For The Consumer, The Prospect For Safer Dietary Supplements

For The Consumer, The Prospect For Safer Dietary Supplements

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 The agency issued draft guidance on August 11, 2016, a revised version of what it had proposed back in 2011.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 The agency issued draft guidance on August 11, 2016, a revised version of what it had proposed back in 2011.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, minerals or amino acid or traditionally used herbs, must be safe because they were “natural.”

This cut the mustard with the FDA. There was no need to prove that a chemically altered or modified natural substance or a high dose of a natural substance or a combination of several of them in a single product posed any health risk, let alone whether they actually did any good for our health. The era of putting anything natural into a pill and branding it as a supplement will end soon. The agency, under its newest guidelines, has created a classification called New Dietary Ingredient (NDI) and any dietary ingredient that was not marketed in the U.S. before October 15, 1994 will fall into this category. The manufacturer or distributor marketing a dietary supplement with NDI will be required to submit to FDA premarket safety notification at least 75 days before selling the product.

The notification will have to prove safety with scientific data, especially if the natural ingredients have been modified or altered in any way, whether during their extraction or in the process of manufacture of the final product. Evidence of historical use alone will not be enough to claim product safety. This will drastically impact the $30-billion industry, which is mostly made up of companies that thrive on marketing prowess than research and development. There has been little barrier to entry in this industry. In 2012, there were 55,600 dietary supplements in the market, according to the FDA, and since then 5,560 new dietary supplement products have come on the market each year. In 1994, there were just 4,000 products in the market. As much as we hate regulations, FDA’s new regulatory fram.