Ralph Tyler

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The Affordable Care Act (ACA) gave our nation “Obamacare.” The ACA also gave the FDA the obligation to adopt regulations requiring “a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name” to disclose the calories contained in “standard menu” items. This largely ignored ACA requirement, except by the chain restaurant industry, has yet to be implemented. It may never be. The…
As property owners shift their focus to repairing the very visible water damage to buildings and other structures, they should not lose their focus when it comes to the less apparent concerns that come with engaging contractors. Entities, like the Louisiana State Contractor Licensing Board, provide a certain level of protection to the consumer; however, caveat emptor (“let the buyer beware”) should still always be in the back of the minds of property owners…
Kim Kardashian is everywhere. But there were some bumps in the road when she took to social media on behalf of the drug company Duchesnay, Inc. to promote its morning sickness drug Diclegis. On Instagram, Ms. Kardashian breathlessly told her followers “OMG. My morning sickness has been bad. My doctor prescribed me Diclegis, and I felt a lot better.” The FDA was not impressed. It issued a warning letter saying the post is false…
The Food and Drug Administration (FDA), along with other federal authorities, has been zealous in prohibiting drug companies from making promotional statements about their drugs with respect to uses (indications) for which FDA has not granted approval. FDA’s long-held view has been that “off-label” promotion is unlawful, even if the statements are truthful and non-misleading. A new court decision casts a dark First Amendment cloud over FDA’s absolutist position. On August 7, 2015, Judge Paul…
“How Much is that Doughnut in the Window?” America has a thoroughly documented problem of too many overweight and obese people, with consequences for them and their health, the overall health of the nation, and the cost of health care.  The premise of the requirement in the Affordable Care Act that the Food and Drug Administration (FDA) adopt regulations requiring the disclosure of calories of food purchased in certain restaurants and from vending machines is…
So you’ve had a bad day — FDA has told you to stop marketing your product.  The good news, things can only get better, right?  Maybe not if a class action follows hot on the heels of FDA’s order.  This, in brief, is the recent tale of woe of 23andMe.  See Casey v. 23andMe, Inc., No. 3:13-cv-02847 (S.D. Cal. Nov. 27, 2013). The 23andMe example is only the most recent example of an FDA Warning…
The widely publicized start-up company 23andMe, Inc. markets its “personal genome service product” as providing reports on hundreds of diseases and conditions that enable users to “take steps toward mitigating serious diseases,” including diabetes, coronary heart disease, and breast cancer.  This all sounds good.  As an FDA Warning Letter issued on November 22, 2013, makes clear, however, 23andMe was marketing its product – a medical “device” under the federal Food, Drug & Cosmetic Act –…
Earlier this week the FDA unveiled its four-year plan to meet seven strategic program goals by 2016. The plan calls out the increasing challenges of the FDA’s food safety, nutrition, and animal health activities, while globalization, advances in science and technology, and shifts in consumer expectations drive change in the food and drug marketplaces. Two of the plan’s seven goals are of special interest to food marketers and advertisers. Program Goal Four seeks to increase the accuracy and…