Tag Archives: FDA

The U.S. FDA is moving closer to adopting regulations that will ensure the safety of ingredients that go into all those capsules and tablets consumers ingest in the hope of promoting health and preventing disease. The agency issued draft guidance on August 11, 2016, a revised version of what it had proposed back in 2011. The revised draft presumably takes into account industry comments on the old version, which were scathing, particularly from politicians representing the Supplement Belt. The U.S. FDA is moving closer to adopting regulations that will ensure the safety of ingredients that go into all those capsules and tablets consumers ingest in the hope of promoting health and preventing disease. The agency issued draft guidance on August 11, 2016, a revised version of what it had proposed back in 2011. The revised draft presumably takes into account industry comments on the old version, which were scathing, particularly from politicians representing the Supplement Belt. Not surprising that the revised version has also generated similar reactions. That the industry compliance will cost billions of dollars, which will of course show up in the price the consumer will pay. It may be costly for the industry, but it’s a boon for the consumer. It would be hard to deny that regulatory oversight has been long overdue for all those ingredients, in their natural or modified and altered forms, that go into dietary supplements. The products are currently allowed to be marketed in the U.S. on the basis that as long as they didn’t make any health claims they simply had to be harmless when ingested. What is safe and not safe has generally been based on evidence of established use in food or as food, or sketchy scientific data. It has been generally assumed that naturally occurring substances, whether vitamins,