Joanne Hawana on Labeling

FDA Warning Letter Reminds Industry that Wellness Claims Only Go So Far, Other Features Can Establish Intended Use

A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because...more

7/22/2025 / Advertising , Enforcement , Food and Drug Administration (FDA) , Labeling , Marketing , Medical Devices , Product Labels , Regulatory Authority , Warning Letters , Wellness Programs

FDA Continues Push to Improve Food Labeling Practices in the United States

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more

2/24/2025 / Compliance , Department of Health and Human Services (HHS) , Draft Guidance , Executive Orders , Final Rules , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Labeling , Proposed Rules , Public Health , Regulatory Agenda , Rulemaking Process

FDA Warns “Natural” Birth Control Company: Three Takeaways from the NOV Letter

A little over a year after the Dobbs v. Jackson Women’s Health Organization decision, the Food and Drug Administration (FDA) continues to be at the forefront of addressing reproductive health concerns. An example of this...more

8/2/2023 / Birth Control , Dobbs v. Jackson Women’s Health Organization , Enforcement , Food and Drug Administration (FDA) , Labeling , Notice of Violation , Over The Counter Drugs (OTC) , Reproductive Healthcare Issues

FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more

1/3/2018 / Advertising , Draft Guidance , Enforcement , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Homeopathic Remedies , Labeling , Marketing , Pharmaceutical Industry , Public Comment

Senate Appropriations Bill Targets FDA Rulemaking Agenda

The Senate Appropriations Committee is looking to tinker with the Food and Drug Administration’s rulemaking agenda through its fiscal year 2017 funding bill for the Department of Agriculture and FDA (S. 2956). Passed...more

6/9/2016 / Appropriations Bill , Food and Drug Administration (FDA) , Food Labeling , Labeling , Legislative Agendas , Menu-Labeling , Pending Legislation , Rulemaking Process , Salmon , USDA

FDA Differentiates Biosimilar Labeling from Generic Drug Labeling

In another highly anticipated regulatory move, FDA has released draft guidance on “Labeling for Biosimilar Products.” Made public on March 31st, the draft guidance sets forth FDA’s recommendations on the labeling of...more

4/4/2016 / Biosimilars , BPCIA , Draft Guidance , Food and Drug Administration (FDA) , Labeling , Pharmaceutical Industry

Senators to Receive Update on Biosimilar Implementation from CDER’s Woodcock

On September 17, 2015, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and...more

9/18/2015 / Biosimilars , BPCIA , Congressional Investigations & Hearings , Draft Guidance , Drug Pricing , FDA Approval , Food and Drug Administration (FDA) , Labeling , Prescription Drugs , Public Health

Joanne Hawana

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