FDA

Can Strange Bedfellows Lead to a Productive Marriage?

<p>Even though FDA imposes authority over the supplement and functional food industry, companies and trade organizations that work with the agency can affect positive regulatory outcomes.</p>

When any industry endeavors to work with the government agency that regulates it, the potential for suspicion and distrust looms. The dietary supplement industry’s relationship with FDA is certainly no exception. Long before the Dietary Supplement Health and Education Act of 1994 (DSHEA), adversarial tensions often arose between the two. In many ways, that level of distrust led to the passage of DSHEA—to assure consumers and industry alike of the boundaries of FDA’s authority over dietary supplements.

Even since 1994, FDA and supplement manufacturers/marketers have sparred on occasion, on issues like ephedra and what constitutes a disease claim, but more often, the interactions between companies (and their trade associations) and FDA are productive ones—tentative sometimes, and certainly wary, but many times producing better results than adversarial encounters would. It’s a lot like a family holiday dinner—the consequences are too great to just walk away, so we have to find ways to work together.

The responsible industry and FDA are aligned on many issues. In 2006, the industry pushed for passage of a law imposing mandatory adverse event reporting for supplements with cooperation from FDA. In 2010, the Council for Responsible Nutrition (CRN) collaborated with FDA to address the problem of products adulterated with prescription drugs masquerading as supplements, leading to increased enforcement against these illegal products.

Sometimes, industry finds it can lead the agency in the direction that best serves both the industry and consumers. For example, DSHEA authorized FDA to develop GMPs (good manufacturing practices) for dietary supplements that fall somewhere between the regulations for conventional foods and drugs. As early as 1995, the industry, led by CRN, submitted a draft proposal to FDA outlining the industry’s recommendations for what GMPs should be, eager to move the agency forward. For 10 years, CRN continued to prompt, cajole and urge the agency to act. When FDA issued the final regulation in 2007, many of the concepts and recommendations advanced by CRN were included—evidence that companies that put reasonable proposals on the table can enjoy a meal they helped to prepare.

Another example of the benefits of working with our regulators is the effort of the SIDI Work Group to articulate standards and guidelines for product identification and vendor qualification. SIDI, a collaboration of three industry groups, developed templates for communication between ingredient suppliers and finished product manufacturers to identify and describe ingredients. Although FDA has not officially sanctioned the Work Group’s completed projects, agency officials were regular participants in development meetings, offering advice and perspective. Should the agency choose to issue guidance for vendor qualifications or acceptable specifications for ingredient identity, one can’t help but think the industry is a step ahead with existing recommendations for best practices that meet FDA’s scrutiny, developed with input from agency personnel.

Of course, the dance between FDA and industry isn’t always so productive, as illustrated by the new dietary ingredient (NDI) draft guidance released in 2011. As with GMPs, DSHEA authorized FDA to implement the NDI provisions of the law, and industry asked FDA for clarification on how it would enforce those requirements. But to many in the industry, the draft guidance produced by FDA seemed more of a revision of the law’s requirements than an explanation of them.

In this case, the industry response was a carefully executed strategy for resolving marital discord, designed to encourage the agency to rethink its positions as CRN submitted detailed, rational comments outlining the concerns with legal and logistical implications, while using political muscle from our Congressional allies, and sounding a grassroots alarm to retailers and consumers. The subsequent series of meetings between industry and FDA on NDIs suggests that a dialogue with the agency trumps hostility for helping FDA understand industry’s perspective.

Increasing FDA’s resources is also in responsible industry’s best interest so the agency can do its job more effectively. Too often, fly-by-night companies that make outlandish claims or market illegal products dominate media attention and wrongly come to represent the whole industry. In these cases, it’s of value to responsible industry for FDA to have the enforcement resources to stop these criminals. Industry must encourage Congress to appropriate sufficient resources to FDA. To some, that might seem like strange bedfellows—an industry lobbying for funding so that its enforcers can engage in more enforcement. But that’s exactly what we need. And as priorities at the agency are stretched by the latest food contamination incidents, it’s critical that the supplement division of FDA has resources to do its job as well.

If the relationship between industry and FDA sounds like an arranged marriage or a shotgun wedding, it’s because it is. But in the case of FDA and the supplement industry, we’ve got to make it work. A focus on the common purpose to better serve consumers with quality products that improve health is in everyone’s best interests. By working together, we can reassure our customers, and even our detractors, that a mature industry accepts a certain amount of oversight needed to help the cream of the industry rise to the top and to force the bottom dwellers out. Our industry and FDA are learning to work together, so that when our consumers ask themselves if they trust the dietary supplements they take for better health, they can resolutely respond, “I do."

For more information on laws that regulate the industry, visit INSIDER’s Regulatory Content Library.

Steve Mister is president and CEO for the Council for Responsible Nutrition (CRN), a dietary supplement industry trade association.

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