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Publication
Keeping your dawn raid guidance current
Unannounced inspections or ‘dawn raids’ are used by antitrust authorities to obtain evidence when there are suspicions that individuals or businesses have infringed the antitrust rules.
Global | Publication | December 2017
On October 10, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb spoke at the Wall Street Journal Global Food Forum (“Forum”) and shed light on his views regarding food labeling.
Specifically, Dr. Gottlieb said that he wants FDA to take a closer look at the health claims on food packaging. He further expressed that FDA should take greater initiative in scrutinizing these claims because he is concerned that certain food manufacturers put claims on products as marketing techniques, rather than the products actually having substantiated consumer health benefits as stated in these claims, which is the regulatory requirement.
Also at the Forum, Dr. Gottlieb emphasized that FDA is looking at how to more uniformly define the terms “healthy” and “natural” on food packaging. These terms have been the subject of recent lawsuits, particularly in California, due to growing consumer health and labeling concerns.
Dr. Gottlieb also discussed the status of the Food Safety Modernization Act (“FSMA”), which we’ve discussed at length on this blog since it was signed into law by President Obama on January 4, 2011. The law provides FDA with heightened oversight of produce and imported foods, aiming to avert outbreaks of food-borne illnesses. According to Dr. Gottlieb, FDA has allowed companies more time to comply with some parts of the law, such as new produce inspections and monitoring of water supplies on farms. FDA has announced a similar compliance extension for the Nutrition Facts Label rule. However, Dr. Gottlieb said that FDA still intends on implementing these laws in the future.
There has been much speculation that Dr. Gottlieb is high on the president’s list to succeed Tom Price as the head of the U.S. Department of Health and Human Services (“HHS”), after Price’s recent resignation. When asked during the Forum whether he might be a candidate for HHS, Dr. Gottlieb said he can best serve the administration in his current role at FDA, but will serve the president in whatever capacity he is needed. To date, FDA has essentially been the only agency that has been successful in accomplishing objectives under this administration; if Dr. Gottlieb transfers from FDA to HHS, it will be interesting to see whether and how that changes.
Publication
Unannounced inspections or ‘dawn raids’ are used by antitrust authorities to obtain evidence when there are suspicions that individuals or businesses have infringed the antitrust rules.
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