If your business sells or distributes products or devices by claiming that the products work against or kill COVID-19, beware that such claims are subject to regulatory oversight by a variety of governmental agencies, such as the Environmental Protection Agency, Federal Trade Commission, and the Food & Drug Administration. Unsuspecting companies in the sale and distribution of these products, such as disinfectants, sanitizers, or cleaners,[1] must ensure their labels and marketing claims satisfy regulatory requirements.
Latest Posts
| 09.28.2020 |
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| 09.21.2020 |
In late 2018, California passed a new law that will, in the near future, present sweeping changes to the pharmaceutical industry and certain medical device manufacturers. The new law amends the existing California Integrated Waste Management Act and is expected to be a boom for medical waste disposal companies who stand to obtain significantly more business. While the law was signed by the California Governor nearly two years ago, the regulations will go into effect in a few months (by January 1, 2021). The original bill, dubbed the “California Sharps and Drug Takeback Bill”, requires a manufacturer of covered drugs or home-generated sharps waste, to offer safe disposal methods for their customers’ used and unused products. The law has potentially sweeping affect because it encompasses all covered drugs and home generated sharps waste that are sold or offered for sale in California. |
| 08.27.2020 |
On August 26, 2020, the U.S. Securities and Exchange Commission (SEC) announced significant changes to the disclosure requirements for publicly traded companies under Regulation S-K. Businesses that receive monetary sanctions from the EPA and other governmental authorities involving violations of environmental laws will want to carefully review the new Item 103 Legal Proceedings rules as it may substantially alter disclosure obligations. |
| 08.07.2020 |
Facility owners and operators with air permits will want to pay close attention to a recent Fifth Circuit ruling on a private citizen’s ability to seek penalties for/and defenses against alleged violations of the Clean Air Act. Following a bench trial, an appeal, and another bench re-trial, this decade-old case has again gone up to the appeals court and had the trial court’s judgment vacated and remanded, this time to decide the Plaintiffs’ standing to bring the case in the first place and to judge the viability of two key affirmative defenses. Environment Texas Citizen Lobby, Inc. v. Exxon Mobil Corp., 66 F.Supp.3d 875 (S.D. Tex. 2014), vacated and remanded, 824 F.3d 507 (5th Cir. 2016), on remand, No. H-10-4969, 2017 WL 2331679 (S.D. Tex. Apr. 26, 2017), vacated and remanded, slip op. No. 17-20545, 2020 WL 4345337 (5th Cir. Jul. 29, 2020), as revised (Aug. 3, 2020). According to the majority opinion, the panel gave both the lower court and the regulated community guidelines for when each CAA violation is “fairly traceable” to a plaintiff’s alleged injury to support standing under Article III of the U.S. Constitution. According to the concurrence, the Fifth Circuit’s standing precedents are “a mess” that are trending toward the unconstitutional elimination of “but-for” causation; a paradox that should be clarified by the full court en banc to stop a continuing loop of confusion. |
| 07.27.2020 |
Employers beware, particularly those in healthcare sectors. If you provide a NIOSH-approved N95 “respirator” to protect employees from COVID-19, there are a number of OSHA respiratory protection standards that must be followed in a comprehensive Respiratory Protection Program. The Department of Labor OSHA’s July 21, 2020, national press release makes clear that OSHA will seek the maximum possible penalties for serious violations against companies that do not fully satisfy the respiratory protection standards. |
| 07.07.2020 |
In a one paragraph, unsigned order issued July 6, 2020, the U.S. Supreme Court reinstated most uses of the U.S. Army Corps of Engineers’ Nationwide Permit 12 for pipeline and utility trenching and construction, dredge and fill, and maintenance, inspection, and repair activities in or adjacent to wetlands and other waters of the United States. The Court’s order carves out and continues to disallow use of NWP 12 for the Keystone XL pipeline (the actual target of plaintiffs’ lawsuit). For our earlier alerts on this fast-moving litigation see here, and here, and here. |
| 06.29.2020 |
Accidental chemical releases in the workplace and offsite into the environment continue to be a high-priority enforcement area for both the U.S. Environmental Protection Agency and the U.S. Department of Labor’s OSHA, including releases of anhydrous ammonia and other toxic and flammable substances under the agencies’ RMP and PSM programs. |
| 06.23.2020 |
California Judge Denies Nationwide InjunctionThis is an updated version of a previous blog to include recent developments. Something to do during lock-down: track the twists and turns of the multiple court challenges to the Waters of the U.S. (WOTUS) rule; a fascinating pass-time. |
| 05.28.2020 |
The partial vacation of Nationwide Permit 12 (NWP 12) will remain in place for now as the Ninth Circuit today denied emergency motions for a partial stay pending appeal. In its May 28, 2020, Order (available here) the Ninth Circuit held that appellants “have not demonstrated a sufficient likelihood of success on the merits and probability of irreparable harm to warrant a stay pending appeal.” |
| 05.28.2020 |
This is an updated version of a previous blog to include recent developments. On May 22, 2020, Colorado joined the surge of lawsuits challenging the Waters of the United States (“WOTUS”) rule issued in April by the Trump administration. See the link below to the Colorado lawsuit filed in federal court in Colorado as well as links to other similar lawsuits in other jurisdictions. |