News & Analysis as of

Manufacturers Safe Harbors

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

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On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Perkins Coie

Washington Department of Ecology's Interim Policy on Lead in Cosmetics

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The Washington State Legislature passed the Toxic-Free Cosmetics Act (TFCA) in 2023, which restricts the sale of cosmetic products containing certain chemicals, including lead and lead compounds. Effective January 1, 2025,...more

Buchalter

Proposition 65 Warning Regulations Revised, Including Widely-Used Short-Form Warning

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California’s Office of Environmental Health Hazard Assessment (“OEHHA”) has revised the regulations on “Safe Harbor” warning language effective January 1, 2025. While a business is not required to use these Safe Harbor...more

Baker Donelson

Changes to California Proposition 65 "Safe Harbor" Warnings to Impact Manufacturers and Internet Retailers

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California's Proposition 65 regulations are changing January 1, 2025. Proposition 65, enacted in November 1986, requires companies to provide clear and reasonable warnings to California consumers regarding exposures to...more

Morgan Lewis

California Updates Proposition 65’s Short-Form Safe Harbor Warnings

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The California Office of Environmental Health Hazard Assessment recently approved an amendment to the so-called “short-form” safe harbor warnings under the state’s Proposition 65 law. The changes will alter the regulations...more

Venable LLP

New Center for Veterinary Medicine Final Guidance: Will AAFCO Animal Feed Ingredient Definitions Continue to Be a Safe Harbor for...

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The FDA Center for Veterinary Medicine released the Final Guidance for Industry today for its enforcement policy for AAFCO-defined animal feed ingredients. The big news is that FDA will no longer be reviewing the annual list...more

Foley & Lardner LLP

BIOSECURE Act: Anticipated Movement, Key Provisions, and Likely Impact

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Last night, the House of Representatives passed the BIOSECURE Act (BIOSECURE or the Act) by a bipartisan vote of 306 to 81.  The BIOSECURE Act prohibits federal agencies from procuring or obtaining any biotechnology...more

K&L Gates LLP

California's Updated Proposition 65 Regulations New Short-Form Warnings and More

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Longtime efforts by the California Office of Environmental Health Hazard Assessment (OEHHA) to amend the so-called “short-form” safe harbor warnings for California’s Proposition 65 appear to be nearing completion. On 13 June...more

Alston & Bird

California Modifies Proposed Amendments to Proposition 65’s Warning Requirements

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Our Environment, Land Use & Natural Resources Group explains the updates the California Office of Environmental Health Hazard Assessment plans to make to the proposed changes to California’s Proposition 65 safe harbor warning...more

Latham & Watkins LLP

IRS Safe Harbor Eases Path for Domestic Content Bonus Tax Credits

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IRS Notice 2024-41 provides taxpayers with a clearer path toward qualifying for domestic content bonus tax credits through a new elective safe harbor....more

Troutman Pepper Locke

Treasury and IRS Issue Additional Domestic Content Guidance Under IRA and New Elective Safe Harbor

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On May 16, the Treasury Department (Treasury) and the Internal Revenue Service (IRS) issued Notice 2024-41, which modifies Notice 2023-38 (Prior Guidance) by expanding the list of Applicable Projects (defined below) to...more

Troutman Pepper Locke

California Considers Modifying Prop 65 Warning Requirements (Again)

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In 2021 we wrote about the California Office of Environmental Health Hazard Assessment’s (OEHHA) plans to amend regulations governing Proposition 65 (Prop 65) short-form warning labels. On May 20, 2022, however, OEHHA...more

Alston & Bird

New Changes to Proposition 65’s Warning Requirements Are on the Horizon

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Our Environment, Land Use & Natural Resources Group explains proposed changes to California’s Proposition 65 safe harbor warning language....more

BakerHostetler

Overview and Observations of Notice 2023-38 - Domestic Content Bonus Requirements

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On May 12, 2023, the Internal Revenue Service (IRS) issued initial guidance in the form of the Notice that provides taxpayers with preliminary guidance relating to the application of the domestic content bonus requirements...more

Holland & Knight LLP

Break Out Your Calculator: IRS Releases Domestic Content Bonus Credit Guidance

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Following the release of energy community bonus credit and low-income community bonus credit guidance, the U.S. Department of the Treasury and IRS recently provided taxpayers with the domestic content bonus credit guidance....more

Sheppard Mullin Richter & Hampton LLP

Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS

Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA’s Final Rule on Intended Use: ‘Getting Right Back to Where We Started From’

On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more

Greenberg Glusker LLP

The Ever-Shifting Landscape of Prop 65 Acrylamide Regulation

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It has thus far been a noteworthy year for acrylamide, a Proposition 65-listed substance that naturally forms in the cooking and heating of many plant-based foods. Both the courts and the California Office of Environmental...more

Stoel Rives LLP

Prop 65 Changes Coming That Could Cause Headaches For Businesses

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If you sell goods in the State of California, you are probably familiar with Proposition 65 (“Prop 65”), which requires businesses to provide a warning before they “knowingly and intentionally expose any individual to a...more

Robinson+Cole Manufacturing Law Blog

California Regulators Propose New Regulations to Limit Use of “Short Form” Proposition 65 Warnings

Proposition 65 is the California law that requires warning labels on products sold to California customers that potentially expose users to certain chemicals which may cause a risk of cancer or reproductive harm. ...more

ArentFox Schiff

New Safe Harbors Offer Opportunities for Innovative Arrangements, Including Digital Health

ArentFox Schiff on

Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more

Greenberg Glusker LLP

WARNING: Ability to Use Proposition 65 Short-Form Warnings May be Short Lived

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The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed significant changes to the Proposition 65 warning requirements that may impact businesses’ Proposition 65...more

Bergeson & Campbell, P.C.

Proposition 65: OEHHA Proposes Significant Changes to “Short-Form” Warnings

On January 8, 2021, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed significant revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form”...more

Morgan Lewis

California Proposes Changes to Proposition 65 Short-Form Safe Harbor Warnings

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Proposition 65 mandates that companies doing business in California provide warnings about exposures to chemicals listed as known to the state to cause cancer or reproductive toxicity. The California Office of Environmental...more

McGuireWoods LLP

The Long and Short of It: Changes Proposed to Prop 65 Safe Harbor Warning Requirements

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Businesses selling consumer products in California should be aware that California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed substantial changes to Proposition...more

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