Controlled substances and UK law

[Kate]

Does anyone know how substances become controlled substances in law? The closing of the nicotine market and making illegal anything not tobacco or medicine seems like it's being made a controlled drug to me.

I'm very concerned about the prejudiced wording and shoddy drafting of the MHRA consultation, folks seem to think they're voting for one of three options and one of them isn't even true.

I think there's a good case to challenge the jurisdiction of MHRA to legislate and control a drug that has previously been on the open market.

Anybody got thoughts on this?

[Kate]

, Ian was posting this at about the same time I started this thread - http://ukvapers.com/showthread.php?p=7311#post7311

[Kate]

Does anyone want to ask MHRA why option 3 in the consultation is not true? As well as the provisions of the Poisons Act 1972, this regulation currently covers safety of commercial nicotine: http://vapersnetwork.org/forum/showthread.php?tid=164

[Kate]

This is from the MHRA consultation:

Quote:Rationale for Government Intervention
... There are, however, a number of products (including some electronic cigarettes) purporting to contain nicotine that are widely and easily available but are not licensed medicines. Because of their “legal status”, it is difficult to get information on quality, safety and/or efficacy of these NCPs, and to know whether the clear benefit to risk that has been established for NRT products can be attributed to them.
The MHRA is consulting on whether action should be taken to bring all these products within medicines legislation by function in the light of the current usage of NCPs.

The logic here is so warped I think it could be faster than the starship Enterprise.

'She cannae tak it any longer capin'



This is the only valid point and the answer is to have international standards established so the current regulations can be applied - "... it is difficult to get information on quality, [and] safety ..."

I view standards being the responsibility of Trading Standards officers, they are the ones who should be enforcing them now.

[Kate]

This is what TSI, CIEH and LACORS said covers the regulation of ecigs:

Quote:... currently in order to be sold legally in the UK, e-cigarettes are required to meet the requirements of the General Product Safety Regulations 2005 and associated safety regulations.

http://vapersnetwork.org/forum/showthread.php?tid=164
http://www.berr.gov.uk/files/file22713.pdf

Quote:There is no recognised standard or safety specific regulations for this product

http://vapersnetwork.org/forum/attachment.php?aid=4



Standards have to be created for new products and this is the place that does it - http://standardsproposals.bsigroup.com/H...estNewArea
http://vapersnetwork.org/forum/showthread.php?tid=174

Strangely enough, new inventions don't get born with standards but not all get taken off the market because of that


The Poisons Act 1972, CHIP packaging regulations and CE regulations also apply.

[Kate]

I sent this to TSI, CIEH and LACORS on Friday:

Quote:Consumer protection and nicotine products

Hi

Please could you tell me what has been done to satisfy the conditions regarding the General Product Safety Regulations 2005 and consumer nicotine products that are not currently classed as tobacco or medical products?
http://www.berr.gov.uk/files/file22713.pdf

Have there been any moves to define 'safe' and establish standards for these products?
http://vapersnetwork.org/forum/showthread.php?tid=174

Thank you
Kate ***

[deewal]

You could also ask ASH UK what happened to this.
ASH UK have already stated in Document ASH_715.pdf available on their website.......

ASH’s position on e-cigarettes

ASH supports a harm reduction approach to tobacco, that is, we recognise that whilst

efforts to help people stop smoking should remain a priority, many people either do not wish

to stop smoking or fi nd it very hard to do so. For this group, we believe that products should

be made available that deliver nicotine in a safe way, without the harmful components found

in tobacco. Most of the diseases associated with smoking are caused by inhaling smoke

which contains thousands of toxic chemicals. By contrast, nicotine is relatively safe.

Therefore, e-cigarettes, which deliver nicotine without the harmful toxins found in tobacco

smoke, are likely to be a safer alternative to smoking. In addition, e-cigarettes reduce secondhand

smoke exposure since they do not produce smoke.

There are, however, a number of problems with e-cigarettes.

1. Most deliver a low dose of nicotine which may not give a typical smoker a suffi cient

‘hit’ to satisfy cravings, discouraging smokers from continuing to use them.

2. Because the products are unregulated there are some concerns about their safety

since few manufacturers disclose the ingredients of their products.

3. So far, there have been no clinical trials to prove that they can help people to stop

smoking. In the absence of such evidence, ASH therefore recommends that people who

want to quit smoking should use nicotine replacement therapy or other proven

pharmacological aids such as Champix (varenicline) or Zyban (bupropion).

Regulation

The UK’s Medicines and Healthcare Regulatory Authority (MHRA) has ruled that certain

brands of e-cigarettes cannot be classifi ed as medicinal products and therefore do not fall

under the remit of the MHRA. Although rulings are made on a case by case basis, it is likely

that the same ruling would apply to similar products. Currently, e-cigarettes are subject to

general consumer protection Iaws and it is the responsibility of trading standards offi cers to

rule on their safety.



Now the MHRA have changed their stance but as far as i am aware ASH UK has not Published an Addendum or Update to this Document.



By now we all know that Johnson and Johnson who are owned by GlaxoSmithKline who produce Nicorette have applied for a Licence for their "New Improved etc, etc" and had it granted by the MHRA who now wish to crush the opposition. ASH UK must be aware of this and are keeping their heads down as GlaxoSmithKline also just happen to own a large stake of The Phillip Morris Company who manufacture the Product which ASH was formed to fight against.

[Kate]

No word back yet from TS, LACORS or CIEH.

The MHRA tells me that their proposals do not amount to making nicotine a controlled substance.


Just for reference in case anybody needs to know, currently at least these regulations apply to commercial sale of PVs:

CHIP - refers to the Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 - http://www.hse.gov.uk/chip/index.htm

The Poisons Act 1972 - http://www.opsi.gov.uk/RevisedStatutes/A...20066_en_1

CE certification requirements - http://www.berr.gov.uk/whatwedo/sectors/...11646.html

The General Product Safety Regulations 2005 - http://www.berr.gov.uk/files/file22713.pdf

The last one says:

Quote:Meaning of a Safe Product
3.1 A “safe product” is any product which under normal or reasonably foreseeable conditions of use presents no risk or only the minimum risk compatible with the product’s use and which is consistent with a high level of protection for consumers.
3.2 While the Regulations do not apply to the safety of services per se, the safety of some products (e.g. certain machinery and gas appliances etc) is dependent on how they have been installed and maintained. These services are an essential feature of the safety of the product and may form part of the contract to supply the product. As such they will be taken into account when judging whether the product is a safe product.
3.3 The safety of a product will be assessed having regard to a number of matters and, in particular:
l the product’s characteristics;
l packaging;
l instructions for assembly and maintenance, use and disposal;
l the effect on other products with which it might be used;
l labelling and other information provided for the consumer; and
l the categories of consumers at risk when using the product, particularly children and the elderly.
3.4 The existence of higher levels of safety, or availability of products presenting lesser risk, will not in itself mean that a product is unsafe.

Minimum risk compatible with the product’s use which is
consistent with a high level of protection for consumers

9. It must be recognised that it is not always possible to eliminate all risk from products. Certain products, by the very nature of their intended purpose, carry an inherent safety risk and consumers must accept that they have a responsibility to exercise due care in using such products. Examples are knives and scissors, which must have sharp edges to perform their function but where reasonable precautions can be taken to ensure that handles are sturdy and hands are kept away from the functional edges when such items are in use. In other cases, it could be argued that consumers should be aware of the potential risks of misuse through general knowledge, education and experience. Thus, a balanced view must be taken based on the nature of the product and the acceptability of the risk to consumers based on the characteristics of the product and its use. The range of potential hazards which may need to be drawn to consumers’ attention will depend on a number of factors (referred to in the section above on ”Labelling”)...

[Kate]

EDIT: Jump to next post, this one isn't accurate.



LACORS have said this:

Quote:There is already a definition of what constitutes a safe product within existing product safety legislation - http://www.opsi.gov.uk/si/si1994/uksi_19942328_en_1.htm

I can't really concentrate on reading this at the moment so have no analysis but here's a bit of what it says:

Quote: General safety requirement
7. No producer shall place a product on the market unless the product is a safe product.

Requirement as to information
8.—(1) Within the limits of his activity, a producer shall—
(a) provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warnings, and to take precautions against those risks; and
(b) adopt measures commensurate with the characteristics of the products which he supplies, to enable him to be informed of the risks which these products might present and to take appropriate action, including, if necessary, withdrawing the product in question from the market to avoid those risks.
(2) The measures referred to in sub-paragraph (b) of paragraph (1) above may include, whenever appropriate—
(i) marking of the products or product batches in such a way that they can be identified;
(ii) sample testing of marketed products;
(iii) investigating complaints; and
(iv) keeping distributors informed of such monitoring.

Requirements of distributors
9. A distributor shall act with due care in order to help ensure compliance with the requirements of regulation 7 above and, in particular, without limiting the generality of the foregoing—
(a) a distributor shall not supply products to any person which he knows, or should have presumed, on the basis of the information in his possession and as a professional, are dangerous products; and
(b) within the limits of his activities, a distributor shall participate in monitoring the safety of products placed on the market, in particular by passing on information on the product risks and cooperating in the action taken to avoid those risks.

Presumption of conformity and product assessment
10.—(1) Where in relation to any product such product conforms to the specific rules of the law of the United Kingdom laying down the health and safety requirements which the product must satisfy in order to be marketed there shall be a presumption that, until the contrary is proved, the product is a safe product.

(2) Where no specific rules as are mentioned or referred to in paragraph (1) exist, the conformity of a product to the general safety requirement shall be assessed taking into account—
(i) voluntary national standards of the United Kingdom giving effect to a European standard; or
(ii) Community technical specifications; or
(iii) if there are no such voluntary national standards of the United Kingdom or Community technical specifications—
(aa) standards drawn up in the United Kingdom; or
(bb) the codes of good practice in respect of health and safety in the product sector concerned; or
(cc) the state of the art and technology and the safety which consumers may reasonably expect...

[Kate]

Oops ... LACORS accidentally sent me the wrong link, these are the regulations that they say apply:

http://www.opsi.gov.uk/si/si2005/uksi_20051803_en.pdf