Retail & Consumer Products Law Observer

Retail & Consumer Products Law Observer

Legal Insight for the Retail and Consumer Products Industry

Tag Archives: FDA

A Science-Driven Agency Makes a Science-Based Decision: FDA Acknowledges Qualified Health Claim Aimed at Preventing Peanut Allergies

Posted in Product Liability & Torts
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 of developing peanut allergy by age… Continue Reading

Join Us: ABA Food & Supplements 7th Annual Workshop

Posted in Advertising & Product Risk Management, Events, Product Liability & Torts
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 other issues confronting the food industry,… Continue Reading

The Devil is in the Details: Recordkeeping a Central Focus in FSMA Inspections

Posted in Advertising & Product Risk Management, Product Liability & Torts
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… Continue Reading

Webinar Recap: Safety Agencies in Transition

Posted in Events
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, particularly… Continue Reading

What Does The Future Hold For NHTSA?

Posted in Advertising & Product Risk Management, Events
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… Continue Reading

Join us for a webinar… The Safety Agencies in Transition – What to Expect at FDA, CPSC and NHTSA in the First 100 Days

Posted in Events
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… Continue Reading

Safety Agencies after Trump’s “2 for 1” Executive Order: What it May Mean for Regulating the Safety of IoT and other Emerging Technologies

Posted in Advertising & Product Risk Management
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… Continue Reading

Webinar: The Safety Agencies in Transition – What to Expect at FDA, CPSC and NHTSA in the First 100 Days

Posted in Events
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… Continue Reading

Beauty with a Side of Mercury?

Posted in Advertising & Product Risk Management, Consumer Class Action, Product Liability & Torts, Torts
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… Continue Reading

A New Federal GMO Labeling Standard in the Works?

Posted in Advertising & Product Risk Management, Consumer Class Action
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… Continue Reading

The FDA Unveils an Updated Nutrition Facts Label

Posted in Advertising & Product Risk Management
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,… Continue Reading

The FDA Issues Warning Letters to Five Distributors of Pure Powdered Caffeine

Posted in Advertising & Product Risk Management, Product Liability & Torts
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… Continue Reading

False-and-Misleading-Gram – FDA Issues Warning Letter Based on Kim Kardashian’s Instagram Selfie

Posted in Advertising & Product Risk Management
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 risk information… Continue Reading

Firms Could Face Stiff Penalties for Failing to Follow Recall Orders to a Tee

Posted in Advertising & Product Risk Management
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… Continue Reading

Report from FDLI’s 2014 Enforcement, Litigation and Compliance Conference

Posted in Advertising & Product Risk Management, Consumer Class Action, Product Liability & Torts
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… Continue Reading

To Label Or Not To Label? Companies May Have No Choice

Posted in Advertising & Product Risk Management, Environment & Natural Resources
Most everyone knows that the First Amendment restricts the government’s ability to limit commercial speech. Similarly, most everyone would probably think the First Amendment also restricts the government’s ability to compel commercial speech. But are there times when the government may compel commercial speech? Indeed it can in some circumstances, and the D.C. Circuit recently… Continue Reading

Sixth Round of TTIP Negotiations Concludes in Brussels

Posted in Advertising & Product Risk Management, EU Regulation, International Trade
The Transatlantic Trade and Investment Partnership (TTIP) negotiations formally commenced on July 8, 2013. A little over a year later, the negotiators have held six rounds of negotiations. The most recent round of negotiations was held during the week of July 14-18 in Brussels, and the seventh round is now expected for D.C. in late… Continue Reading

FDA Issues Definition for ‘Gluten-Free’ on Food Labels

Posted in Advertising & Product Risk Management
On Friday, August 2, 2013, the United States Food and Drug Administration (FDA) published a new regulation establishing standards for when a food product can claim to be “gluten-free.” According to the final rule, food bearing a “gluten-free” label, as well as foods claiming “no gluten,” “free of gluten” or “without gluten,” must not contain more… Continue Reading