Joanne Hawana on Advertising

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 Expresses Displeasure with Consumer Products Containing Trendy Cannabis Ingredient Delta-8 THC

On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC). FDA has previously sent warning letters to...more

5/13/2022 / Advertising , Cannabidiol (CBD) oil , Consumer Product Companies , Controlled Substances Act , Coronavirus/COVID-19 , Federal Food Drug and Cosmetic Act (FFDCA) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Marijuana

Federal Appeals Court Affirms Lower Court Ruling: Drug Pricing Transparency Rule Exceeds HHS’s Regulatory Authority

A panel of federal appellate judges has sided with drugmakers by upholding a lower court ruling from 2019 that struck down a regulation proposed by the Department of Health and Human Services (HHS). In a closely watched case,...more

6/19/2020 / Advertising , Department of Health and Human Services (HHS) , Disclosure Requirements , Drug Pricing , Medicaid , Medicare , Pharmaceutical Industry , Prescription Drugs , Transparency

HHS Drug Pricing Disclosure Rule: Chance at a Renewed Life Following District Court Appeal?

Looks like the Drug Pricing Disclosure Rule may not have seen its last day in court. On August 21, 2019, the U.S. Department of Health and Human Services (HHS) filed a notice of appeal against a federal judge’s decision to...more

8/27/2019 / Advertising , Department of Health and Human Services (HHS) , Direct to Consumer Sales , Drug Pricing , Final Rules , Pharmaceutical Industry , Prescription Drugs , Price Transparency , Social Security Act , Trump Administration

FDA's Drug Centers Release New Draft Guidance on Quantitative Info in Consumer-Directed Ads

In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer (DTC) promotion of prescription drugs and biological products, the Agency is recommending that companies take...more

10/17/2018 / Advertising , Direct to Consumer Sales , Draft Guidance , Food and Drug Administration (FDA) , Prescription Drugs , Product Labels , Proposed Rules , Public Comment , Television Commercials

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

FDA Cites Drug Company for Kim Kardashian Endorsement

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more

8/13/2015 / Advertising , Celebrity Endorsements , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Kim Kardashian , Misbranding , Pharmaceutical Industry , Prescription Drugs , Social Media , Warning Letters

Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic...

For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the...more

6/24/2015 / Advertising , CEOs , False Advertising , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Misleading Statements , Off-Label Promotion , Pharmaceutical Industry , Prescription Drugs

FDA Increasing Scrutiny of Cosmetic Marketing Claims, New Agency Warnings Suggest

In addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food,...more

4/17/2015 / Advertising , FDA Warning Letters , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Warning Letters

Joanne Hawana

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