Category Archives: Dietary Supplements

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FDA Announces Delay in Compliance Dates for Revised Nutrition Fact Requirements

The FDA announced today that it was delaying implementation of the final rule promulgated in May 2016 that revised regulations governing Nutrition Facts labels on food and dietary supplements.  The rule initially set a general compliance date of July 26, 2018, although manufacturers with annual food sales of less than $10 million were given an … Continue Reading

Oregon Attorney General Announces $545,000 Settlement with Retailer

750px-Flag_of_Oregon_svgThe Oregon AG recently announced a $545,000 settlement with the Vitamin Shoppe over allegations that the store violated Oregon state law by selling dietary supplements containing ingredients that FDA has deemed unsafe or unlawful. The new settlement agreement places significant burdens on the Vitamin Shoppe to monitor developments on ingredient status. The burdens are the same regardless of whether the … Continue Reading

State AGs and the New Administration

USA_orthographic_svgAs we discussed in recent interviews with Nutritional Outlook and Natural Products Insider, FTC enforcement against supplement companies is likely to evolve into something  much more reasonable under the new administration.  State attorney general activity, however, is likely to become more aggressive – or at least more widespread.  State regulators may perceive a need to … Continue Reading

Dietary Supplement Advertising

Dietary TwitterDid you know Kelley Drye’s Advertising Law practice produces a newsletter, Dietary Supplement Advertising, to help marketers of dietary supplements stay out in front of regulatory challenges. Click here to access our Publication Sign Up and select Dietary Supplements to subscribe. Find contents from the latest issue below: Click here to view with images. STATE REGULATION State AGs and the New Administration … Continue Reading

Identity Crisis Over: Dietary Supplements Can Be “Dietary Supplements”

In its dietary supplement labeling guide, first issued in April 2005, FDA advised that it would not consider the term, “dietary supplement,” alone, to be an appropriately descriptive “statement of identity.” FDA, however, has now reversed course. Revised guidance released last week now provides as follows: Can the term “dietary supplement” by itself be considered the … Continue Reading

FDA Targets CBD Products, Claims Made in Social Media

Last February, FDA issued three warning letters to companies marketing cannabidiol (CBD) products as dietary supplements. FDA reviewed the companies’ websites and concluded that claims that CBD products could treat post-traumatic stress disorder, lupus, cancer, and other conditions rendered the products unapproved new drugs. This February, FDA again turned its attention to CBD products, issuing … Continue Reading

The DOJ Press Conference on Dietary Supplements: Heavy on Hype, Short on Facts

On Tuesday, a nimiety of federal agencies converged at a press conference at the Department of Justice to announce new and ongoing cases against dietary supplement marketers. Federal agencies included FDA, the FTC, the U.S. Postal Inspection Service, the IRS, the Department of Defense, and the U.S. Anti-Doping Agency. The event was flush with provocative … Continue Reading

FDA on UGC

A recent warning letter suggests that FDA, in regulating user generated content (“UGC”) on social media pages, will likely treat all companies the same. Earlier this year, FDA released two guidance documents for drug and medical device companies on social media. Those documents provided the following stance on UGC: “[A] firm generally is not responsible for UGC … Continue Reading

FDA Reopens Comment Period on Final Guidance Requiring INDs for Certain Food, Dietary Supplement, and Cosmetic Studies

The FDA today published a Federal Register notice reopening the comment period on the Final Guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can be Conducted Without an IND.” FDA published the IND guidance document in draft form in October 2010. FDA then released a significantly expanded version of the … Continue Reading

Is it a Beverage or Liquid Dietary Supplement? FDA Issues Final Guidance to Help Companies Tell the Important Difference

On January 14, 2014, FDA issued final guidance to help companies determine whether a product qualifies as a “dietary supplement” or “conventional food” as defined by the federal Food, Drug & Cosmetic Act (FD&C). While dietary supplements and conventional foods are both considered “foods” under the FD&C, there are important differences in the regulatory requirements … Continue Reading

FDA Publishes Guidance on Food, Beverage, and Dietary Supplement Additives

On January 14, the Food and Drug Administration (“FDA”) published a guidance document entitled Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements, with the goal of reminding industry: (1) about the Federal Food, Drug and Cosmetic Act’s requirements governing substances added to conventional foods, including beverages; and (2) that those same requirements … Continue Reading

Highlights of FDA’s Implementation of the Food Safety Modernization Act in 2013

President Obama signed into law the Food Safety Modernization Act (FSMA) nearly three years ago. After significant delays, the FDA has made significant progress this year towards implementing this act and published five key proposed FSMA implementing regulations. These proposed regulations and related FDA enforcement policies will have far-reaching implications for how food for both … Continue Reading

FDA Releases Final Rule Defining “Gluten-Free” Foods

The Food and Drug Administration (FDA) has published its long awaited final rule defining “gluten-free” labeling requirements. Under the final rule, companies may choose to promote foods using “gluten free” labeling claims provided that the labeled foods qualify under the definition prescribed by FDA in the final rule. Under FDA’s final rule, “gluten-free” is defined … Continue Reading

OIG Recommends Significant Changes to FDA Regulation of Dietary Supplements

The Department of Health & Human Services (HHS) Office of Inspector General (OIG) has released two reports examining regulation of the dietary supplement industry, Dietary Supplements: Companies May Be Difficult to Locate in an Emergency, and Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements. Dietary supplement manufacturers should carefully review the reports because the … Continue Reading

FDA Adding New Food Categories to Food Facility Registrations under FSMA

FDA released a draft guidance today identifying additional food categories to be included as part of the mandatory registration program for any domestic or foreign facility that manufactures, processes, packs or holds food for human or animal consumption. The draft guidance acts on authority delegated by section 102 of the Food Safety Modernization Act (FSMA), … Continue Reading

Where in the World is FDA? FDA Submits Report to Congress on Foreign Programs as Required by FSMA

The Food and Drug Administration (“FDA”) has submitted its Report to Congress on the FDA Foreign Offices. Under the Food Safety Modernization Act (FSMA), FDA is required to update Congress on the agency’s progress in establishing foreign posts and working with foreign government counterparts to further FDA’s mission. Companies that import food, drugs, devices or … Continue Reading

FDA Releases Guidance on Implementation of FSMA Fee Provisions

The Food and Drug Administration (“FDA”) has released a question and answer guide to its implementation of the fee provisions of the Food Safety Modernization Act of 2011. The purpose of the fee provisions is to allow the FDA to recover reinspection, recall noncompliance, and importer program related costs from domestic and foreign facilities and … Continue Reading

FTC Seeks Comment Regarding Retail Food Store Advertising and Marketing Practices Rule

On August 18, 2011 the FTC issued a request for public comment and advance notice of proposed rulemaking (ANPR) as part of the Commission’s review of the costs, benefits, necessity, and regulatory and economic implications of its “Retail Food Store Advertising and Marketing Practices” rule, commonly called the “Unavailability Rule,” 16 C.F.R. Part 424. Currently, … Continue Reading

New Dietary Ingredient Draft Guidance Released By FDA

On Friday, the Food and Drug Administration (FDA) released a draft guidance for industry that could have far-reaching consequences for companies that market dietary supplements. The draft guidance, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, is intended to give dietary supplement manufacturers and distributors “information and recommendations to help them decide when NDI … Continue Reading

Sens. Hatch and Harkin Send Letter to FDA in Anticipation of NDI Guidance

Senators Hatch and Harkin, the principle architects of the Dietary Supplements Health and Education Act (DSHEA) (amending the Federal Food Drug and Cosmetic Act (FDCA)), submitted a letter yesterday to FDA Commissioner Margaret Hamburg "exress[ing] their support for the upcoming new dietary ingredients (NDI) guidance." The Senators stated that the guidance should reflect the intent … Continue Reading

Can We Say That? A Practical Guide to Substantiating Claims for Food and Consumer Health Products

This Monograph, published by the Food and Drug Law Institute, is designed to assist lawyers, regulatory advisors and marketing professionals answer the question "Can we say that?" as they design and execute programs to promote consumer health products such as foods, dietary supplements, non-prescription drugs and medical devices, cosmetics and pet care products. It serves … Continue Reading

New Food Safety Law Sets the Stage for Industry Participation in Numerous Rulemakings

The Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, requires the Food and Drug Administration (FDA) to undertake sweeping regulatory action to strengthen the safety of the nation’s food supply. Many of the items on FDA’s “to do” list require significant and swift action. Over the next two years, FDA must … Continue Reading

Dietary Guidelines for Americans, 2010

On January 31, 2011 the U.S. Department of Agriculture (USDA) and U.S. Department of Health and Human Services (HHS) issued the Dietary Guidelines for Americans, 2010. A copy of the executive summary is available here. Supporting documents include Questions and Answers on the 2010 Dietary Guidelines, a Backgrounder regarding the History and Process for the … Continue Reading

New Trends in Health-Related Advertising Claims

Companies marketing functional foods or dietary supplements should be aware of the Federal Trade Commission’s new regime for using health-related advertising claims and the Food and Drug Administration’s heightened scrutiny of health-related front-of-package (FOP) labeling claims. In two game-changing settlement orders, issued in July of this year, the FTC, for the first time, required that … Continue Reading
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