This was a tumultuous but educational year for the industry. Many companies spent a lot of time and money in an effort to keep up with the new GMP regulations and the still-young adverse event reporting (AER) law. At the same time, companies kept a watchful eye on FDA and FTC actions, particularly with regard to substantiation. Is it true companies will need two good double-blind, randomized trials to substantiate claims in the future? And will EFSA ruin the promise and potential of functional foods in Europe? Only time will tell, but our experts have many theories and predictions about these issues.
In terms of growth, market research continues to indicate that consumers are relying more and more on the use of dietary supplements and functional foods to keep healthy, especially in instances where mainstream healthcare has failed them. As we enter the depths of the cold and flu season, I’m sure consumers will flock to these categories with greater frequency. The key here is to make sure they remain happy and, most important, healthy.
So what did the industry learn this year? Hopefully it learned that FDA is taking facility inspections very seriously. And based on those already conducted, industry should be learning some lessons about what FDA is looking for—especially in terms of facility cleanliness, record keeping and testing protocols.
Next year will be a pivotal one for dietary supplements and functional foods. In an environment of increased enforcement—in all areas of business—companies must rise to the occasion in order to navigate the bumpy roads ahead. The future depends on it.
