Earlier this month, the U.S. Food and Drug Administration announced that it would allow infant food manufacturers to use a qualified health claim on their labeling to characterize the relationship between consumption of ground peanuts by infants beginning between 4 and 10 months of age and a reduced risk
2017 continues to be the year of the Food Safety Modernization Act, as the U.S. Food and Drug Administration, having completed its roll-out of the major rules implementing this land-mark food safety legislation, moves in earnest with inspections to check on compliance.
To help manufacturers prepare for this and…
The Food Safety Modernization Act, which was signed into law by President Obama on January 4, 2011, promised sweeping reform of food safety practices from farm to fork, and shifted FDA’s regulatory posture from reacting to food contamination to proactively preventing it. While the Trump administration has vowed to eliminate two regulations for every new regulation, at this year’s Food and Drug Law Institute’s Annual meeting, Dr. Susan Mayne, the Director of FDA’s Center for Food Safety and Applied Nutrition, made clear that FSMA is the law of the land and FDA fully intends to continue its implementation and enforcement of it.
On March 30, 2017, Crowell & Moring’s Advertising & Product Risk Management Group hosted a webinar in which we discussed likely changes on the horizon at the Food & Drug Administration, Consumer Product Safety Commission, and the National Highway Traffic Safety Administration. We also discussed the relationship between these agencies and the Department of Justice,…
More than two months after President Donald Trump’s inauguration, the automotive industry continues to face substantial uncertainty regarding the direction and priorities of the National Highway Traffic Safety Administration (NHTSA) over the next few years. For now, we can only guess. The new Transportation Secretary, Elaine Chao, was confirmed January 31. She takes over a NHTSA that had been working hard to keep up with emerging technologies – while acting increasingly muscular in its fines and other punishments under the prior administration.
For some safety agencies, it is much easier to read the tea leaves under the new administration. For example, at the Consumer Product Safety Commission, for example, we know that there is a new Republican Acting Chair (Ann Marie Buerkle), and that the five commissioners will remain 3-2 in favor of Democrats until at least October 2017 when Democratic Commissioner Marietta Robinson’s term on the Commission expires. See prior article here. And, following Acting Chair Buerkle’s public remarks last month at the annual conference of the International Consumer Product Health and Safety Organization (ICPHSO), we know that her top three priorities include: (1) collaborating with all product safety stakeholders; (2) taking a balanced and reasonable approach to regulation; and (3) expanding product safety education and awareness for consumers. See prior article here.
Thursday, March 30, 2017 1:00 – 2:00 p.m. Eastern
Aggressive enforcement, massive recalls and proactive safety agendas left an indelible impression on the product safety world under the Obama administration. Product safety is no longer a bipartisan affair. But what will the Trump administration mean for your regulatory compliance programs? What changes will we see…
Historically, as administrations change at the safety agencies, new priorities and shifting judgments on risk-based hazard assessment drive regulatory burdens up or down. The effect of President Trump’s executive order requiring the repeal of two rules for every one promulgated is yet to be seen when it comes to rulemaking at consumer facing safety agencies such as the National Highway Traffic Safety Administration, Food and Drug Administration, and Consumer Product Safety Commission.
The CPSC, as an independent agency, could take the position that the E.O. simply does not apply to them. The White House agrees. But the reality is that very few $100 million rules have been issued by the CPSC over the entire life of the agency. That is because its enabling statute favors voluntary industry standards over mandatory rules. Indeed, many of the CPSC rules affecting product performance have been mandated by Congress and could not be repealed by the agency absent an act of Congress. Still others may require some APA process before they can be legally repealed or changed.
Join Us for a Webinar – Thursday, March 30, 2017 1:00 – 2:00 p.m. Eastern
Aggressive enforcement, massive recalls and proactive safety agendas left an indelible impression on the product safety world under the Obama administration. Product safety is no longer a bipartisan affair. But what will the Trump administration mean for your regulatory compliance programs? What changes will we see and how will they affect your safety program?
Join us for a roundtable discussion of what the regulated community can expect under the new administration at the Food & Drug Administration, Consumer Product Safety Commission and the National Highway Safety Administration. We’ll help you to forecast where policy shifts on by focusing on topical discussions of emerging products such as autonomous cars, drones, miniaturized cameras and e-cigarettes, and emerging issues including fire and lithium ion batteries, as well as hacking concerns on interconnected products.
Key topics to be discussed:…
On July 26, 2016, FDA issued an updated warning on beauty products, warning consumers to avoid certain “skin creams, beauty and antiseptic soaps, and lotions,” particularly those boasting “anti-aging” or “skin lightening” benefits, as potentially containing mercury. While the dangers of mercury exposure are well-known, mercury’s ubiquity in certain beauty products is not. Products that claim to “remove age spots, freckles, blemishes, and wrinkles,” including products targeting teenagers enduring acne, may contain mercury. Checking the label can help—look out for words like “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or of course, “mercury”, but it’s not fool-proof. As FDA points out, many of these beauty products are often made abroad and can be sold illegally in the U.S., without any labels. FDA continually monitors products like these, but is unable to catch all of them, especially due to their dubious channels of trade. For those that FDA does catch, FDA sets up an import alert to prevent future influxes of such products. Check here for all Consumer Updates from FDA. Thus, retailers should do their due diligence to know what the chemical content is of the products they sell beyond the labels.
In its warning, FDA again mentioned one of its growing complaints levied against cosmetics – that the product may actually be an unapproved new drug under the law.…
One week before the Vermont GMO labeling law will take effect, a bipartisan bill requiring mandatory labeling for products containing genetically modified ingredients has been agreed to by Senate AG committee ranking member Debbie Stabenow (D-MI) and Committee Chairman Pat Roberts (R-KS). The bill, which would require the Secretary of Agriculture to establish a national disclosure standard for bioengineered foods, will need to be passed in the Senate and the House of Representatives, and would go into effect two years after passed. If successful, the new law would specifically preempt all state GMO labeling laws and would prevent the feared patchwork of conflicting state labeling laws.
The bill has a narrow definition of genetic engineering — traits developed through in vitro recombinant DNA techniques, which could not be obtained through conventional breeding or found in nature. It excludes food served in a restaurant and food derived from animals that consumed genetically modified feed. The Secretary would be responsible for establishing a specific regulation setting forth the amount of a genetically modified substance that would require labeling.…