Nutraceutical maker calls
for industry standards
standards for production, performance
BALTIMORE — A leading maker of veterinary nutraceuticals has called on its own industry to develop standards it says are needed to protect veterinarians, pet owners and patients and to foster appropriate use of true nutraceutical products.
At a press conference held during the annual meeting of the American Veterinary Medical Association, Dr. Robert W. Henderson, president of Nutramax Laboratories, Inc., Baltimore, proposed the development of standards to clearly define the term “nutraceutical.” Standards also would help resolve some of the problems created by the current regulatory situation, he said.
There are no laws specifically governing the manufacture and sale of veterinary nutraceuticals.
“But if a veterinary nutraceutical manufacturer makes even the slightest therapeutic claim about a product, that product is automatically recognized as a drug and becomes subject to FDA review,” Henderson explained.
“We understand and support the need for regulation. But at the same time, we feel strongly that laws made to regulate FDA-approved ‘drugs’ are not always applicable to true nutraceuticals, which are non-toxic, natural substances.”
Hinders information exchange
Keeping veterinarians abreast of new findings about nutraceuticals is difficult to impossible under current regulations. “Even if independent data demonstrate that a nutraceutical has some clinical benefit, the manufacturer cannot relay that information to the veterinary community,” he added. “As a result, there’s no opportunity for a meaningful exchange of scientific information and observations in this emerging industry — and we see that as a setback for veterinary medicine.
“I presently know of numerous board-certified veterinary orthopedists who are now recommending our product Cosequin — and this is just one type of nutraceutical product,” he added. “This indicates that there are veterinary practitioners who already believe these compounds have merit and who are interested in learning more about nutraceuticals.”
Henderson thinks that, in some ways, current restraints on communicating information about nutraceuticals have done more to confuse veterinarians about nutraceuticals than to protect them from misinformation.
“The regulatory situation that prevents responsible manufacturers from disseminating information also makes it difficult for veterinarians and pet owners to distinguish true, beneficial nutraceuticals supported by science from bogus ‘miracle’ products,” Henderson said.
This situation is also hindering wider acceptance and use of true nutraceuticals. The only way to solve this predicament is for the industry to develop its own standards and eventually have them accepted by FDA,” he said.
The time is ripe for development of standards because the nutraceutical industry is growing fast, Dr. Henderson said.
Proposes review board
Henderson said that nutraceutical standards should be developed by an industry-sponsored national review board and could be used to certify true nutraceutical products. Ideally, the review board would be comprised of veterinarians, including those board-certified in appropriate specialties and general practitioners, as well as veterinary pharmacists.
“We also would like to see involvement from the FDA’s Center for Veterinary Medicine,” he said.
The standards would have to first define a true nutraceutical. True nutraceuticals, according to Henderson, are not drugs. They are products that contain natural substances recognized by the body; they also have a wide margin of safety and measurable clinical effects.”
Henderson believes the term “nutraceutical” should be limited to nutritional products used in a familiar medical form, such as capsules, tablets, powders and liquids. “In the human market, some people are using the term nutraceutical to describe everything from broccoli to high-fiber cookies,” he added. “I think that’s taking it too far.”
The standards for certification should also require quality manufacturing practices, as well as scientific data justifying the use of a product and data demonstrating its safety, he said.
“Ultimately, we would like to see the manufacturers of certified nutraceuticals allowed to make reasonable and responsible claims about their products,” Henderson said. “Otherwise, we are forced to keep veterinary practitioners in the dark about the clinical value of nutraceutical products. Certification also would give veterinarians and consumers a way to evaluate nutraceuticals, while fostering responsible practices within the nutraceutical industry.”
Independent support voiced
Support for the development of standards also came from Dr. Dawn Boothe, an assistant professor of veterinary physiology and pharmacology and director of the clinical pharmacology laboratory, Texas Veterinary Medical Center, College of Veterinary Medicine, Texas A & M University, College Station.
“For veterinary practitioners, knowledge and discriminatory power are the most obvious benefits to be gained by the establishment of nutraceutical standards,” she said.
“Industry standards would help them determine which nutraceuticals truly provide a therapeutic benefit and which do not,” Boothe added. “Most important, we should not forget that the recipient to be benefited most by standards is the pet suffering from the target disease.”
The ability to demonstrate characteristics of a nutraceutical product, such as batch uniformity and bioavailability, will be essential to the development of standards, which can only serve to protect veterinarians, consumers and animals,” she explained. “Standards also will help ensure the credibility of ethical nutraceutical manufacturers.”
Setting an example
Henderson said that in addition to its call for standards, the company plans to lead the way by setting an example. Nutramax Laboratories is presently building a new production facility that is expected to meet the same GMP (good manufacturing practices) standards used for making FDA-approved pharmaceuticals — even though there are no laws requiring the company to do so.
In closing, Dr. Henderson called on other responsible nutraceutical manufacturers, veterinary researchers and pharmacologists to join Nutramax in its effort to develop standards that will protect veterinarians and other consumers.