Editorial: Is Failure Looming for Natural Health Products Regulations?

By Len Monheit
[email protected]

The dialogue is heating up in New Zealand over the proposal for New Zealand and Australia to co-regulate natural health products including dietary supplements. The New Zealand government has announced that it intends to sign the treaty next week, despite the fact that an information gathering committee formed eight months ago has not yet tabled its report. This essentially means that industry and consumer feedback, and the money spent in this information gathering process, will come to naught.

Many involved in this trans-Tasman harmonization process, especially those in New Zealand, view this development as the culmination of what is clearly a non-consultative process. New Zealand’s government had essentially ‘done the deal’ back in November of last year when it declared its intent to go ahead with joint regulation. Minister of Health Annette King attributes current urgency to finalize the treaty to the Pan Pharmaceuticals ‘situation’ where an improperly produced OTC product was the catalyst for revoking that company’s manufacturing license and pulling from shelves thousands of products in several countries, including New Zealand. This recall affected drugs, OTC products and supplements, yet the brunt of the negative press surrounded the potential vulnerability of what has come to be commonly described as the‘largely unregulated dietary supplements sector.’

This issue raises a couple of significant points for those involved in regulatory dialogue around the world. First of all, the major trigger point is obviously product safety - and it’s a very effective and empowering trigger. Secondly, despite democratic process and words which suggest a collaborative (or at least co-operative) approach exists, several feedback mechanisms did not or are not working in New Zealand.

Interestingly, the Pan ‘situation’ occurred in an environment where the governing agency, the Therapeutic Goods Association (TGA) was regulating natural health products as therapeutic products, and not as foods. Obviously, the existence of enforceable regulations was not the fundamental issue. If enforcement capability (resources, agency will, alternative agendas, and any number of related factors) is the real issue, it’s a scary situation for both industry and regulating agencies with parallels in both Canada and the US.

In Canada, new regulations are in effect beginning January 1, 2004, the end product of a three year collaborative process between government, industry and consumer stakeholders. Although there has frequently been vocal opposition, the intent and commitment to collaboration has been quite evident on the part of Health Canada-Natural Health Products Directorate. The new regulations officially creates a middle ground between drugs and food for natural health products and the new directorate is staffing up in anticipation of significant resource demands. At the same time, it has admitted it doesn’t really know just what the burden is going to be in product and site licensing applications it will need to process. Site inspections will continue to be managed by The Health Products and Food Branch Inspectorate (HPFBI), although this branch will use a Policy document created specifically for Natural Health Products. This has given rise to a fear on the part of industry that a drug standard will apply, since the inspectors are more familiar with drug regulations, interpretations and policies.

The challenges looming for the Natural Health Products Directorate are inevitably going to be resources and enforcement philosophy. And with the issue of user fees looming at some point in the future, cost implications of the entire process will become a factor.

The treatment of dietary supplements in the US is quite similar to New Zealand, as food rather than drug. The very safety concerns that generated such urgency on the part of New Zealand’s government are being expressed with regularity on Capitol Hill and in the media. The resource and enforcement issues that appear to be to blame for the Pan quality assurance breakdown, are mirrored in the US, where FDA has admitted it needs more resources and funding and this funding has been proposed. Lack of resources, as it appears to have done in the Pan ‘situation’, may critically undermine all efforts to implement and enforce GMP’s. Perhaps even more importantly, this resource lack prevents outliers who make outrageous claims from being aggressively forced out of business or punished to discourage further illegal activities, a sad situation which harms the entire industry.

Safety is the major trigger – as it should be. And with Joseph Levitt retiring from his position as Director of FDA’s Center for Food Safety and Applied Nutrition, a period at FDA is continuing where food safety and security decisions will justify many government and agency actions. Levitt’s replacement, Dr. Brackett, has been in charge of food safety and security at CFSAN, including food safety policy issues and new food safety programs. It is clear that this changing environment will have consequences for the dietary supplements industry, with the first chapter being the present facility registration process and prior notice requirements under the Bioterror Act.

Despite reasonable intentions, legislative mandates and attempted collaborative approaches, in each of these regions, a potential failure is looming. In each case, industry is vulnerable to circumstances that have either always been beyond its control or which have passed out of that control. Whether we’re dealing with foods or dietary supplements, processes such as GRAS affirmation, toxicology studies, adverse event recording and strengthening a perception of an industry composed of safe, responsible companies voluntarily taking a high ground are imperative and worthwhile investments. As far as the regulatory agencies are concerned, industry must continuously express both its will to collaborate and its intent to comply – to the agencies themselves and to the population at large.

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