by Loren Israelsen
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 everyone’s “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 don’t 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.
