Thursday, March 30, 2017 1:00 – 2:00 p.m. EasternAggressive 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 Indeed, many of the CPSC rules affecting product performance have been mandated by Congress and could not be repealed by the agency absent an act of Congress. Still others may require some APA process before they can be legally repealed or changed.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. EasternAggressive 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.
Please click here to register for this webinar, or click here to view the event on Crowell.com.
Key topics to be discussed:
Continue Reading Webinar: The Safety Agencies in Transition – What to Expect at FDA, CPSC and NHTSA in the First 100 Days
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.
Continue Reading Beauty with a Side of Mercury?
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.
Continue Reading A New Federal GMO Labeling Standard in the Works?
On Friday, May 20, 2016, the U.S. Food and Drug Administration (FDA) announced a “refreshed” Nutrition Facts label, which, except for the addition of trans-fats in 2006, had gone largely untouched since 1994. Consumers will not only notice an updated design, which makes the label larger and bolder, but there are more substantive changes that, according to FDA, “are based on updated scientific information, new nutrition and public health research, more recent dietary recommendations from expert groups, and input from the public.”
Continue Reading The FDA Unveils an Updated Nutrition Facts Label
The FDA is cracking down on distributors of pure powdered caffeine. On Tuesday, the agency released a statement announcing that it fully intends to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.” This is no empty threat. Warning letters were issued to five distributors of the product on August 27th. The FDA found the products to be adulterated within the meaning of the Food, Drug, and Cosmetic Act because they contain amounts of caffeine that could be lethal to consumers, and require the use of a precise scale to distinguish a “safe serving from a potentially lethal amount.” As a result, the agency concluded that the products present “a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.”
Pure powdered caffeine products are 100% caffeine and a single teaspoon is the equivalent to approximately 25 cups of coffee.
Continue Reading The FDA Issues Warning Letters to Five Distributors of Pure Powdered Caffeine
On Friday the U.S. Food and Drug Administration (FDA) sent a warning letter to Duchesnay, manufacturer of DICLEGIS, a morning sickness drug, based on a social media post by ubiquitous social media user, Kim Kardashian. Kardashian posted a picture of herself with the drug while touting its safety and efficacy. However, Kardashian failed to mention
Last week, the U.S. Food and Drug Administration (FDA) released draft guidance on its mandatory recall authority; in doing so, FDA elaborated on its authority to issue user fees. Food retailers and manufacturers should take note that in the event FDA determines that there is: (1) a reasonable probability that a food product is misbranded
On December 8 and 9, 2014, the Food and Drug Law Institute (FDLI) held its annual Enforcement, Litigation & Compliance Conference in Washington, D.C. Speakers from the U.S. Food and Drug Administration (FDA), Department of Justice (DOJ), and other federal agencies, as well as representatives from industry and the private bar, discussed recent activity and predictions for federal regulation of food, drugs, medical devices, cosmetics, dietary supplements, and tobacco in 2015.
Continue Reading Report from FDLI’s 2014 Enforcement, Litigation and Compliance Conference