11th Circuit Rules for Plaintiffs in Class Action Lawsuit Based on Economic Loss From Purchase of ‘Worthless’ Supplements Containing DMBA – an Impermissible NDI

  We previously reported on a flurry of FDA enforcement actions in 2015 based on adulteration per se, which followed years of relative inaction in the dietary supplement marketing arena outside of enforcement against products with specific health or safety concerns.  FDA’s enforcement actions included warning letters to 14 companies regarding the marketing of products … Continue Reading

Trade Associations Send Letter to All Members of Congress Urging Action on CBD in Dietary Supplements

On October 8, the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the United Natural Products Alliance – a group of trade associations representing the dietary supplement and natural products industries, sent a letter to all 535 members of Congress urging them to pass legislation that would make … Continue Reading

FDA Adds New Ingredients to Dietary Supplement Ingredient Advisory List

On June 25, Frank Yiannis, Deputy Commissioner, Food Policy and Response, Food and Drug Administration (FDA), announced via Twitter that FDA has added octopamine and N-Methyltyramine to the Dietary Supplement Ingredient Advisory List (the “List”).  Inclusion in the list indicates that FDA believes that the ingredient may not be legally marketed based on a preliminary … Continue Reading

FDA Allows Allulose to be Excluded From Sugar Declarations

On April 18, 2019, FDA released a draft guidance for industry entitled, “The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.” The guidance announces FDA’s intent to exercise enforcement discretion for the exclusion of allulose from the amount of “Total Sugars” and “Added Sugars” declared on the label and the … Continue Reading

FDA Announces New Tool to Alert the Public of Unlawful Ingredients in Dietary Supplements

As our readers may remember, earlier this year the FDA announced a plan for modernizing and strengthening dietary supplement regulation and oversight. Under the plan, the FDA stated their intent to preserve consumers’ access to lawful supplements, while also upholding the Agency’s obligation to protect the public from unsafe and unlawful products. And as part … Continue Reading

Stakeholder Comments Reflect Discontent with FDA’s Draft Guidance for Quantitative Labeling of Supplements Containing Live Microbials

FDA’s regulation on nutrition labeling of dietary supplements requires that dietary ingredients for which a Reference Daily Intake (RDI) or Daily Reference Value (DRV) has not been established must be listed inside the Supplement Facts label along with their quantitative amount by weight per serving in metric units, as described in 21 CFR 101.36(b)(3).  For … Continue Reading

FDA oversees destruction and recall of kratom products

On February 21, FDA issued a press release announcing the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity The manufacturer of the products, Divinity Products Distribution, has also agreed to stop selling all products containing kratom … Continue Reading

FDA Announces October Meeting on Pre-DSHEA List

Manufacturers or distributors of new dietary ingredients (NDIs) must submit a pre-market notification called a new dietary ingredient notification (NDIN) to FDA at least 75 days before marketing a dietary supplement that contains an NDI (i.e., one not marketed in the U.S. prior to October 15, 1994).  On August 12, 2016, FDA issued a revised Draft Guidance on … Continue Reading

Supplement Spotlight: FDA Revised NDI Draft Guidance Does Not Alleviate Industry’s Concerns

As previously reported on this blog, FDA issued a revised Draft Guidance titled, “Dietary Supplements: New Dietary Ingredient [NDI] Notifications and Related Issues,” in August 2016. The Agency received more than 7,000 comments on the draft guidance by the Dec. 12, 2016, due date. The Dietary Supplement Health and Education Act (DSHEA) requires the manufacturer … Continue Reading

Supplement Spotlight: FDA Revises NDI Draft Guidance

FDA issues long-awaited revised Draft Guidance on new dietary ingredient notifications (NDINs) for dietary supplements. The Dietary Supplement Health and Education Act (DSHEA) requires the manufacturer or distributor of a new dietary ingredient (NDI) to submit a pre-market notification called a new dietary ingredient notification (NDIN) to FDA at least 75 days before marketing a dietary … Continue Reading

Supplement Registry Update

Leading dietary supplement trade association makes strides in developing product registry. As previously covered on this blog, a leading dietary supplement trade association — the Council for Responsible Nutrition (CRN) — has been pursuing the goal of creating a Voluntary Product Registry for Dietary Supplements.  According to CRN, the goal of the registry is to increase … Continue Reading

Supplement Stimulant Spotlight

FDA warns companies marketing dietary supplements that contain methylsynephrine. As previously covered on this blog, FDA has the authority to take enforcement action against unlawfully marketed and/or dangerous dietary ingredients in dietary supplements.  In the last year, FDA has taken action against beta-methylphenethylamine (BMPEA), 1,3-Dimethylbutylamine (DMBA), and kratom, to name a few prominent examples. FDA recently sent Warning … Continue Reading

Supplement Label Roll Call

Leading dietary supplement trade association to require all members to submit product labels to centralized database. As previously covered on this blog, a leading dietary supplement trade association — the Council for Responsible Nutrition (CRN) — has been pursuing the goal of creating a Voluntary Product Registry for Dietary Supplements.  According to CRN, the goal of … Continue Reading

Kratom Crackdown

FDA announces seizure of dietary supplements containing kratom. FDA has many tools in its arsenal to protect the public from adulterated, misbranded, and/or dangerous food and dietary supplement products; these include the Agency’s inspection power and various enforcement authorities (e.g., Warning Letters, mandatory recall orders in class I situations, administrative detention, seizure, suspension of facility … Continue Reading

Dietary Supplement Database Development

Leading trade association plans to develop voluntary dietary supplement registry. Under the Federal Food, Drug, and Cosmetic Act, FDA has the authority to regulate dietary ingredients and dietary supplements.  Although these substances and products are a subset of the “food” category, they are subject to a distinct regulatory regime under the framework of the Dietary … Continue Reading

DMAA Still For Sale

DMAA still available despite FDA’s “ban.” In 2013, FDA took enforcement actions that resulted in an effective ban on the marketing of DMAA — a stimulant linked to high blood pressure, cardiovascular problems, and even heart attacks.  In taking action against DMAA, FDA specifically noted that it had not undertaken the “lengthy scientific and legal … Continue Reading

Supplement Spotlight

FDA suggests willingness to acknowledge dietary supplement GMP compliance and hints that revised NDI draft guidance may be coming soon. FDA has regulatory authority over dietary supplements and dietary ingredients.  In recent years, the industry has grappled with negative publicity regarding compliance with the dietary supplement good manufacturing practices (GMPs) set forth in 21 CFR Part … Continue Reading

Ephedra Epilogue

Researchers report effectiveness of FDA ban on ephedra. In the 1990s and early 2000s, ephedra-based dietary supplements were widely marketed and consumed as stimulants and weight loss aids in the United States.  Ephedra consumption was linked to various serious adverse health effects, including heart attack, stroke, seizure, high blood pressure, and cardiac arrhythmia.  In certain … Continue Reading

Down on DMBA

FDA issues flurry of Warning Letters to companies marketing DMBA as a dietary ingredient in dietary supplements. By law, a “dietary ingredient” is defined as a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by humans to supplement the diet by increasing the total dietary intake; or … Continue Reading


FDA takes enforcement action against BMPEA. In recent weeks, we have seen increased media coverage regarding concerns about beta-methylphenethylamine (BMPEA) in dietary supplements in the United States.  Congressmen have urged FDA to take enforcement action and a major supplement trade association has imposed a “no-sale” policy for BMPEA supplements as a condition of membership.  Many have … Continue Reading

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