2012: A year of promise and peril

For centuries, the year 2012 has been anticipated as an ominous one. If the Mayan calendar is correct, you can stop making your 401(k) contributions now. But let us assume the Mayans got it wrong, and we are all going to have to think about what the year 2012 may look like. Here are several issues that should be on everyones think-about" list:

A new era of preventive controls

The Dietary Supplement Health and Education Act of 1994 (DSHEA) is approaching its 20th anniversary, and the key provision (new dietary ingredients [NDIs]) is yet to be fully implemented. Remarkable. In fact, the NDI issue could blossom into a watershed event; one that could redefine our working relationship with FDA, the media and possibly many of our consumers. The central issue here is (and has been for the last 50 years) who controls the decision to launch a new dietary supplement into the market. In many countries (whatever they call dietary supplements), it is the government. In the United States, it is the company, unless FDA believes it is something new. But, we are now back to the question, When is something new or old?" As it stands now, we dont know.

FDA and industry read the same statutory language in DSHEA (Section 413) and arrive at different interpretations. It is this difference of interpretation over about 10 words that created all the excitement in 2011. In the meantime, industry should be laser focused on improving GMP (good manufacturing practice) compliance, analytical testing rigor, supplier qualifications and auditing. There is good reason to believe FDA (and FTC, interestingly) are increasingly skeptical about commitment to quality, safety and product security, as evidenced by frequent GMP failures, particularly over product identity testing.

FDA also believes thousands of NDIs are unfiled, which suggests industry has not gone back to read DSHEA for a while. So, the NDI tool" is, as FDA puts it, the only premarket preventive control with respect to the regulation of dietary supplements." This makes NDI reviews the most effective means to move industry toward greater DSHEA compliance. Views differ on how to resolve the current NDI stalemate, but no one should disagree that high GMP compliance, more vigorous testing, workforce training, third-party certification and vendor audits are our best long-term response to the NDI controversy. DSHEA succeeded because we held the high ground (most of the time). Poor quality is not the high ground. Many eyes are watching how we handle and resolve the NDI provision of DSHEA, and the hard part is only beginning.

London 2012 Olympics

The Olympics are the ultimate temptation for athletes to find an advantage when fractions of a second are the difference between fame and wealth, or being just a statistic in the annals of Olympic history. Sometimes, this advantage has been a cutting-edge chemical, and sometimes, these chemicals are labeled as dietary supplements. Other times, athletes claim victimization and blame the supplement for containing undeclared ingredients. In all cases, the dietary supplement community is damaged. Spiked supplements or undeclared ingredients end up as a mini-referendum on DSHEA, and no matter how many times we point out that such behavior is illegal under a host of laws, we hear the same refrain: It is DSHEAs fault. Again, the most convincing response is to invite the world to look at the quality of our supply chain, our manufacturing processes and our label integrity. Quality is our Kevlar.

U.S. November elections

Finally, the November elections in the United States carry greater industry significance, as Sen. Orrin Hatch (R-Utah) is up for reelection and is facing a strong challenger. The winds of public discontent and anti-incumbent sentiment blow across Utah as they do elsewhere. No election race can be taken for grantednot in 2012. The 20-year cooperation of Senators Hatch and Tom Harkin (D-Iowa, who sit on far ends of the political spectrum) in their unwavering support for consumer access to dietary supplements is truly remarkable and perhaps unique in political history. Those who have been involved in the dietary supplement industry for fewer than 15 years have enjoyed what can be described as the political weather of San Diego. Just ask anyone who has been around for more than 20 years. Strong and committed political leadership in Washington has been a hallmark of the natural health and dietary supplement industries going back to the beginning of food and drug legislation. The work of educating and supporting elected officials is a continuous one. There can be no complacency about this.

As we have seen in the past and will surely see in the future, our business is a uniquely populist one, evoking intense citizen action, government reaction and consumer uprising. This is to be expected, as we are the meeting point of personal liberty, the right to choose personal health as well as personal beliefs. Around the world, we are often admired for this activism, and yet we are also criticized, sometimes rightly so, when we have failed to deliver what consumers want most: trustworthy, safe and reliable natural health products. Respecting their needs and honoring their trust is a high calling and one not to be trifled with.

So, in this new year of great promise and potential peril, plan on being called for duty. There is plenty of work for everyone.

Loren Israelsen is executive director of the United Natural Products Alliance (UNPA), a trade association of dietary supplement companies committed to safety, science and quality. He has been involved in the commercial and regulatory issues facing the global dietary supplement industry since 1980. He has served as vice president/general counsel to the American Herbal Products Association (AHPA), co-founder and counsel to the European American Phytomedicine Coalition (EAPC), industry liaison to FDAs Expert Advisory Committee on Ephedra, industry advisor to the Office of Dietary Supplements (ODS), expert panel member on IFTs Functional Food Report (2005) and most recently sat as an expert panel member to the Department of Defense/RAND study on dietary supplement use among military personnel.