- By: Staff Editor
- Date: November 24, 2015
- Source: ComplianceOnline
What’s Safe in Your Medicine Cabinet: Dietary Supplements in the U.S.
From regulating hormone levels to supplementing nutritional deficiencies in children, dietary supplements have a broad spectrum of needs to cater to. Popping a vitamin pill or biting down on an energy bar is not as simple as it once was though. The plethora of products available to supplement your diet are so staggering that regulating what reaches the consumer has been a challenge of equal proportions.
When the FDA first decided it was time to regulate dietary supplements in the early 90s, the agency drew a lot more flak than it could have anticipated. The flak came from trade associations of dietary supplement manufacturers and consumers. The industry has since witnessed a booming growth, resulting today in the need for FDA to step in with guidance and oversight for its labeling, marketing, and post-marketing as well.
The Dietary Supplements Health and Education Act
The Dietary Supplements Health and Education Act, DSHEA, was signed into law in 1994. The Act defines dietary supplements as, “a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients.”
Dietary supplements marketed in the U.S. prior to the passing of the Act are deemed to have a history of safe use, thereby shifting the focus on products marketed in the U.S. from 1994.
What’s the Drawback?
Federal law does not require dietary supplement manufacturers to seek approvals before production nor before marketing the products. Product advertising too comes under the jurisdiction of the Federal Trade Commission. The products have to reach the marketplace before they fall within the FDA’s perimeter.
In all, both the FDA intervention as well as DSHEA are widely criticized as a failing system that have left the reins with supplement manufacturers. For instance, DSHEA does not set limit levels for vitamins and minerals that can be incorporated in a pill. Meanwhile FDA too has but a limited capacity to monitor adverse reactions from these supplements.
The Verdict
Labels. Although not your safest bet - there are still ambiguities here as well - it’s still the first place to look. The FDA has mandated five elements to be present in dietary supplement labels: statement of identity - name of the dietary supplement; net quantity of contents statement - amount of the dietary supplement; nutrition labeling; ingredient list; and the name and place of business of the manufacturer, packer, or distributor.
The Supplement Facts panel in labels carry essential information on active ingredients and fillers, binders and other added ingredients. Not to be left out, the obscurities lurking behind these labels have come under the scanner too. As a result, in June 2010, the FDA issued cGMPs for labeling dietary supplements among other GMPs for the dietary supplement industry.
How Can Consumers Stay Safe?
The dietary supplements industry stands strong as a $23.7 billion industry in the United States. Despite fluctuating figures over the past few years, the consumption of dietary supplements hasn’t yet taken a steep plunge. What follows in the regulatory world then, in terms of safe guarding consumers, is to increase awareness about the agency’s efforts in identifying manufacturers with product or labeling defects. The FDA Safety Alerts and Recalls page, for instance, carries information that will help keep you posted.
Sources, you’ll soon realize, are not to be taken lightly when it comes to information on consumer products like dietary supplements. In fact, you can even take matters into your hand. Should you seek to report adverse effects from a dietary supplement, here’s where you can do it.
Stay informed, stay safe.
The Other Side of the Coin – Best Practices Training for Marketing Dietary Supplements in the U.S.
