Tag Archives: DIETARY SUPPLEMENTS

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

Extension to Vinpocetine Comment Period Requested

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 The Natural Products Association has asked FDA to extend the comment period deadline concerning the regulatory status of vinpocetine until September 6, 2017. Vinpocetine is a semisynthetic derivative of the vinca alkaloid vincamine, an extract from the lesser periwinkle plant.  Dietary supplements containing vinpocetine as a dietary ingredient have been on the market for roughly 20 … Continue Reading

FDA Requests Comments on Regulatory Status of Vinpocetine

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FDA has requested comments on its “tentative conclusion” that vinpocetine is not eligible for use as a dietary ingredient. Vinpocetine is a semisynthetic derivative of the vinca alkaloid vincamine, an extract from the lesser periwinkle plant.  Dietary supplements containing vinpocetine as a dietary ingredient have been on the market for roughly 20 years, although not without … Continue Reading

Supplement Spotlight: FDA Revises NDI Draft Guidance

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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

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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

Barcoding Brouhaha

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New studies question use of DNA barcoding to authenticate botanical dietary supplements. In 2015, the New York Attorney General (NY AG) launched a high-profile investigation into the marketing of botanical dietary supplements, culminating in backlash against herbal supplements and a landmark settlement with a major supplement retailer.  However, the NY AG investigation was mired in controversy … Continue Reading

Supplement Stimulant Spotlight

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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 SOI Snafu Solved

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FDA updates dietary supplement labeling guidance to confirm “dietary supplement” as appropriate SOI. In April 2005, FDA issued a guidance document entitled, “A Dietary Supplement Labeling Guide.”  The guidance covers the most frequently raised questions related to dietary supplement labeling in a Q&A format, and for years, it has served as a resource for the … Continue Reading
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