Regulatory fervor in the dietary supplements industry seems to wax and wane with the political tides. Right now it's approaching a fever pitch. Here's a look at a couple of areas of particular concern.
New Dietary Ingredients
The old Boy Scout motto — be prepared — applies now more than ever.
It is expected — though it's not certain — that FDA will issue a guidance document covering the issue of New Dietary Ingredients (NDIs) sometime in 2011. No one can know for sure what this document will say, but experts familiar with the issue are unanimous in saying companies had better start getting ready for the worst.
The cloud that hangs over the industry is this: If FDA takes a broad view of what constitutes an NDI and therefore creates a large number of ingredients that might be subject to an NDI filing, it could create a huge backlog of such filings at the agency. It's possible that for a significant number of ingredients and finished products, companies might have to choose between being in technical violation of the law by continuing to sell an ingredient, or pulling a product from the shelves while awaiting the very uncertain outcome of an NDI filing.
When DSHEA was passed in 1993, the bill's language was vague as to the definition of what constitutes an NDI. The statue includes a "grandfather" date of Oct. 15, 1994. Any ingredient that came on the market after that date was supposed to have gone through the NDI filing process.
"We know form the 'podium policy' over the last couple of years that there are people who would cast it very broadly, as to what's an NDI," said Steve Mister, president and CEO of the Council for Responsible Nutrition. "There are a few things that are clearly grandfathered. Then there are some things that are clearly new. Then there's this huge gray area."
"There are a lot of things they have done that clearly telegraph that. When you get bits and pieces of what FDA is thinking they are going to define it as broadly as possible in their favor," said Todd Harrison, an attorney with law firm Venable LLP.
Another issue centers on how you determine what was on the market in 1994. "There is no single official list of what was on the market in 1994," Mister said.
FDA never generated its own list of these ingredients at the time, nor did it accept any list submitted by industry.
And, while FDA sat on its hands the world changed. Records went from paper and microfiche to floppy disks and then online, with an inevitable data losses along the way. So proving what was being sold in early October 1994 becomes harder and harder.
So what can companies do to prepare for this very uncertain future?
"I think I would want to be really thinking about what am I doing that was really different than 1994," Mister said. "What's my evidence of safety?"
At the end of June this year the final stage of FDA's program of enforcing Good Manufacturing Practices went into effect. Now all companies, including the third tier of smallest companies, are required to be in compliance.
According to Loren Isrealsen, executive director of the United Natural Products Alliance, there have been 90 inspections to date. A number of 483s (a list of problems to be fixed) have been issued, and two warning letters have been issued as a result of GMP inspection findings.
Some trends have emerged from inspections so far. Raw-materials testing is becoming a big issue. The regulations are somewhat vague as to exactly what tests are supposed to be done, leaving it to the company to come up with a "scientifically valid" method.
In Israelsen's view, identity testing remains a weak point and could become the focus of future regulatory action.
Also up for review is the competence of various GMP consultants. "My sense is there are too few competent and qualified GMP consultants/advisors," Israelsen said.
And the reliability of contract labs offering testing services is another area of risk. There are a number of well-known and respected players in the field, but also a number of less-well established operators.
Both are areas in which industry could serve itself well by being proactive by coming together to define a way in which the competence and qualifications of these consultants and labs could be vetted.
The game-changer: New Dietary Ingredient regulations
Some companies whose ingredients seem to meet the grandfather clause might be inclined to breathe a sigh of relief at this point.
Not so fast. What if, for instance, your botanical is now extracted with water, whereas alcohol was being used in the early '90s for the same extract? Or what if you found a way to boost the extract concentration into the 90 percent range, whereas the grandfathered material came it at 60 percent? Or what if you have changed your process to somehow boost the ingredient's bioavailability? All of these cases could end up being defined as NDIs under the new guidance.