Supplements Head Down Approval Path

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The furor of protests early in the year over the possible banning of nutraceuticals and herbal supplements for animals is paying off (see March 2002). While it’s far from over, manufacturers and lawmakers appear to be headed toward ensuring both our rights to these products and our animals’ safety in consuming them.

AAFCO (American Association of Feed Control Officials) postponed strongly recommending across-the-board enforcement actions at its spring meeting because of a combination of insufficient FDA input in selecting a target ingredient and the huge response from owners and veterinarians. Even the American Veterinary Medicine Association (AVMA) sent a letter to AAFCO that stressed the importance of glucosamine in the management of arthritis and urged AAFCO to leave decisions regarding the fate of this ingredient up to the individual states.

AAFCO claimed it never intended to remove all products from the market, only to make an example of a particular ingredient to motivate manufacturers to get all “illegal” ingredients officially approved.

No matter how you look at it, however, the bottom line is there is no existing framework for nutraceuticals as a food ingredient. The only approval pathway available was — and still is — as a drug, unless an amendment to the Dietary Supplement Health Education Act (DSHEA) can be passed.

NASC Efforts
Faced with the prospect of impending regulatory action, manufacturers are definitely mobilized.

The nonprofit National Animal Supplement Council is a coalition with members from both the pet and equine food/supplement industries whose major focus is on interaction with AAFCO and the FDA. The NASC released a policy statement called “Compliance Plus,” which is a system for reporting reactions to products and requires NASC members to implement labeling, manufacturing and quality-control standards.

Members would pay dues and contribute a percentage of sales to subsidize research into submitting ingredient definitions to AAFCO/FDA for glucosamine, chondroitin, MSM, garlic and rehmania (an herb). If solid definitions could be written for these products, AAFCO/FDA could consider moving the ingredients to “approved” status.

On July 30, just days before the AAFCO August annual meeting, the NASC submitted an Ingredients Definition Petition to AAFCO/FDA that seeks approval for glucosamine as an ingredient in pet/equine supplements and feeds. NASC hopes to either get a new definition category approved (amino sugars) or have glucosamine declared as a GRAS (generally recognized as safe) substance.

John Breitsman of AAFCO said the petition was well prepared, but the FDA makes the decision, which could take 18 months. Meanwhile, glucosamine will remain an unapproved ingredient and still be subject to any state or FDA regulatory action.

Still, the NASC’s efforts don’t address changing current laws to get approval for inclusion of these ingredients in feeds or supplements, especially herbals. Many herbal companies/manufacturers are concerned that there’s no room for herbs to be classified as anything but a drug without a law change.

CASA’s Work
On the other hand, CASA, or the Companion Animal Supplements Act, does focus on making these ingredients “legal.” CASA, in essence, would be an amendment to the existing DSHEA, which considers herbals and nutraceuticals a separate category from drugs or the basic essential minerals and vitamins, protecting human rights to these products.

Efforts to introduce CASA are being spearheaded by the CASA Coalition, which is a separate outgrowth of NASC’s early investigations into exploring legislative avenues for the supplements problem. The CASA Coalition, now a separate organization, endorses improvements in many of the same areas highlighted by the NASC’s Compliance Plus but concentrates on actual law changes.

The CASA Coalition has made progress. A simple legislation has been drafted to get companion animals, including horses, covered under the provisions of the existing DSHEA. Coalition representatives have met with lobbyists and representatives in Washington, and prominent senators Orrin Hatch of Utah, who was also a supporter of DSHEA and doesn’t shrink from difficult medical-ethical issues, and Tom Harkin of Iowa, chairman of the Senate Committee on Agriculture, both expressed interest in the bill.

Like all things political, it’s going to take time. An amendment to DSHEA will likely require a strong grassroots wave of support, which means animal owners. CASA Coalition representative Thane Stallings said they’re working to form a strong network of concerned owners and professionals, with links to publications, manufacturers and retailers, to alert them to developments and tell them when the time is right to contact legislators and request support of CASA.

Look Out, Comfrey
At their August meeting, AAFCO announced that the Enforcement Strategy for Marketed Ingredients (ESMI) would move forward as planned. While acknowledging the efforts of the NASC as a “good first step,” they didn’t sway from their original intent of targeting an unapproved ingredient for regulatory action. The ingredient chosen was the herbal comfrey, which we believe was wise.

In 2001, the FDA issued a strong letter to human-supplement manufacturers that urged them to stop production of oral and topical supplements that contained comfrey. Comfrey has been banned by Germany and Canada due to concerns over liver toxicity.

While comfrey supporters argue that even suspected cases of adverse reaction are rare, the active ingredients in comfrey have been shown experimentally to be capable of causing liver damage. Comfrey is most commonly found as an ingredient in equine herbal blends directed toward joint, lung or intestinal function.

AAFCO’s move doesn’t mean that all supplements containing comfrey will disappear overnight. AAFCO itself has no real power; its function is as an advisor. It’s remains up to the member states to decide if they want to take action.

Bottom Line
AAFCO’s choice of comfrey as the ESMI-targeted ingredient was met with relief. Many worried it would be glucosamine. However, this doesn’t mean we can relax. At any time any state could ban the sale of any unapproved ingredient.

We’re pleased the NASC chose glucosamine as its first Ingredients Definition Petition product and applaud their work. But these issues are peripheral to the problem at hand. They can’t change the legal status of threatened ingredients.

We believe including companion animal supplements under its provisions is the best option. AAFCO has started the ESMI, and we need to take action to get a law passed. You can join the CASA Coalition (www.casacoalition.org), which will keep you abreast of developments.

You can also let your state’s AAFCO representative (www.aafco.org) and state lawmakers know that you value your supplements and are against attempts to ban their sale in your state. While they really can’t do much until a bill to extend the DSHEA to animals is actually introduced, it’s wise to bring their attention to it now, so that when the issue is finally raised it will ring some bells.

Also With This Article
Click here to view ”It’s Not Just Horse Supplements.”
Click here to view ”Some States Take Action.”