Austin, TX—Applied Food Sciences (AFS) has presented the GRAS dossier for its AMATEA organic guayusa extract to FDA for review, according to a press release, and has received a “no further comment” response. AFS partnered with AIBMR Life Sciences to compile their dossier. The “no further comment” response indicates that...
Washington, D.C.—The Natural Products Association (NPA) has urged FDA to issue import alerts for supplements that fail to comply with NDI regulations, according to a press release. 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...
Washington, D.C.—Three trade associations representing the dietary supplements industry have sent a proposed framework for an NDI master file to Steven Tave, the Director of the Office of Dietary Supplement Programs. The goal with the proposed framework is to address the protection of innovation, according to the letter, which was...
Biota Biosciences is voluntarily recalling several lots of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables to the customer level, according to a statement from the company. These injectable products are being recalled because they were marketed without FDA approval. The statement adds: “The products claims on our...
Washington, D.C.—Texas has proposed new rules for hemp and cannabidiol (CBD) products, according to a press release from the Natural Products Association (NPA). The proposal released by the Texas Department of State Health Services is intended to create rules related to: The manufacturing, processing, and distribution of consumable hemp products;...
Silver Spring, MD—The FDA and FTC issued warning letters to two companies for selling fraudulent COVID-19 products. The companies were Honey Colony LLC and Dr. Dhole’s Sushanti Homeopathic Clinic. Honey Colony offered products including Quicksilver Liposomal Vitamin C, Jigsaw Magnesium with SRT, and Silver Excelsior Serum for sale in the...
Silver Spring, MD—FDA and FTC have issued three warning letters to companies selling fraudulent COVID-19 products. The companies warned: Savvy Holistic Health dba Holistic Healthy Pet sells fraudulent products with misleading claims about the prevention or treatment of COVID-19 in people and pets. The products include “China Oral Nosode” and...
Washington, D.C.—The dietary supplement industry is commending FDA for taking action to protect consumers by calling out marketers who make illegal and unsubstantiated drug claims related to COVID-19, according to a press release. FDA has sent 16 warning letters to companies claiming that their products can prevent, treat, or cure...
Washington, D.C.—The Food and Drug Administration (FDA) announced that the FDA and Federal Trade Commission (FTC) issued warning letters to three companies for selling fraudulent COVID-19 products. The letters went to Gaia’s Whole Healing Essentials LLC, Homeomart Indibuy, and Health Mastery Systems DBA Pure Plant Essentials. Gaia’s Whole Healing Essentials...
Washington, D.C.—The Food and Drug Administration (FDA) announced that it is providing temporary flexibility regarding nutrition labeling of certain packaged foods in an effort to better facilitate the distribution of food during the COVID-19 crisis. Information can be found here: Guidance for Industry: Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food...
