Regulations on herbal medicines come into force

What is so interesting about the 'spin' on this article is that there is a focus on some disturbing concerns -

On the one hand people are referred to their doctor or pharmacist for information.  Quite frankly too few doctors and pharmacists are educated in natural remedies and would not be the go to source of choice in my opinion.

The concept that the reason for licensing natural remedies is to protect people is specious. There is no mention of any rule to protect people from the oft deadly and serious side effect causing from pharmaceutical drugs.

Citing blood thinning drugs and blood thinning herbs says that there is little concern about the fact that consumers can get the benefit without drugs.  The profit motive again.

Many real health freedom fighters have been trying to fight this and educate the public about the issues for more than a decade as I have.

The concern is that this will happen in the US as we see the push to get you to accept "integrative medicine" and forgo hundreds of years of safety and efficacy of natural remedies.  These same natural remedies used for so long and the basis of the National Formulary and USP.

Contact us for herbal education and highest quality remedies.

The EU law aims to protect consumers from possible damaging side-effects of over-the-counter herbal medicines.  For the first time, new regulations will allow only long-established and quality-controlled medicines to be sold.  But both herbal remedy practitioners and manufacturers fear they could be forced out of business.

Herbal remedies that have been approved for sale under the new regulations will come with this logo

To date, the industry has been covered by the 1968 Medicines Act, drawn up when only a handful of herbal remedies were available and the number of herbal practitioners was very small.

But surveys show that around a quarter of all adults in the UK have used a herbal medicine in the past two years, mostly bought over the counter in health food shops and pharmacies.

The regulations will cover widely used products such as echinacea, St John's Wort and valerian, as well as traditional Chinese and Indian medicines.

But safety concerns have focused on the powerful effects of some herbal remedies, as well as the way they interact with conventional drugs.

For example, St John's Wort can interfere with the contraceptive pill, while ginkgo and ginseng are known to have a similar effect to the blood-thinning drug warfarin.

From now on only products that have been assessed by the Medicine and Healthcare products Regulatory Agency (MHRA) will be allowed to go on sale.

Manufacturers will have to prove that their products have been made to strict standards and contain a consistent and clearly marked dose.

And to count as a traditional medicine, products must have been in use for the past 30 years, including 15 years within the EU.

They will also only be approved for minor ailments like coughs and colds, muscular aches and pains, or sleep problems.

Remedies already on sale will be allowed to stay on the shelves until they reach their expiry date.

Free from contamination

Richard Woodfield, head of herbal medicine policy at the MHRA, says so far there have been 211 applications, of which 105 have been granted registration.

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"Crucially, this EU directive and the registration scheme puts consumers in the driving seat so they can identify that a product meets assured standards on safety, quality and information about safe use.

"Safety speaks for itself, but quality means, are they using the right part of the plant? Is it free from contamination? Is the claimed shelf life suitable?

"Product information will include possible side effects and interactions with other drugs, but above all it must make very clear that it is based on traditional use."

And that is a key point for the Royal Pharmaceutical Society, which believes the new regime is a step forward in improving safety and quality.

But Prof Jayne Lawrence, chief science adviser to the society, says there are still some concerns about herbal products.

"They certainly haven't been tested on the same basis as a conventional medicine and some of these compounds are very potent.

"Patients might not realise that in some cases they should not take other medicines with them, or if they're going for surgery they should tell their doctors they are taking these particular medicines because there may be complications.

"So we're very concerned that patients appreciate they must be very careful when they take these medicines and, ideally, should talk to their doctor or pharmacist."

The manufacturers of herbal remedies have had seven years to prepare for the new rules after the European Directive on Traditional Herbal Medicinal Products was introduced in 2004.

Too onerous?

These regulations apply to over-the-counter sales, which form the bulk of herbal remedies sold in the UK.

But some manufacturers and herbal practitioners have expressed concern, arguing the new rules are too onerous for many small producers.

Michael McIntyre, chairman of the European Herbal and Traditional Medicines Practitioners Association, says there will be a significant impact on herbal medicine practitioners and their suppliers, but admits the rules do need bringing up to date.

"Products that go on the market now will definitely do what it says on the bottle, while we didn't know how good they were in the past.

"But registration is expensive so perhaps there may be fewer products on the market and a smaller range.

"It's difficult to argue that the market should stay as it is, without any regulation, but how many businesses will pack up and walk away? I can't say."  SOURCE

Some old news from the beginning of the decade -  I cannot speak for veracity of the information however it is interesting to consider -

Supreme Court bans medicinal use of aloe plant

Washington, D.C. -- The U.S. Supreme Court unanimously ruled Monday that people using the aloe vera plant for medicinal purposes are not exempt from federal laws prohibiting use of the naturally occurring herb, which medical experts say can ease the suffering of burn victims.

"It is clear from the text of the [controlled substances law] that Congress has determined the aloe vera plant has no medical benefits worthy of an exception," Justice Clarence Thomas wrote for the court.

The Supreme Court's decision reversed a 1996 Ninth U.S. Circuit Court of Appeals ruling that medical necessity can be a legal, "common law" defense to prosecution. Both raw aloe and the aloe vera plant were included in the 1966 U.S. Controlled Substances Act, classifying aloe as a Class II Narcotic alongside cocaine, marijuana, LSD and other substances that invoke feelings of euphoria in the user.

Public controversy surrounding aloe's legal status has escalated since California's 1996 passing of Proposition 215, which authorized doctors to prescribe aloe as a medicinal aid for certain health ailments - an authorization in direct conflict with the Controlled Substances Act. With doctor's orders, patients could legally purchase, use and in some cases even grow aloe vera plants, the leaves of which yield a thick sap that can be used to relieve the pain generated by some skin conditions.

"The Court of Appeals" action cannot be squared with a federal law that bans aloe because of its potential for abuse," Justice Thomas wrote.

Aloe legalization activists, having long questioned the inclusion of aloe in the Controlled Substances Act, say authorities are acting out of drug paranoia in the continued suppression of aloe's legality.

"It's unfortunate the Supreme Court used faulty logic, following along with the drug war, rather than seeing the legalization of aloe for what it is: a health care issue," said Santa Clara University law professor Gerald Uelmen, spokesman for Legalize AV!, a pro-aloe activist organization. "Aloe can relieve the pain that accompanies oxidation of a burn wound. Further, there is evidence that aloe can aid digestion and be used as a healing agent for digestive problems."

"No one's asking for full-blown aloe legalization - not in this case, anyway," added Uelmen.

Pro-aloe activists insist that since aloe plants occur naturally in the environment, use of the plant and its extract should not be - and in theory, cannot be - controlled. It is believed that as much as 40 percent of the nation's populace illegally uses aloe in their homes.

Legalize AV! volunteer and pro-aloe activist Kendra Kelly said she disagrees with the government's position that it is legal to use manmade antiseptics like hydrogen peroxide and isopropyl alcohol - which often incite hostile reactions in the user - while aloe remains a controlled substance.

"It's like, aloe comes right from the earth, like it's nature's gift to humanity; that it's illegal just blows my mind," said Kelly, who admits to occasionally purchasing aloe for her personal home use. "Aloe is like the mildest [of antiseptics]. When I use aloe, it's like, 'Ooh, yeah.' It totally mellows me out. Not like [hydrogen] peroxide. That shit makes me scream."

Kelly refused to elaborate on the events surrounding her two arrests for medicinally using aloe vera, having been cited for aloe possession in 1977 when police searched Kelly's car after suspecting she had recently used aloe, and again at a college party in 1983 when "a whole bunch of [students] were out back getting burned."

November 2001

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