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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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FDA Approves Drug for Treatment of Plague Through Animal Efficacy Rule

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On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) approved Levaquin (levofloxacin), a drug used to treat those afflicted with plague. In addition to treating those with the deadly infection, Levaquin is also approved to reduce the risk of contracting plague after exposure to Yersinia pestis, the bacteria responsible for causing the disease. Although the FDA estimates that only 1,000 to 2,000 people worldwide contract the infection each year, the Agency is interested in expanding available treatment options for the disease based on its belief that it could potentially be used as a bioterrorism agent in the future.…
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FDA Warns Companies Marketing Supplements Containing DMAA

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On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to several dietary supplement manufacturers in connection with their alleged improper marketing of supplements containing dimethylamylamine (“DMAA”). DMAA, also referred to as geranium extract, is an ingredient found in many dietary supplements and is frequently marketed as a natural stimulant. As discussed in the FDA’s announcement, the Agency considers the marketing of products containing DMAA improper because the ingredient has not been proven to be safe for consumers. Accordingly, these products are considered adulterated under the Federal Food, Drug and Cosmetic Act (“FFDCA”). Under the FDA’s…
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FDA Approves Vivus Inc.’s Stendra to Treat Erectile Dysfunction

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On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) approved the drug Stendra (avanafil), a drug used to treat erectile dysfunction (“ED”). Marketed by Vivus, Inc., Stendra is intended to be taken by men on an as-needed basis approximately thirty minutes prior to sexual activity. While several drugs used to treat ED are already on the market, including Viagra (sildenafil citrate) and Cialis (tadalafil), this recent approval marks the expansion of treatment options for those with ED. Under the FDA’s regulatory regime, drug sponsors must demonstrate that a drug is safe and effective for its intended use in…
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FDA Issues Statement on USDA BSE (“mad-cow”) Case

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On April 26, 2012, the U.S. Food and Drug Administration (“FDA”) issued a statement concerning the recent announcement confirming a case of bovine spongiform encephalopathy (“BSE”). The U.S. Department of Agriculture’s (“USDA”) announcement confirming and explaining this case may be accessed here. According to the USDA, the particular cow involved was a dairy cow, and thus never had contact with any animals intended to enter the nation's food supply. BSE, more commonly known as “mad-cow disease” is a deadly neurological disease in cattle that causes degeneration in the brain and spinal cord. The disease may be spread from diseased cattle…
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FDA Publishes Global Engagement Report, Highlighting Efforts Abroad

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On April 23, 2012, the U.S. Food and Drug Administration (“FDA”) released its “Global Engagement Report,” a document detailing the various strategies undertaken by the agency to ensure that FDA-regulated products, including foods, medical devices, drugs, etc., are manufactured under the same quality and safety standards as those produced domestically. Found here, the Engagement Report acknowledges the dramatic increase in importation of FDA-regulated products in recent years. For example, according to the Agency, imported foods have nearly doubled since 2002. The Engagement Report also sets forth the efforts that the FDA is taking to ensure that these products meet federal…
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FDA Enters into Consent Decree with Seafood Processor over Alleged Manufacturing Deficiencies

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On April 11, 2012, the U.S. Food and Drug Administration (“FDA”) announced that, with the aid of the Department of Justice, it has entered into a consent decree with a California seafood processor. The consent decree precludes the company from engaging in any manufacture or distribution of fish and fish products until it has remedied certain hazardous conditions in its facilities. Yamaya USA, Inc., the company at issue, was alleged to have been preparing its fish and fish products in facilities contaminated with the pathogen Listeria monocytogenes. For more information about this bacteria, please see our previous report here. In…
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