manufacturing facility and that none of the food was found to be contaminated, the recall is being initiated as a precautionary measure. Diamond Pet Foods, the company responsible for manufacturing the pet food in the WellPet recall,…
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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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FDA Approves New Orphan Drug (Elelyso) to Treat Gaucher Disease

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On May 1, 2012, the U.S. Food and Drug Administration (“FDA”) approved a new orphan drug to treat Gaucher disease. The drug, Elelyso (taliglucerase alfa), is an injection therapy used for enzyme replacement in people with the rare genetic disorder.  Gaucher disease is essentially an enzyme deficiency that causes the buildup of lipids in several organs, including the liver and kidneys. Approved specifically to replace the missing enzyme (glucocerebrosidase) in patients with a confirmed diagnosis of Type 1 Gaucher disease, the drug underwent testing and approval through the FDA’s orphan drug designation process. Pursuant to the Orphan Drug Act of…
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