The uncertain future of herbal product regulation

At the time this is written, many questions on the regulation of herbal products in the United States and Canada still remain. Both jurisdictions are going through an important transition phase that will greatly influ- ence the future of herbal product.

The years since the DSHEA was first passed has seen an environment where manufacturers have had a relatively free hand with little inter- ference from regulators. The last few years have seen a shift away from this laissez faire mentality. Complaints and concerns from consumers concerning the safety and efficacy of dietary supplement products have resulted in more regulatory scrutiny. The FDA has increasingly used the NDI provision to force pre-market approval. It has also begun to develop a risk analysis system that can use to prohibit the sale of products the orga- nization perceives to be threats to health. In addition, the provisions out- lined in the new cGMPs for dietary supplements have significant effects on the industry.

In Canada, the first major review of the still relatively new NHP regulations is being carried out. The transition into this regulatory scheme

236 Appendix: The herbal regulatory system has not been a smooth one and many issues still need to be addressed.

Foremost among these is the time required for product license reviews and the ramifications the proposed cost-recovery program will entail.

It is clear that consumers want access to these products. But the age-old questions on how a regulatory system can ensure quality, efficacy, safety and accessibility to these products still remain unanswered. Although it is unclear whether the current initiatives in these two countries will ulti- mately answer these questions, one can feel sure that these initiatives will have a considerable effect on the herbal product industry for many years to come.

References

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The uncertain future of herbal product regulation