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FDA Resets Enforcement Priorities for OTC Homeopathic Drugs
January 2, 2018 | Blog | By Joanne Hawana
Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement priorities for over-the-counter homeopathic drug products.
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A "Surprise" Cosmetic Reform Bill Appears in Congress; Bipartisan Compromise Continues to Be Legislators' Goal
November 15, 2017 | Blog | By Fatema Ghasletwala
As we predicted earlier this year, Congress is making moves toward enacting cosmetics reform legislation in the near future. In late October 2017, Senator Orrin Hatch (R-UT) introduced S. 2003, the “FDA Cosmetic Safety and Modernization Act,” which we will refer to as the "Hatch bill" for purposes of this post.
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Breaking: Republican Commissioner Mohorovic Departing the CPSC; Acting Chairman Buerkle Now Sole Republican in 3-1 Democratic Majority
October 18, 2017 | Blog
This morning at the CPSC’s public hearing Commissioner Joe Mohorovic announced that he would be resigning from his position as a Commissioner, effective Friday, October 20th.
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OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress
October 10, 2017 | Blog | By Joanne Hawana
As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter (OTC, also known as nonprescription) drug products.
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CPSC Round-Up: Buerkle Confirmation Hearing, Landmark Civil Penalty Ruling, and Partisan Action on Flame Retardants
October 6, 2017 | Blog
Over the past few weeks, there have been many key goings-on related to the CPSC and its Commissioners. First, on September 27, 2017, Acting Chairman Ann Marie Buerkle sat for a confirmation hearing before the Senate Committee on Commerce, Science, and Transportation.
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Seasoned Litigator Nominated to Replace Commissioner Robinson and Establish Republican Majority at CPSC
September 21, 2017 | Blog
Today, President Trump announced his nomination of Dana Baiocco to be a Republican Commissioner on the Consumer Product Safety Commission. If confirmed, Ms. Baiocco would take the seat of Commissioner Robinson, whose term expires on October 26, 2017.
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Food Identity Disputes Continue to Impose High-Profile Pressure on FDA
August 20, 2017 | Blog | By Joanne Hawana
As we reported on previously (see here and here), FDA recently tussled with the manufacturer of an innovative vegan condiment called “Just Mayo” based on the existence of a Federal standard of identity for mayonnaise that requires the food product to incorporate eggs.
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Reading the Tea Leaves: Sales of Macadamia Nuts Could Be Going Up!
August 9, 2017 | Blog | By Joanne Hawana
On July 24, 2017, the Food and Drug Administration announced that it had responded to a November 2015 petition from Royal Hawaiian Macadamia Nut, Inc. for a new qualified health claim characterizing the relationship between macadamia nut consumption and a reduced risk of coronary heart disease (CHD).
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California's Prop 65: More Form Over Substance
July 31, 2017 | Blog | By Daniel Herling
California’s Safe Drinking Water & Toxic Enforcement Act of 1986 (affectionately known as “Proposition 65”) has long been the subject of discussion, both pro and con. Much of the conversation is on various issues surrounding the enforcement of Proposition 65.
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President Trump Nominates Acting Chairman Ann Marie Buerkle as Permanent Chairman of the CPSC
July 24, 2017 | Blog
Today, President Donald Trump officially announced his intent to nominate Acting Chairman Ann Marie Buerkle to be the permanent Chairman of the U.S. Consumer Product Safety Commission. Her new seven year term will begin on October 27, 2018 when her first term is set to expire. If confirmed, she will become the permanent Chairman immediately and her new term will end in October 2025.
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The Turn of the “Made in America” Claim Enforcement
July 24, 2017 | Blog | By Daniel Herling
It has recently been reported that President Donald Trump is looking for ways to defend American-made products by certifying legitimate U.S. goods and aggressively going after imported products unfairly sporting the "Made in America" label, the White House said on July 18, 2017.
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CPSC to Host Recall Effectiveness Workshop; Commissioner Kaye Issues Recall Effectiveness Statement
July 20, 2017 | Blog
On July 25, 2017 at 9:00 AM, the Consumer Product Safety Commission will be hosting a public workshop on Recall Effectiveness. The workshop, to be held in the Hearing Room at CPSC Headquarters in Bethesda, Maryland, is intended to allow consumer safety professionals and the CPSC staff to discuss ways to improve the effectiveness of recalls.
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Let’s Go, Big ©! Let’s Go! U.S. Supreme Court Backs Copyright Protection for Cheerleading Uniforms
March 28, 2017 | Blog | By Susan Neuberger Weller
In a decision that may have broader implications in the U.S. fashion industry, the U.S. Supreme Court in Star Athletica, L.L.C. v. Varsity Brands, Inc. (No. 15-866) ruled that the decorative elements on a cheerleading uniform can fall within the scope of articles protectable by copyright.
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Reexamination of "Healthy" Continues with an FDA Public Meeting in March 2017
February 20, 2017 | Blog | By Fatema Ghasletwala
As we've previously reported, FDA has signaled its interest in reviewing the scope and meaning of the nutrient content claim “healthy,” in part as result of a dispute with KIND LLC about label claims for its KIND Bar products.
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CPSC Begins Transition: Ann Marie Buerkle is Now the Acting Chairman of the Agency
February 9, 2017 | Blog
This morning it was announced internally at the CPSC that Commissioner Ann Marie Buerkle has become the Acting Chairman of the agency. The CPSC has not yet released a statement concerning the transition of the chairmanship from Elliot Kaye to Ann Marie Buerkle, but we have confirmed the change in leadership with multiple sources inside the agency.
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Cosmetics Reform Activity Begins in the 115th Congress
January 26, 2017 | Blog | By Fatema Ghasletwala
As we have discussed in previous posts, Congress may be moving towards finally enacting some long-awaited cosmetics reform legislation this year. On January 13, Representative Pete Sessions (R-TX) reintroduced his cosmetics modernization bill as H.R.575.
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False Labeling Lawsuits Get Hung Up On Faulty Damages Models
January 16, 2017 | Blog | By Joanne Hawana
Some of our colleagues from Mintz Levin’s Class Action Practice, Joshua Briones, Crystal Lopez, and Grace Rosales, recently authored an interesting and timely article in the Bloomberg BNA Product Safety & Liability Reporter.
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FDA Finalizes Tobacco Product Intended Use Rules, Under a Risk of Rescission by Congress
January 12, 2017| Blog|
"Extra Sweet Pink Flesh Pineapple" - Oh My!
December 18, 2016 | Blog | By Joanne Hawana
First off, I will admit that I am somewhat of a sucker for fresh pineapple (in fact, it was my "gorging" food of choice during my pregnancies, when I could literally eat a whole pineapple in one sitting - which is embarrassing but, in my opinion, better than cravings for weird combinations like ice cream and pickles!).
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FDA Increases Transparency of Adverse Event Data for Cosmetics and Foods
December 15, 2016 | Blog | By Fatema Ghasletwala
On December 6th, FDA announced that it is publicly releasing data received by the Agency’s Center for Food Safety and Applied Nutrition (CFSAN) about adverse events related to cosmetics and foods, including both conventional foods and dietary supplements.
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