At the NIA West conference this week, Mark LeDoux, chairman and CEO of Natural Alternatives International, closed the day's seminars with seven predictions for the supplement industry in the coming year. Mark is one of the few CEOs in the industry who truly understands the business, politics and regulatory landscape of the supplement industry. Because of his broad expertise, I share his predictions below.
7 predictions for 2012
We should expect to see a revised New Dietary Ingredient (NDI) guidance document out by the end of the calendar year of 2012. Engagement between industry and the FDA is absolutely mandatory.
The FDA will step up enforcement of Good Manufacturing Practices (GMPs) and will also continue pressure on label claims and cite unapproved new drug claims in warning letters.
The number of warning letters citing basic flaws in a significant number of inspections will initiate Congressional action.
If Congress gets involved in any significant review or rework of the Dietary Supplements Health & Education Act (DSHEA), life as we know it will abruptly change leading to the real potential of pre-market registration requirements.
FDA and FTC are going to step up collaborative enforcement.
Self policing activities by industry have been ineffective as evidenced by the number of warning letters citing basic deficiencies. Our greatest enemy is complacency.
- The alarming number of warning letters is fertile ground for political posturing, not to mention litigation by an enterprising plaintiff’s bar.
Bill Frankos, formerly of the FDA and now with Herbalife, added: "By the end of the year, supplements will be classified as 'high risk foods' that under the Food Safety Modernization Act will enable the FDA to increase spending on enforcement and potentially recalls."
So, in other words, now is not the time to sit back and relax. Storm clouds are gathering in the regulatory hemisphere, and responsible manufacturers best stay sharp, lest they get caught unaware.
What do you predict will happen in the coming months?