kratom
Florida Attorney General Files Emergency Rule on 7-OH Products
On Aug. 13, Florida Attorney General James Uthmeier filed an emergency rule to classify isolated and/or concentrated 7-hydroxymitragynine (7-OH) products as a Schedule I controlled substance in Florida. The rule takes effect immediately and makes it illegal to sell, possess or distribute any isolated form of 7-OH in the state. The announcement comes a ...
FDA Takes Steps to Restrict 7-OH Opioid Products
On July 29, the U.S. Food and Drug Administration (FDA) took “bold steps” to protect American consumers from dangerous illegal opioids. The agency recommended a scheduling action to control certain 7-hydroxymitragyine (7-OH) products under the Controlled Substances Act. According to FDA, 7-OH is increasingly recognized for numerous health and safety issues because of its ability ...
FDA Issues Warning Letters on Products Containing 7-OH
On July 15, the U.S. Food and Drug Administration (FDA) announced it sent seven warning letters to companies for “illegally marketing” products containing 7-hydroxymitragynine (7-OH). According to FDA, there is growing concern around “novel potent opioid products” that are being marketed and sold online and in smoke shops, gas stations and corner stores. 7-OH is ...
Panel Covers Current Legal Landscape of Health and Nutrition Industry at SupplySide West
Legal Panel (from left to right): Steve Shapiro, Megan Olsen, Eric Unis, Rend Al-Mondhiry, Robert Durkin and Rick Collins. From CBD to kratom to notification letters and more, a panel of legal experts held a discussion on what they deemed as the most pressing topics in today’s complex regulatory environment in the natural products industry. ...
Kratom Association Releases Consumer Advisory on FDA’s Failure to Regulate Kratom Products
On July 31, the American Kratom Association (AKA) issued a Consumer Advisory on the U.S. Food and Drug Administration’s (FDA) failure to properly regulate kratom products. “The American Kratom Association urges the FDA to immediately publish product manufacturing standards for kratom products that are sold to consumers and encourages the removal of kratom products that ...
NPA Asks FDA to Stop Fraudulent Products from Entering U.S.
The Natural Products Association (NPA) urged the Food and Drug Administration (FDA) to do more to stop fraudulent products from entering the U.S., including issuing import alerts for nutritional supplements that fail to comply with New Dietary Ingredient (NDI) regulations. NPA submitted its comments to the FDA regarding “Food Standards; General Principles and Food Standards Modernization.” ...
NPA Calls for FDA Action on Imported Adulterated Dietary Supplement Ingredients
The Natural Products Association (NPA) urged the U.S. Food and Drug Administration (FDA) to issue import alerts for nutritional supplements that fail to comply with New Dietary Ingredient (NDI) regulations. NPA submitted comments for the record to the Senate Finance Committee’s hearing “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process.” The hearing will take ...
ABC Comments on Kratom
On December 1, the American Botanical Council filed comments in response to the U.S. Drug Enforcement Administration (DEA) Solicitation of Comments regarding the scheduling of two compounds in the kratom (Mitragyna speciosa) plant into Schedule I of the Controlled Substances Act (CSA). ABC set forth to the DEA in its comments that emerging science supports ...
DEA Postpones Ban on Kratom
On August 31, 2016, the Drug Enforcement Administration (DEA) published in the Federal Register a notice of intent to temporarily place mitragynine and 7-hydroxymitragynine, which are the main psychoactive constituents of the plant Mitragyna speciosa, also referred to as kratom, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. Since ...
DEA Kratom Change “Toothless” Without Government Enforcement, Says NPA
The Natural Products Association (NPA) recently responded to the United States Drug Enforcement Agency’s (DEA) decision to add kratom and mitragynine to its list of schedule I drugs. Dan Fabricant, Ph.D., CEO and executive director of NPA, said, “Kratom has been a public health target for almost five years, and its surging growth in use ...
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