Jack Wenik
Short Hills
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Articles by Jack Wenik
FDA Finalizes Key Parts of Its NDIN Guidance Related to Identity and Safety Information: What Dietary Supplement Companies Should Know
On October 19, 2026, the U.S. Food and Drug Administration (FDA) issued final guidance (the “Final Guidance”) on identity and safety information for New Dietary Ingredient Notifications (NDINs).
Proposed H.R. 10336 Would Balance Innovation, Access to Dietary Supplements—Yet Change the Definition
On September 10, 2026, Congresswoman Diana Harshbarger (R-TN) introduced H.R. 10336—the Dietary Supplement Innovation Act—which would modernize the U.S. Food and Drug Administration’s (FDA) drug preclusion provision to encourage pharmaceutical innovation while increasing and protecting consumer access to dietary supplements.
FDA Regulations to Establish Minimum CGMP Requirements for Manufacturing, Packaging, Labeling, and Holding of Dietary Supplements | JD Supra
On June 18, 2026, the Food and Drug Administration ("FDA") announced the submission of a proposed collection of information to the Office of Management and Budget ("OMB") pertaining to the manufacturing, packaging, labeling, or holding of dietary supplements to ensure their quality ("FDA Notice"). Written comments (including recommendations) are due to OMB by July 20, 2026.
'Made in America' claims face scrutiny under executive order
+2 Julianna Dzwierzynski,Jack Wenikand 2 more At a Glance Executive Order 14392 prioritizes Federal Trade Commission enforcement actions. Online marketplaces may face new compliance rules. Qualified claims offer a safer path for compliance. On March 13, 2026, President Trump signed Executive Order 14392, titled Ensuring Truthful Advertising of Products Claiming to Be Made in America, which broadly targets false or misleading country-of-origin claims across industries.
Is Your Product Ready to Be Listed? What the Dietary Supplement Listing Act of 2026 Means for Your Business
The Dietary Supplement Listing Act of 2026 (H.R. 8370, 119th Congress) (the “Act”), introduced in the U.S. House of Representatives on April 20, 2026, has the potential to significantly impact the dietary supplement industry. The Act proposes to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”), via a new Section 403D, and create the first mandatory FDA product-listing regime for dietary supplements.
A Closer Look at H.R. 7291: What the “GRAS Oversight and Transparency Act” Could Mean for Dietary Supplements
On January 30, 2026, Representative Michael Lawler introduced H.R. 7291, the “GRAS Oversight and Transparency Act.” H.R. 7291 is the latest congressional effort to address longstanding concerns about the federal regulatory framework governing “generally recognized as safe” (“GRAS”) designations for food-related substances.
FDA’s Office of Dietary Supplement Programs Signals Key Enforcement and Policy Priorities for the Year Ahead
During a recent industry webinar, Cara Welch, Ph.D., Director of the Office of Dietary Supplement Programs (“ODSP”) within the U.S. Food and Drug Administration (“FDA”), outlined the agency’s 2026 priorities for the dietary supplement industry. Dr. Welch’s remarks reflect both continuity in FDA’s long-standing focus areas and a push toward modernization within existing statutory authority.
FDA Signals Flexibility on Placement of the DSHEA Disclaimer | JD Supra
On December 11, 2025, the U.S. Food and Drug Administration (“FDA”) announced in a letter to the dietary supplement industry that it is actively considering requests to amend its dietary supplement labeling regulation at 21 C.F.R. § 101.93(d), which governs placement of the disclaimer required for structure/function claims under the Dietary Supplement Health and Education Act of 1994 (“DSHEA”).
Denial of Preliminary Injunction in Challenge Affirmed by Second
The Second Circuit dealt a blow to the dietary supplement industry last month as it affirmed a lower court’s decision not to temporarily pause enforcement of New York’s new restrictions on sales of certain dietary supplements to minors as legal challenges continue to proceed through the court system.
Dissecting the New FTC Final Rule That Regulates “Fake Reviews” and More | JD Supra
On August 14, 2024, the Federal Trade Commission (“FTC”) announced a new final rule aimed at regulating fake consumer reviews, testimonials, insider reviews, company-controlled websites, and fake indicators of social media influence (e.g., “likes”) (the “Final Rule”).
Dissecting the New FTC Final Rule That Regulates “Fake Reviews” and More
On August 14, 2024, the Federal Trade Commission (“FTC”) announced a new final rule aimed at regulating fake consumer reviews, testimonials, insider reviews, company-controlled websites, and fake indicators of social media influence (e.g., “likes”) (the “Final Rule”).
Dissecting the New FTC Final Rule That Regulates “Fake Reviews” and More
On August 14, 2024, the Federal Trade Commission (“FTC”) announced a new final rule aimed at regulating fake consumer reviews, testimonials, insider reviews, company-controlled websites, and fake indicators of social media influence (e.g., “likes”) (the “Final Rule”).
Nuts or Not Nuts? Second Circuit Declines to Consider Whether KIND’s Use of All-Natural Is Deceptive, Misleading
Think you’re being healthy when you reach for that KIND bar in the middle of your workday? We won’t say yes or no—since the U.S. Court of Appeals for the Second Circuit has recently declined to opine on what “all natural” means—or to hear from experts on the matter.
What ISPs Need to Know About the FCC’s Title II / Open Internet Order
On May 7, 2024, the FCC released a Declaratory Ruling reclassifying “broadband Internet access service” (“BIAS”) as a “telecommunications service” subject to the jurisdiction of the FCC under Title II of the Communications Act. It was accompanied by an Order removing BIAS from most Title II regulations and a Report and Order applying a set of Open Internet rules to BIAS providers.
FDA Releases Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements
“Master Files” are not just for PowerPoints. On April 4, 2024, the Food and Drug Administration (FDA) issued its (“Draft Guidance”).
Theodora McCormick | Natural Products Insider
Home Theodora McCormick Theodora McCormick Partner, Epstein Becker & Green Theodora McCormick is a partner in Epstein Becker & Green’s Princeton, N.J. office where she represents businesses in disputes with the government, competitors, business partners, suppliers and customers. Ms. McCormick also works with dietary supplement companies to help grow their businesses while minimizing risk, whether regulatory, competitive or from consumers.
FDA Releases Draft Guidance on New Dietary Ingredient Notification Procedures, Timelines
On March 5, 2024, the Food and Drug Administration (FDA) issued its “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry” (“Final Guidance”). The purpose of the Final Guidance is to assist manufacturers and distributors of new dietary ingredients (“NDIs”) and dietary supplements in preparing and submitting new dietary ingredient notifications (“NDINs”) to the FDA.
FDA Releases Updated Directory on Select Dietary Supplement Ingredients | JD Supra
Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and effectiveness. So how do consumers know if a product is safe, and how can manufacturers protect themselves in the case of a problem?
FDA Releases Updated Directory on Select Dietary Supplement Ingre
Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and effectiveness. So how do consumers know if a product is safe, and how can manufacturers protect themselves in the case of a problem?
FDA Releases Updated Directory on Select Dietary Supplement Ingredients
Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and effectiveness. So how do consumers know if a product is safe, and how can manufacturers protect themselves in the case of a problem?
Whose Risk? Impossibility and Frustration of Purpose in Michigan Leases
Following the COVID‑19 pandemic, many parties and jurisdictions grappled with how shutdown orders affected their private contract rights. Our commentary from March 2020 is still a good starting point for evaluating these issues.
Irish DPA to Ban Meta from Processing Personal Data for Behavioral Advertising Following EDPB Urgent Binding Decision
On October 27, 2023, the European Data Protection Board (“EDPB”) adopted an urgent binding decision instructing the Irish Data Protection Commissioner (the “Irish DPC”) to take final measures against Meta Ireland Limited (“Meta”) within two weeks and impose a ban on Meta’s processing of personal data for behavioral advertising based on the contractual necessity and legitimate interests legal bases. The ban would apply across the European Economic Area (“EEA”).
Diagnosing Health Care Podcast – Episode 71: Dietary Supplements – Navigating the Regulatory Maze [Podcast]
In this episode of the Diagnosing Health Care Podcast: The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done the same. In light of these recent actions, what challenges are dietary supplement manufacturers now facing?
Vague FDA guidance fails to provide a roadmap to dietary supplement misbranding minefield
In part one of this series, we presented the current landscape regarding misbranding in the dietary supplement space and FDA enforcement activity. Claims of misbranding related to insignificant levels of impurities and other byproducts put the dietary supplement industry in a difficult position. However, the notion that products should not contain any impurities or byproducts simply lacks any logical support.
Influencers, Brand Ambassadors and Marketers Take Note – FTC Has Finalized Updates to Its Endorsement Guides
In a previous blog, we discussed the Federal Trade Commission’s (“FTC”) proposed changes to its Guides Concerning the Use of Endorsements and Testimonials in Advertising (the “Endorsement Guides”). The Endorsement Guides are intended to help businesses ensure that their endorsement and testimonial advertising conforms with Section 5 of the FTC Act, which prohibits “unfair or deceptive acts or practices in or affecting commerce,” including false advertising.
Influencers, Brand Ambassadors and Marketers Take Note - FTC Has Finalized Updates to Its Endorsement Guides
In a previous blog, we discussed the Federal Trade Commission’s (“FTC”) proposed changes to its Guides Concerning the Use of Endorsements and Testimonials in Advertising (the “Endorsement Guides”). The Endorsement Guides are intended to help businesses ensure that their endorsement and testimonial advertising conforms with Section 5 of the FTC Act, which prohibits “unfair or deceptive acts or practices in or affecting commerce,” including false advertising.
The FTC Finalizes Changes to Endorsement Guides
In a previous blog, we discussed the Federal Trade Commission’s (“FTC”) proposed changes to its Guides Concerning the Use of Endorsements and Testimonials in Advertising (the “Endorsement Guides”). The Endorsement Guides are intended to help businesses ensure that their endorsement and testimonial advertising conforms with Section 5 of the FTC Act, which prohibits “unfair or deceptive acts or practices in or affecting commerce,” including false advertising.
The FTC Finalizes Changes to Endorsement Guides
In a previous blog, we discussed the Federal Trade Commission’s (“FTC”) proposed changes to its Guides Concerning the Use of Endorsements and Testimonials in Advertising (the “Endorsement Guides”). The Endorsement Guides are intended to help businesses ensure that their endorsement and testimonial advertising conforms with Section 5 of the FTC Act, which prohibits “unfair or deceptive acts or practices in or affecting commerce,” including false advertising.
Dietary supplement makers face ‘misbranding’ minefield, need FDA guidance
Regulation of the dietary supplement industry leaves much to be desired. While there are numerous statutes and regulations that govern industry practices, the lack of detailed FDA guidance outlining threshold levels of impurities or other byproducts leaves dietary supplement manufacturers and distributors open to potential liability for misbranding. There is seemingly no logical basis for the lack of guidance. The highly regulated pharmaceutical industry has FDA-set threshold levels for impurities.
Is Federal Trade Commission at war with the dietary supplement industry?
In an extraordinary departure from accepted political norms, on Feb. 15, 2023, Christine Wilson, a Republican-appointed commissioner at the Federal Trade Commission (“FTC”), announced her impending resignation from her post in an op-ed published in The Wall Street Journal. What made the announcement so extraordinary was her accusations that FTC Chairperson Lina Khan had dramatically altered the inner workings of the agency to stifle dissent, fairness and objectivity.
FTC’s revisions to dietary supplement advertising guidelines: More of the same
Editor’s note: This column reflects the views of the authors. In late December 2022, without prior notice or opportunity for public comment or input, the Federal Trade Commission (“FTC”) released a so-called “update” to its previous 1998 guidance document, “Dietary Supplements: An Advertising Guide for the Industry.” The “Health Products Compliance Guidance” (hereinafter “Guidelines”)has ballooned to 34 pages.
FTC Issues $150 Million Fine For Targeting Ads Based on Users’ Account Security Information
The Federal Trade Commission (FTC) and Department of Justice (DOJ) recently ordered Twitter to pay $150 million for violating a 2011 FTC order that prohibited the company from misrepresenting its privacy and data security practices. In addition to the lofty fine, the proposed order bans Twitter from profiting from the deceptively collected data.
FTC’s Proposed Changes to Endorsement Guides: Social Media, “Influencers,” Consumer Reviews, and the Impact of Advertising on Children | JD Supra
The Federal Trade Commission (“FTC”) recently announced its long awaited proposed changes to its Guides Concerning the Use of Endorsements and Testimonials in Advertising (the “Endorsement Guides”). The Endorsement Guides were first enacted in 1980 and are intended to help businesses ensure that their endorsement and testimonial advertising conforms with Section 5 of the FTC Act, which prohibits “unfair or deceptive acts or practices in or affecting commerce,” including false advertising.
Congress Proposes Federal Privacy Legislation to Preempt Certain State Privacy Laws, Hearing Scheduled for Next Week
On Friday, three of the four leaders of the Congressional committees with principal jurisdiction over privacy provided for review draft privacy legislation (the American Data Privacy and Protection Act) that if adopted would preempt certain recently-passed state privacy laws. The bill, sponsored by House Energy and Commerce Chair Frank Pallone (D-N.J.), ranking member Cathy McMorris Rodgers (R-Wash.), and Sen.
New Jersey Takes Aggressive Action Against Alleged HIPAA Violations | JD Supra
In a recent dated December 15, 2021, the Office of the Attorney General for the State of New Jersey (the “N.J. Attorney General’s Office”) announced the settlement, via consent order, of alleged HIPAA violations involving three, New Jersey based cancer treatment providers, In the Matter of RCCA MSO LLC, Regional Cancer Care Associates LLC, and RCCA MD LLC.
New Jersey Takes Aggressive Action Against Alleged HIPAA Violations
Wednesday, February 2, 2022 In a recent dated December 15, 2021, the Office of the Attorney General for the State of New Jersey (the “N.J. Attorney General’s Office”) announced the settlement, via consent order, of alleged HIPAA violations involving three, New Jersey based cancer treatment providers, In the Matter of RCCA MSO LLC, Regional Cancer Care Associates LLC, and RCCA MD LLC.
New Jersey Takes Aggressive Action Against Alleged HIPAA Violations
In a recent dated December 15, 2021, the Office of the Attorney General for the State of New Jersey (the “N.J. Attorney General’s Office”) announced the settlement, via consent order, of alleged HIPAA violations involving three, New Jersey based cancer treatment providers, In the Matter of RCCA MSO LLC, Regional Cancer Care Associates LLC, and RCCA MD LLC.
FDA’s dietary ingredient advisory list raises due process concerns
On April 16, 2019, under the guise of “modernizing the FDA’s oversight of the dietary supplement industry,” the agency announced the promulgation of a “Dietary Supplement Ingredient Advisory List.” The advisory list identifies ingredients that, according to FDA, “do not appear to be lawful” and that dietary supplement companies “may wishto avoid selling, making or distributing” products containing the ingredients. (See statement of FDA Deputy Commissioner Frank Yiannas on April 16, 2019).
The Supreme Court Rules that Disgorgement is not an Available Remedy Under the FTC Act - What Comes Next?
We blogged last October (here) about the Third Circuit’s decision in FTC v. AbbieVie Inc., holding that Section 13(b) of the Federal Trade Commission Act, which expressly gives the FTC authority to obtain injunctive relief, does not allow a district court to order disgorgement or restitution. We also noted that the Supreme Court had granted certiorari to hear an appeal of the 9th Circuit’s decision in AMG Capital Management, LLC v.
Third Circuit Rules That Disgorgement Is Not an Available Remedy Under the FTC Act | JD Supra
On September 30, 2020, the Third Circuit reversed a decision by the Eastern District of Pennsylvania ordering AbbieVie, Inc. (“AbbieVie”) and Besins Healthcare Inc. (“Besins”) to pay $448 million in disgorgement of ill-gotten profits for allegedly filing sham patent lawsuits to stifle competition. AbbieVie and Besins had filed patent infringement lawsuits against two developers of generic alternatives to its brand-name testosterone gel product AndroGel.
Third Circuit Rules that Disgorgement Is Not An Available Remedy Under The FTC Act
On September 30, 2020, the Third Circuit reversed a decision by the Eastern District of Pennsylvania ordering AbbieVie, Inc. (“AbbieVie”) and Besins Healthcare Inc. (“Besins”) to pay $448 million in disgorgement of ill-gotten profits for allegedly filing sham patent lawsuits to stifle competition. AbbieVie and Besins had filed patent infringement lawsuits against two developers of generic alternatives to its brand-name testosterone gel product AndroGel.
INSIGHT: Fake Cures and Test Kits-Scammers Target Health Care
The Department of Justice is prioritizing the prevention of fraud during the coronavirus pandemic, and health care is a particularly fertile ground for scams. There will always be unscrupulous individuals and organizations, even in health care, that seek illegitimate gains during a crisis. Below are recent fraud-fighting efforts by the DOJ and a look at what to expect in the health-care industry as this pandemic continues.
INSIGHT: Fake Cures and Test Kits-Scammers Target Health Care
The Department of Justice is prioritizing the prevention of fraud during the coronavirus pandemic, and health care is a particularly fertile ground for scams. There will always be unscrupulous individuals and organizations, even in health care, that seek illegitimate gains during a crisis. Below are recent fraud-fighting efforts by the DOJ and a look at what to expect in the health-care industry as this pandemic continues.
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