Tag Archives: DIETARY SUPPLEMENTS

FDA Announces Modernization of NDIN Electronic Submission System

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FDA has announced that it is launching a new electronic submission system for New Dietary Ingredient Notifications (NDINs) on Friday, September 6.  The new system, the CFSAN Online Submission Module (COSM) is replacing the current FDA Unified Registration Listing System (FURLS).   NDINs are required to be submitted to FDA at least 75 days before marketing … Continue Reading

FDA Exploring Additional Regulatory Pathways for CBD Products

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In testimony before the U.S. Senate Committee on Agriculture, Nutrition, and Forestry on July 25, FDA’s Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., reiterated that FDA “is committed to advancing hemp products through the Agency’s existing regulatory pathways.” She added that the Agency is “further exploring whether it would be appropriate to make additional regulatory … Continue Reading

FDA Reiterates That Scientific Data and Safety Information are Required to Support a Regulation or Formal Enforcement Discretion Policy on the Use of CBD in Foods

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  Many businesses are already capitalizing on a surge in the popularity of cannabidiol (CBD) products and are pressuring the Food and Drug Administration (FDA) for a regulatory path to enable the lawful use of CBD in foods and dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Industry wants FDA to … Continue Reading

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

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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

FDA Announces New Steps to Advance Regulatory Framework for CBD Products

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Interest in products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD) has been high for the past couple of years and only increased when Congress passed the 2018 Farm Bill in December 2018.  Among other things, the law established a category for “hemp,” defined as cannabis (Cannabis sativa L.), and derivatives of cannabis (e.g., … Continue Reading

FDA Takes Action on Dietary Supplements Claiming to Treat Alzheimer’s Disease and Other Serious Conditions

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FDA has issued warning letters and online advisories to a number of dietary supplement companies whose products claim to prevent, treat, or cure Alzheimer’s disease and other serious conditions.  The disease claims cause the supplements to be considered unapproved new drugs that violate the Federal Food, Drug, and Cosmetic Act. The products in question include … Continue Reading

FDA to Strengthen Dietary Supplements Regulation

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On February 11, FDA Commissioner Scott Gottlieb, M.D. announced a new plan for modernizing and strengthening dietary supplement regulation and oversight. In making the announcement, Dr. Gottlieb pointed out that supplement use is increasing with three out of every four American consumers taking a dietary supplement on a regular basis. Also, since Congress passed the … Continue Reading

In Light of 2018 Farm Bill, FDA Issues Statement on Use of CBD in Food; Completes Evaluation of 3 Hemp-Related GRASNs

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The Agriculture Improvement Act (also known as “the 2018 Farm Bill”) was signed into law on December 20, 2018.  Among other things, the law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis (e.g., CBD) with extremely low (less than 0.3% on … Continue Reading

Contrary to Popular Reports, Farm Bill Will Not Affect FDA Status of CBD

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Media outlets are reporting that a Farm Bill provision removing industrial hemp (Cannabis sativa L.) from Schedule I of the Controlled Substances Act will change the FDA status of cannabidiol (CBD) in foods.  However, the relevant provisions under Subtitle G (“Hemp Production”) affect only the Drug Enforcement Administration’s (DEA’s) authority over hemp farming and allow states to … Continue Reading

FDA Finds High Levels of Heavy Metals in Kratom Products

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In a press announcement released on November 27, 2018, FDA Commissioner Scott Gottlieb revealed that FDA scientists found “disturbingly” high levels of heavy metals in kratom products. Kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. Kratom has opioid properties and stimulant-like effects, … Continue Reading

FDA Action Against Dietary Supplements Containing Tianeptine Signals Renewed Focus on Protecting Consumers from Dietary Supplements with Unauthorized Drug Claims

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  The Dietary Supplement Health and Education Act of 1993 (DSHEA) was intended to provide a framework for FDA to regulate dietary supplements.  DSHEA established a new category of permitted claims for dietary supplements called “statements of nutritional support.”  Claims of mitigating or treating a disease, however, are “drug claims” and are not permitted on … Continue Reading

FDA Announces Continued Kratom Safety Concerns and Issues Warning Letters to Kratom Marketers

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In a press announcement released on September 11, 2018, FDA Commissioner Scott Gottlieb, M.D., emphasized the Agency’s continuing concerns about kratom products. Our readers may remember our previous posts about kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. According to FDA, there … Continue Reading

FDA Warns Companies Illegally Marketing Dietary Supplements as Sunscreen

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On May 22, 2018, FDA sent warning letters to companies illegally marketing dietary supplements that make unproven drug claims about sun protection without meeting FDA’s standards for safety and effectiveness. FDA said the companies are “putting people’s health at risk by giving consumers a false sense of security that a dietary supplement could prevent sunburn, … Continue Reading

FDA Targets Highly Concentrated Caffeine in Dietary Supplements

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As previously reported on this blog in 2015, FDA warned that it intended to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.” The Agency made this announcement shortly after sending Warning Letters to five companies that distributed pure powdered caffeine. In the letters, FDA stated that it concluded that … Continue Reading

FDA Issues First Ever Mandatory Recall Order for Kratom Products

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On April 2, 2018, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella. FDA issued the recall after the company failed to cooperate with FDA’s request to conduct a voluntary recall. This is FDA’s first ever mandatory … Continue Reading

FDA oversees destruction and recall of kratom products

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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

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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

FDA Launches “Organ Chip” Project to Support Food and Dietary Supplement Safety Research

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“Organs-on-Chips” technology has been the focus of a public-private collaboration between FDA, the federal Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH).  “Organs-on-Chips” essentially involves creating miniature-sized human organ systems on micro-engineered chips about the size of an AA battery.  This technology has revolutionized the manner in which scientists can study the … Continue Reading

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

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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
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