“Just because we haven’t taken enforcement action people seem to think it [CBD] is OK,” said Steven Tave, director of the FDA’s Office of Dietary Supplement Programs, at a recent industry conference. “Anyone who thinks it is lawful is mistaken.”
Amarin Corporation, maker of EPA drug Vascepa, has sued two omega-3s finished good manufacturers for unfair trade practices for allegedly using the results of the company’s large scale drug trial to market their own fish-oil based dietary supplements.
The Nagoya Protocol, the big changes coming for Lactobacillus classification, and how to boost your chances of success with an NDI notification were just some of the topic covered during the third annual IPA Workshop in DC.
Does DHSEA contain within it the seeds of the industry’s downfall? The freewheeling marketplace this regulation created has placed the barriers to entry so low that less than reputable companies have room to maneuver, creating risk for the whole industry.
Are dietary supplements getting ‘better?’ Or are the new products that come onto the market merely a matter of churn, replacing tired packaging and marketing concepts with updated versions?
A new study has found that supplements marketed for weight loss and sports applications that contain the ingredient higenamine had widely varying and unpredictable dosages of this stimulant.
The confused picture on New Dietary Ingredients became a bit clearer this week when FDA updated the public docket on filings and said it does not expect there to be a significant change in how many companies are choosing to go through the process.
A statement by FDA Commissioner Dr. Scott Gottlieb on the approval of a CBD drug has left some industry stakeholders wondering what the exact implications are for the many CBD products being marketed as dietary supplements.
Algatechnologies has launched Fucovital, a fucoxanthin oleoresin produced and extracted from microalgae, available in the US and Japan with launches in other markets to follow.
Nootropics is an area of the dietary supplement industry burgeoning with new ingredients. But at the ragged fringe of the category are drug-like substances that just won’t go away.
A recent sharp drop in the number of NDI Notifications filed with FDA has industry stakeholders scratching their heads and serves to shine a spotlight on the continuing uncertainty surrounding the present system for bringing new ingredients to market.
The Natural Products Association said that members had more than 200 meetings with members of Congress and their staffs at the organization’s recent advocacy event.
Does CBD belong in dietary supplements? FDA says no, and many industry stakeholders who sounded off at a recent industry meeting were inclined to agree.
Since receiving an NDI for its BQQ Ingredient in 2008, Mitsubishi Gas Chemical America is uncovering further potential benefits beyond cognitive health functions such as increased energy and stamina.
