Tag Archives: DIETARY SUPPLEMENTS

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

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

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

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

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

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

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

“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

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

 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

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

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

Barcoding Brouhaha

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

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

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

Cannabidiol: (Clinical) Trials and Tribulations

FDA issues Warning Letters to eight companies marketing cannabidiol products. As previously covered on this blog, FDA released a 2015 Q&A document stating its views that cannabidiol (CBD) products are excluded from the dietary supplement definition due to the existence of known substantial clinical investigations on this substance.  This is the so-called “drug exclusion” from … Continue Reading

Ask Your Doctor About…Supplements

New Jersey amends law to facilitate distribution of dietary supplements by physicians. In recent years, the dietary supplement industry has grappled with concerns about regulation and enforcement action at the state level.  In terms of state-specific regulation, New Jersey law prohibited physicians from distributing more than a 7-day supply of any drug and imposed pricing … 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

Happy New(s) Year

We welcome our readership back with a wrap-up of recent news items of interest: Vermont authorizes independent organizations to provide “non-GM” verification In anticipation of the upcoming July 1, 2016 effective date for Vermont’s GM labeling requirements, the state Attorney General has authorized two independent organizations to provide verification that food has not been knowingly … Continue Reading

“Snake Oil” Sweep

Sweeping federal probe leads to numerous charges against dietary supplements makers. (subscription to Law360 required) Dietary supplement makers have come under fire in recent years as federal and state regulators have ramped up efforts to weed out fraudulent dietary supplements from the marketplace.  As previously reported on this blog, earlier this fall, the U.S. Department … Continue Reading
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