News & Analysis as of

FD&C Act

Nossaman LLP

FDA Policy for Mobile Medical Applications

by Nossaman LLP on

The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...more

Burns & Levinson LLP

CBD as a Dietary Supplement – A Potential Regulatory Avenue for Retail Hemp Operators Selling THC Extracts

by Burns & Levinson LLP on

On January 13, 2020, Representative Collin Peterson, the Chairman of the House Agricultural Committee, introduced a new bipartisan bill, H.R.5587 (Bill 5587), in the U.S. House of Representatives that would potentially...more

Goodwin

Congress Adopts Biosimilar Related Provisions in the 2020 Appropriations Act

by Goodwin on

In passing H.R. 1865, the Further Consolidated Appropriations Act, 2020 (“FCAA”), on December 20, 2019, Congress adopted a number of changes to the BPCIA that impact biosimilars.  Under the BPCIA, approved NDAs for biological...more

Mintz - Health Care Viewpoints

FDA User Fees: How Do They Work?

by Mintz - Health Care Viewpoints on

Nearly 30 years ago, the first law authorizing the Food and Drug Administration (FDA) to collect fees from drug manufacturers to expedite the review of new prescription drug applications was enacted. Since then, additional...more

Robinson+Cole Health Law Diagnosis

Bipartisan Bill for Federal Regulation of CBD in Foods and Dietary Supplements

by Robinson+Cole Health Law Diagnosis on

A bipartisan bill was introduced in the U.S. House of Representatives on January 13, 2020, that (1) would allow hemp-derived cannabidiol (CBD) to be regulated as a dietary supplement, if all of the other applicable...more

King & Spalding

Congress Holds Hearing on Current & Future Federal Cannabis Policies

by King & Spalding on

On January 15, 2020, the House Energy & Commerce Committee, Subcommittee on Health held a hearing entitled “Cannabis Policies for the New Decade.” Government witnesses testified from: • the Drug Enforcement...more

Drinker Biddle & Reath LLP

FDA Warns Companies about Processing, Distributing and Marketing Unapproved Stem Cell Products

by Drinker Biddle & Reath LLP on

The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more

Stinson LLP

CBD Industry Experiences Wave of New Consumer Lawsuits

by Stinson LLP on

The cannabidiol (CBD) industry has been on the receiving end of over a half dozen new consumer class actions in recent weeks, which is likely only the beginning for the emerging industry....more

Mintz - Health Care Viewpoints

Administration Finally Releases Proposed Drug Importation Policies for Stakeholder and Public Comments

by Mintz - Health Care Viewpoints on

At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more

Mintz - Health Care Viewpoints

Consumer Product Regulatory Priorities in 2019: An Ever-Shifting Landscape for FDA

by Mintz - Health Care Viewpoints on

This is our third year-end post for 2019 related to the Food and Drug Administration (FDA), focusing on the agency’s activities in the widely divergent area of “consumer products.” In taking a wide-lens view of the past year,...more

Mintz - Health Care Viewpoints

Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020

by Mintz - Health Care Viewpoints on

Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more

Brownstein Hyatt Farber Schreck

FDA Cracks Down on Companies Selling CBD Products

by Brownstein Hyatt Farber Schreck on

The past year has seen a veritable tidal wave of consumer product marketing claiming that cannabidiol (CBD) infused or derived products cure or treat cancer, epilepsy, anxiety, inflammation, diabetes, Alzheimer’s disease,...more

McDermott Will & Emery

What to Know About FDA’s Recent Statements on CBD

by McDermott Will & Emery on

Last week FDA issued a public release on CBD titled, “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis derived Compounds, Including CBD.” The FDA document does not...more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

by Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

Ward and Smith, P.A.

FDA Issues Warnings to 15 Companies for Illegally Selling Products Containing CBD

by Ward and Smith, P.A. on

On November 25, 2019, the U.S. Food & Drug Administration ("FDA") published a press release, published a revised Consumer Update, and announced the issuance of new warning letters to 15 companies for illegally selling and...more

Mintz - Health Care Viewpoints

First Indicators of FDA’s Policy Decision on CBD and Cannabis-Derived Ingredients: “Only Limited Data” and “Real Risks”

by Mintz - Health Care Viewpoints on

We have previously blogged about the Food and Drug Administration’s year of listening and information gathering related to products containing cannabis or cannabis-derived compounds since the 2018 Farm Bill removed “hemp”...more

Perkins Coie

FDA Declines to Conclude CBD is Safe and Sends Flurry of Warning Letters

by Perkins Coie on

On November 25, 2019, the U.S. Federal Drug Administration (FDA) took several significant actions regarding sellers of products containing cannabidiol (CBD). The FDA announced that it cannot conclude that CBD is “generally...more

Bradley Arant Boult Cummings LLP

The Beginning of the End or the End of the Beginning? The FDA Issues 15 New Warning Letters to CBD Companies - Cannabis Industry...

by Bradley Arant Boult Cummings LLP on

The U.S. Food and Drug Administration (FDA) sent a shot across the bow of the cannabidiol (CBD) industry on November 25. The FDA disclosed that it issued warning letters to 15 companies “for illegally selling products...more

Wilson Sonsini Goodrich & Rosati

FDA Declares CBD Is Not GRAS and Signals That It Will Maintain Its Deliberate Approach

by Wilson Sonsini Goodrich & Rosati on

With its recent issuance of additional warning letters and the release of a consumer update, the Food and Drug Administration (FDA) appears to be signaling that it will continue its deliberate approach in determining an...more

Arnall Golden Gregory LLP

A Very Fine Line — Split Decision: FDA Issues Draft Guidance on Clinical Decision Support Software

by Arnall Golden Gregory LLP on

From his 1986 “Back in the High Life” album, Steve Winwood sings, “It’s a fine line, a very fine line – split decision.” In fact, that’s what many medical device companies will face as they review the Food and Drug...more

Pepper Hamilton LLP

USDA Issues Rules for Hemp Production - Many Questions Remain for Hemp and CBD Sales

by Pepper Hamilton LLP on

Hemp production is a large and growing industry in the United States. Even before Congress’ passage of the Agriculture Improvement Act of 2018 (better known as the 2018 Farm Bill), the Hemp Business Journal estimated that...more

Mintz - Health Care Viewpoints

HHS Files Brief in D.C. Circuit Supporting Drug Pricing Transparency Rule

by Mintz - Health Care Viewpoints on

As promised, the Department of Health and Human Services (HHS) filed a brief in the United States Court of Appeals for the District of Columbia Circuit challenging the district court’s holding that the Secretary lacked the...more

Arnall Golden Gregory LLP

FDA Issues Final Guidance on “505(q)” Citizen Petitions, including Factors to be considered in Evaluating Potential...

by Arnall Golden Gregory LLP on

FDA recently issued final guidance for industry on citizen petitions and requests for stays of agency action that may delay the approval of certain drug and biological product applications....more

Wilson Sonsini Goodrich & Rosati

Microbes and Medical Foods: A Growing Area of Commercial Importance

by Wilson Sonsini Goodrich & Rosati on

The 2nd Annual Microbiome Movement conference, recently held in San Diego, California, highlighted the growing importance of microbes as the basis for various commercial products. Microbe-containing products regulated by the...more

Knobbe Martens

FDA Issues Guidance on “Abbreviated” and “Special” 510(k) Pathways

by Knobbe Martens on

The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices....more

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JD Supra Privacy Policy

Updated: May 25, 2018:

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Links to Other Websites

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Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

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You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

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California Privacy Rights

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You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Access/Correct/Update/Delete Personal Information

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Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

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How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

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Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.