Science is critical, says industry veteran
industry faces in the coming year? Jess Halliday spoke to
Terry Lemerond, founder and president of EuroPharma, about the
pressing need to back up dietary supplements with science.
For over 11 years the dietary supplements industry has been awaiting the final good manufacturing guidelines (GMPs) which form part of the 1994 Dietary Supplements Health and Education Act (DSHEA).
At last there are indications that these are just around the corner. But although they are certainly a step in the right direction that every responsible manufacturer will embrace, Lemerond believes that more needs to be done in the way of scientific evidence-gathering. Companies should be policing themselves, he said.
While there is no need to change DSHEA, Lemerond mused that some kind of product registration scheme may be helpful. But he added: "We don't need to go as far as regulations for drugs in testing every completed product, as the ingredients in supplements are foods."
Under DSHEA only new dietary ingredients not sold in the US before October 15, 1994 need to be approved before they can be used in a product.
Lemerond said that DSHEA does a good job in protecting the consumer's right to buy products - and the alternative flagged at the time the act was passed would have totally destroyed the industry.
But when it comes to the FDA and FTC requirements for products with an indication, "we need to have enough evidence to back them up".
He turned to the joint health category to illustrate this need - familiar territory for the man who takes credit for introducing glucosamine to the US market and who, this year, launched Litozin, "the next generation in joint care".
Since Cox-II inhibitor Vioxx was withdrawn there has been a rush of products to the market, some of which have a paucity of evidence behind them.
Lemerond said that ginger, curcumin and boswellia extract have a history of safe use and are not creating a risk for consumers, but no studies have been done to determine safe and effective doses.
"Why not spend a reasonable amount of money discovering what all the side effects are and showing effectiveness?" he suggested.
If the right dose were established, these products could prove very useful.
"There are a lot of products on the market, and we don't even know whether they enter the blood stream," he said. "A petri-dish is not the same as the human body."
This year, three-year-old EuroPharma announced that it is outsourcing its marketing to Blue Spring Wellness, so it can instead focus on research and development.
The move was predicated in part by an approach from Swiss research institute VitaPlant, with which EuroPharma partnered to develop six new plant extracts.
Lemerond said that the first two of these, which have been researched for their anti-depression and mood enhancing, and anti-stress and adaptogen effects, will launch in the next quarter. EuroPharma is partly funding the research and holds the US rights to the resulting products.
The other products have gone back into development, said Lemerond, since more evidence has been discovered in their favor.
Lemerond said that it is better by far to put out five good products with sound science behind them, rather than 25 not-so-good ones.
"If they have great ideas, companies should put money behind them - or find someone else who can."
The problem is, he said, that there is a rise in 'me too' companies that are putting out products simply because their competitors are.
"All companies should embark on a certain amount of research. We are ready to do that for them."
EuroPharma's business model is built around funding research in exchange for sales-related royalties once the product launches.
It presently has nine products in development, all of which Lemerond is confident will make it to market.
However he admits that there is an element of risk. "Not every egg you crack is going to be a good egg, but every failure is a step forwards," he said.
The research is carried out in Europe, where regulatory standards are stricter. Even so, Lemerond said that Europe is still fertile for innovation.
"We hope 2006 will be a great year, and we hope that more companies will realize the critical issue of science."
