The issue of “nutraceuticals,” most notably whether they are supplements or drugs and who should regulate them, is hot — really hot. There’s no question, however, as far as the FDA and AAFCO (the American Association of Feed Control Officials) are concerned. Officials say the ingredients are illegal with unproven safety and usefulness, and laws that forbid the sale of nutraceuticals are being blatantly ignored. Indeed, sales continue to skyrocket — almost everywhere that is.
In 1999, Texas cracked down on the sale of certain ingredients in equine supplements (see June 1999) and enforced existing laws that prohibit the sale of products containing ingredients that are not GRAS (generally recognized as safe) or don’t have AAFCO definitions. Other states were also considering similar actions.
Also in 1999, a group of supplement manufacturers questioned the integrity of Corta-Flx, falsely claiming it had undisclosed ingredients and charging that Horse Journal’s recommended joint nutraceutical (see May 1999) did not “adhere to established rules and regulations for the manufacture, labeling and marketing of nutritional supplements.”
As it turned out (see August 1999), the accusing manufacturers also had questionable labels, according to AAFCO guidelines, and Equine America had already rewritten the Corta-Flx label to meet existing standards, replacing the illegal term “chondroitin sulfate” with a generic “animal protein products.”
We worried that label changes like Corta-Flx’s would eventually make deciphering product labels and ingredients even more difficult than it already is.
Indeed, the term “nutraceutical” itself has already been replaced in official circles. AAFCO is calling nutraceuticals “novel ingredients” in order to avoid any therapeutic/prophylactic overtones that may be associated with the original term. (This is because the FDA takes a dim view of any product claiming to have any medicinal benefits without proof, and the term “nutraceutical” was coined as a combination of “nutrition” and “pharmaceutical.”)
We also predicted these manufacturers’ attempts to cause regulatory trouble for their competitor was likely to backfire. Regulatory trouble is definitely afoot — and AAFCO is in charge of sorting it all out for the FDA.
AAFCO established its Nutraceutical Regulatory Framework Advisory Panel (NRAP) to look into the problem and make recommendations. They in turn recommended the formation of two subcommittees, the “Botanicals And Herbs Committee” to look specifically at herbal remedies and the “Novel Ingredients Regulatory Framework Task Force” to look at nutraceuticals with the focus on how to bring these products into line with existing regulations.
The NRAP recommended AAFCO consider a broader definition for the term “nutrient” than its current meaning of referring to only essential nutrients (protein, carbohydrates, fats and National Research Council-listed vitamins and minerals).
The NRAP recommends the definition include “various types of ingested substances that provide natural components of the body and/or offer nutrients that affect the physiological well being of the animal.” This clearly shows a willingness to consider a role for supplements beyond “sustaining life and growth.” However, it’s not going to be quick and easy, and nothing’s changed yet.
John Breitsman, a member of the Novel Ingredients Regulatory Task Force, said companies are breaking the law that now sell products with ingredients that are not GRAS, don’t have feed-additive petitions pending and/or do not have an established AAFCO definition and approved method of analysis. He also said that marketing these illegal/unaccepted products puts the companies under “considerable civil liability” should a consumer believe they had a problem with the supplement and decide to sue.
The other big issue involves claims made for the product by manufacturers. As it stands now, no feed supplement can claim to cure, prevent, mitigate or treat a specific disease. The NRAP suggested they consider allowing “non-drug structure-function” claims. For example, carnitine would be allowed as it functions as a co-factor in the metabolism of fatty acids. However, if a manufacturer took that a step further and said carnitine could stop tying-up by improving energy metabolism that would be a drug claim. It’s a fine line but an important one.
The FDA is clear in what constitutes a drug claim. As Breitsman emphatically concurred, “If used for prophylactic or therapeutic purpose, it’s a drug.” Supplements making such claims on their labeling, advertisements or promotional literature (and there are a lot of them) are technically illegal, as the manufacturers are in fact offering an unapproved drug for sale.
Breitsman believes many companies currently offering illegal products either mistakenly feel there are no laws pertaining to their products or believe they fall under the provisions of the Dietary Supplements Health and Education Act (DSHEA), which does not apply to animal feed (see June 1999).
At the 1999 annual AAFCO meeting, Breitsman proposed AAFCO begin identifying these products and notifying the manufacturers they are in violation of existing laws via an Internet surf day, scheduled for October. Its purpose at this point would be strictly educational.
Breitsman said the FDA and individual states simply don’t have the manpower or funding to mount extensive campaigns to track down and identify every product and company in violation. However, Breitsman feels that if enough notices go out the word will get around quickly and spur companies into becoming compliant voluntarily.
AAFCO member states have been asked to issue press releases regarding the Internet surf day both before and afterward. AAFCO members will receive a list of unacceptable products originating in their states and will be given appropriate form letters to send out. Follow-up to determine compliance is anticipated, and regulatory action will be considered.
It could get sticky, however, when some states are forced to take regulatory action against products they previously licensed. However, Breitsman believes that licensing such products in the first place can occur through an “oversight” and doesn’t change the fact that under existing laws they are not approved. Breitsman further explained that “when licensed, companies agree to be compliant with the law. The burden is on them.”
Ignorance of the law is not a defense, although AAFCO is using it to explain many violations. They believe by educating the manufacturers they will voluntarily bring their products into compliance or remove them from the market.
So the burning issue is how to get these “novel ingredients” into compliance when the framework to accommodate them does not exist.
The first step is to establish GRAS status for the ingredient with the FDA. The ingredient will then need to fit an AAFCO definition and have an accepted method of analysis that can be used to verify purity/levels in the product. New definitions will often be needed.
An example the NRAP used in its report to AAFCO was animal sources of chondroitin. They suggest a definition such as the one used for bone meal may be needed — defining something like bovine trachea (the most commonly used source of chondroitins) — as a source of chondroitin and setting minimum levels of chondroitin that must be present.
They then run into trouble with analytical methods to verify these levels. The Association of Official Analytical Chemists (AOAC), AAFCO’s source for testing guidance, doesn’t list an approved method for chondroitin. The Task Force is looking into using established test meth ods endorsed by other organizations as an alternative.
Another option is for manufacturers to file a federal feed-additive petition, but this requires supporting safety and efficacy/utility data that may not be available and may not be entirely appropriate for their intended use either.
Making supplements “legal” by any available avenue will take time. However, the FDA and state officials seem determined to clean house and restore order to the supplements market quickly.
Fortunately, the novel ingredients committee is working on a procedure for products to be granted “conditional status” until there is time to create a new definition or prepare a feed-additive petition. As long as there are no significant safety concerns, steps will be put in place for companies to petition for this designation and continue to market their products.
The good news is that it’s unlikely all currently illegal ingredients will disappear. There appears to be no need to “stock up” on your favorite supplement. AAFCO appears to be working toward a sane approach to bring companies into compliance with existing laws or develop new pathways for doing so. A generous time frame will allow these companies to search the existing literature for documentation and fill in the gaps with their own studies as needed. This is basically what feed officials are proposing. The Internet surf day is a wake-up call.
Regulation is necessary. Product safety and quality are big issues. It’s going to take a lot of effort and money, but the result should be better, safer — and more effective — products.
Also With This Article
Click here to view “FDA’s Concern: Safety.”
Click here to view “Can Manufacturer Organizations Really Help With Regulations'”
Click here to view “Herbals Status.”
Click here to view “Label Changes Already In Progress.”
Click here to view “AAFCO Requirements.”