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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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FDA Warns Consumers of Dangers Associated with Crackers Lacking Proper Allergy Warnings

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On April 5, 2012, the U.S. Food and Drug Administration (“FDA”) issued a press release warning consumers not to eat certain crackers because of the potential dangers for those with milk or nut allergies. TWI Foods Inc., the crackers’ manufacturer (called “Rusk” brand Crispy crackers), initiated a voluntary recall of its crackers and toast, because of the undeclared allergens in product labeling. Under the Food Allergen Labeling and Consumer Protection Act of 2004 and FDA regulations, manufacturers and/or distributers of finished food products are required to declare the presence of major food allergens in labeling. “Major food allergens” include the…
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FDA Enters Into Consent Decree of Permanent Injunction with Cheese Producer Due to Listeria Contamination

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On April 9, 2012, the U.S. Food and Drug Administration (“FDA”) announced it has entered into a consent decree with a Washington State cheese producer. The company, Del Bueno, which processes and distributes cheeses, and its owner Jesus Rodriguez, agreed to the terms of a consent decree recently entered by U.S. District Judge, Lonny Suko, in the Eastern District of Washington. As part of the consent decree, Del Bueno cannot sell or otherwise distribute any food products unless and until it first proves that its goods are safe for human consumption. To this end, Del Bueno must develop a control program…
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FDA Denies Petition to Ban BPA

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On March 30, 2012, the U.S. Food and Drug Administration (“FDA”) denied a request to ban the chemical bisphenol-A, commonly known as BPA, from food and drink packaging materials. The request, made by the Natural Resources Defense Council (“NRDC”), sought for the FDA to ban the controversial substance, citing the potential for serious adverse health effects. The NDRC Petition, filed on October 28, 2008, may be accessed here. Ultimately, the FDA concluded that there is insufficient evidence to demonstrate that BPA is harmful when used in food contact materials. More information about the FDA’s efforts in response to the request…
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FDA Proposes Reclassification of Tuberculosis Tests

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On March 16, 2012, the U.S. Food and Drug Administration (“FDA”) announced its issuance of a proposed rule intended to lower the regulatory classification for nucleic acid-based tuberculosis tests. These tests, which are currently classified as Class III medical devices, are used in the detection of tuberculosis (“TB”) from a patient’s mucus (sputum) sample. With this classification downgrade, device sponsors will be able to bring devices to the market with both greater ease and less expense. In addition to the proposed rule, the FDA issued a draft guidance to aid in the transition from Class III to Class II. The…
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FDA Approves Boniva Generics

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On March 19, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of generic versions of the drug Boniva (ibandronate). Boniva, manufactured by Genentech Inc., is a once-monthly tablet used in the treatment and prevention of osteoporosis in women. These recent FDA approvals are the first allowing the sale of generic versions of Boniva. Generic drugs are approved by a process where a drug sponsor submits an Abbreviated New Drug Application (“ANDA”). In contrast to New Drug Applications (“NDAs”), an ANDA is considered “abbreviated” because the drug sponsor is typically not required to submit preclinical (animal) or clinical (human)…
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