Before the furore over the now defeated proposed ban of vitamin B6 has even cooled down, the British government has been quietly working away at a new scheme to get vitamins and alternative medicine under its thumb. This new measure comes with consultation letter MLX249, a proposed amendment to give it a broad new range of powers over herbs and vitamins.
Under the new proposal, the Medicines Control Agency (MCA) would have the right to immediately classify as medicines many products on health food shelves, chiefly those containing herbs and herb/vitamin preparations.
Once it makes a provisional determination that a product is medicinal in nature, the manufacturer has a scant two weeks to request an oral hearing and 28 days in which to present written evidence in support of the efficacy of its product. An oral review of the evidence would take place between three and nine weeks later.
The review committee would operate with a permanent chairperson from the MCA, plus two so called “experts” from the relevant field. The committee’s final decision in the oral review would be considered “sufficient evidence” in any subsequent legal proceedings unless demonstrated to be “unreasonable” .
The Health Food Manufacturers Association believes that, if adopted, the proposal will turn the MCA into “judge, jury and executioner” with “no checks and balances”.
If put into effect on April 1, as planned, the proposals will give the MCA immediate licence to remove many top selling herbs and herbal/vitamin preparations from the shelves of health food stores. Even single herbs are being targeted, as the MCA is attempting to remove an exemption in the Medicines Act which allows their unregulated sale. This could mean that it will be impossible to get hold of such perennial remedies as echinacea and hypericum, unless the manufacturers can provide proof of their efficacy to the MCA’s liking. The MCA is also considering revising the lists of herbs prohibited for open sale.
Naturally, according to the National Association of Heath Stores, neither the NAHS nor any other herbal organisations were consulted at the time of the writing of the Statutory Instrument proposing the change to UK law. Although the MCA employed its usual surprise attack methods, springing the proposals with a short deadline for closure of consultation, the NAHS urged a one month extension, to the end of January 1999.
This move follows pressure from Europe to vigorously regulate the sale of herbs and “borderline” products. One strong impetus was an investigation of wild yam products, many sold by mail order, after complaints that some manufacturers of these products added manufactured progesterone to the preparation. Wild yam on its own doesn’t contain progesterone and cannot be converted by the body into the hormone. The HAHS counters that consumers would be better off with herbal products continuing to remain under food law. The Health Food Manufacturers Association is pursuing ideas with the Birtish Herbal Medicine Association for a registration procedure that will better suit the herbal market.
There is no doubt that herbal products should be better regulated and standardised, and we for one support any move that would prevent progesterone and the like to be secretly added to products. Many herbal/vitamin combinations are virtually useless and are an elaborate confidence trick. However, this draconian measure would put natural substances into the same category as drugs. In our view, the makeup of the products, and their uses cannot be compared, since few herbs have been subjected to the same kinds of scientific studies as pharmaceuticals. If the government is going to insist on such proof, it should provide the resources to do so.
Unless you want the government to control whether you can buy echinacea to combat a cold, get your pens out and write to your MP, before the government achieves what it clearly intends to be a fait accompli.