How legislation set up supplements to succeed – and maybe fail

How legislation set up supplements to succeed – and maybe fail

The $32 billion US dietary supplement industry is ripe with opportunity for innovative and healthy-minded formulators and marketers. But given the industry’s breadth and evolving regulatory landscape, the potential for success is often tempered by the kind of business hurdles that could make both industry newcomers and seasoned professionals wake up in a cold sweat.

Over the last 20 years, the U.S. federal government has passed a number of key regulations to which players in the U.S. dietary supplement industry continue to adapt. The following federal regulations were passed in an effort to support greater consumer safety, as well as manufacturing and marketing transparency:

1. In 1994, the Dietary Supplement Health and Education Act (DSHEA) was the seminal piece of legislation that defined dietary supplements as food, not drugs. DSHEA permitted FDA to have oversight on label verbiage, specifically the use of approved structure/function claims that linked ingredients to certain general health benefits.

2. In 2006, the Dietary Supplement and Nonprescription Drug Consumer Protection Act was passed to promote the practice of “adverse event reporting” (AER), enabling the FDA to report dietary supplement-related dangers and warnings to the public, just as they do for FDA-approved drugs and biologics.

3. In 2007, FDA issued Good Manufacturing Practices (GMPs) for dietary supplements. The GMPs detailed the “requirements and expectations by which dietary supplements must be manufactured, prepared, and stored to ensure quality.” The GMPs outlined how manufacturers were expected to guarantee the identity, purity, strength and composition of their dietary supplements. All companies large and small were expected to be in compliance with the dietary supplement GMPs by June 2010.

4. In 2011, the Food Safety Modernization Act (FSMA) was signed into law. FSMA requires FDA to publish a draft guidance of New Dietary Ingredients (NDI), grants FDA greater authority on product recalls and facility inspections, and leverages greater requirements on imported materials.

5. The next avenue of legislation set to influence the dietary supplement industry will likely focus on Genetically Modified Organisms (GMOs). Unlike other countries, the U.S. federal government has no official stance on GMOs to date, and the topic has subsequently become the subject of heated debates, pitting consumers and food safety advocates against politicians and large agriculture/biotech businesses.

In March 2013, President Barack Obama signed the Consolidated and Further Appropriation Act, 2013 into law. Although the primary goal of the Act was providing funding to federal agencies, it included a provision called the Farmer Assurance Provision (dubbed the “Monsanto Protection Act”) that granted a temporary, six-month deregulation status to growers of previously USDA-approved biotech crops and, to the dismay of food-safety advocates, prevented federal courts from halting the sowing, harvesting and sale of the GMO foods despite ongoing legal reviews.

The discord surrounding GMOs has incited many advocacy groups to issue calls for revamped labeling requirements that would make clear to consumers whether or not a product contains ingredients that were genetically modified. That legislative process is still in a grassroots phase.

For the top 10 issues confronting the supplements industry – from regulations to consolidations, bad press to legal concerns – check out the concise, new, 22-page Nutrition Business Journal | Engredea report: “The Fear Report 2013-14: Dietary supplement industry executives’ top 10 concerns, and how to manage them for a better industry.”

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