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
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
In a March 29, 2018 press release, the Food and Drug Administration (FDA) announced a consent decree entered by the US District Court for the Eastern District of New York for a permanent injunction against Riddhi USA and its owner, Mohd M. Alam. Riddhi USA (which is not currently manufacturing dietary supplements) is a New York based wholesale … Continue Reading
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
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 On August 12, 2016, FDA issued a revised Draft Guidance on … Continue Reading
“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
Members of the food and dietary supplement industries were among those who responded to a March 9, 2017 request from the U.S. Department of Commerce (DOC) for input on the impact of “Burdensome Federal Regulations and Construction Permitting Process on Domestic Manufacturing.” Comments were due by March 31, 2017. Some of the suggestions from the … Continue Reading
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
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 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
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
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
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
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
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
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
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
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
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
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
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
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 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
New England Journal of Medicine analyzes ER visits in United States linked to dietary supplements. A significant percentage of the U.S. population consumes dietary supplements — a product category that encompasses a wide variety of products such as vitamins, minerals, herbs and botanicals, and amino acids. An article published in the New England Journal of … Continue Reading
