Traditional Herbal Medicinal Products Directive (THMPD)
The EU law which we know as the Traditional Herbal Medicinal Products Directive (THMPD) was adopted into UK law in November 2005. This marked the start of a transitional period whereby unregistered or unlicensed herbal products existing at the time were allowed to stay on the market. This transition period ended on the 30 April 2011. However, under an agreement with industry, the Government Agency responsible for implementing the Directive in the UK (the ‘Medicines and Healthcare Regulatory Agency’ (MHRA)) allowed retailers to ‘sell through’ herbal medicines that were on the market prior to 30 April 2011 as they estimated a total sell through of products in 18-24 months. However, there were still a number of products on the market in 2013 and despite the best efforts of NAHS, the MHRA had issued a final cut-off date for the sell through of unlicensed herbal medicine of 30 April 2014. After this date all unlicensed products must have been removed from your shelves.
How would I recognize if a herbal product is licensed or registered?
The clearest way is to look for the product license or registration number. This is usually 8 or 9 digits long and is prefixed by PL (Product Licence), PLR (Product Licence of Right) or THR (Traditional Herbal Registration) and printed on the packaging, ie carton and label. Some THR products may also bear the MHRA THR logo but the use of this logo is not mandatory. In addition, the THR logo cannot be used for PL or PLR products and hence, tends to cause further confusion.
Is this product a Herbal Medicine or a Botanical?
The THMPD ruling does not apply to ‘correctly presented botanical food supplements’.
There is currently no legal definition for ‘botanicals’ although the European Food Safety Authority (EFSA) has one of its own, which is remarkably similar to its definition for herbal medicine.
Botanical food supplements are sold under food law: they are generally accepted to optimize or maintain health (herbal medicines have properties preventing or treating disease, or correcting physiological functions) but both food supplements and herbal medicines can affect physiological function and use similar ingredients and forms of presentation.
However, there is also confusion around basic interpretations of what is and what isn’t a herbal medicine, so a product may be designated a herbal medicine in one EU member state and classified a food supplement in another. Similarly, a member state may not classify a product as a medicinal because it contains medicinal herbs.
One of the key criteria for assessing whether a product is medicinal – and assessments are made on a product-by-product basis – is the dosage level. Another important demarcation point is ‘does the product exert a pharmacological effect?’.
You can find a list of all THR Licensed products here:
- Sell through cut-off date
- A Guide to what is a medicine
- Herbal Products as Medicines
- MHRA Guidelines
- List of THRs granted to 2 May 2013
- Nutrition and Health Claims Directive
The latest piece of European legislation to impact the health food industry came fully into force in December 2012. Regulation (EC) 1924/2006 on nutritional & health claims made on foods (NHCR) prohibits the use of claims for all food products unless they are on an approved EU list.
Over the last few years thousands of health claims were submitted to the European Food Safety Authority (EFSA) for assessment in the hope that the majority would make it through the review process. Sadly over 95% of the claims on substances other than vitamins and minerals failed to pass the authorisation process.
In May 2013 the EU finally published the list of approved claims (Regulation (EU) 432/2012) which comprised 222 health claims which could be used on food products including supplements.
A full list of current claims can be found here: https://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/?event=register.home
What does the NHCR cover?
The NHCR applies to all foods intended for the final consumer. It also covers commercial communications designed to promote a food product or to influence consumer choice. This includes product or brand names, labels, brochures, websites, advertising, publicity, testimonials, recommendations by health professionals, point of sale material, catalogues and even verbal communication! The golden rule to remember is that if it is aimed at or is going to be seen or used by your customers then the information must comply with the NHCR.
Business to business communications fall outside the scope of the NHCR, eg manufacturer product information intended for retailers or training materials for retail staff.
What claims can be made for food products?
The list of approved claims mainly relates to vitamins and minerals. This means that as from December 2012 it is no longer permitted to make health claims for ingredients such as glucosamine, enzymes, probiotics, amino acids and many others.
The fate of a large number of claims for botanical extracts such as evening primrose oil or garlic is yet to be decided, they are currently ‘on hold’ whilst EFSA makes up its mind how to they fit in with claims made under the Traditional Medicinal Herbal Products Directive (THMPD). For the time being health claims – not medicinal claims – are still permitted for ‘on hold’ botanical substances.
Generic descriptive terms such as ‘probiotic’ and ‘antioxidant’ are also no longer permitted at the present time.
What information can I give to my customers?
Product compositional and pricing information is outside the scope of the Regulation. Any information or communication for the final consumer which is designed to promote a food product or to influence consumer choice other than to say what it contains or how much it costs must comply with the Regulation. That includes websites, newsletters and in store displays. Make use of the approved health claims for vitamins and minerals where you can, for all other products avoid the use of any statements that may be deemed a health claim, this includes categorising products into health needs such as ‘joint or digestive health’ on a website or in store.
The Advertising Standards Authority (ASA) is the UK’s independent regulator of advertising across all media. They apply the Advertising Codes which are written Committees of Advertising Practice.
The ASA act on complaints and pro-actively check all media to take action against what they deem misleading, harmful or offensive adverts.
The ASA is an independent body funded by a levy on the cost of buying advertising space and direct mailing. They work closely with the Copy Advice Service (CAP) which provides free pre-publication advice to advertisers.
For advertising of Functional Foods:
For advertising of Food and Food Supplements:
For advertising of Antioxidants:
For advertising of Probiotics
For advertising of Anti-ageing claims:
For advertising of Bach and Flower Remedies
For advertising of Organic Foods:
For advertising of Homeopathy:
For Testimonials and Endorsements:
The term homoeopathy comes from the Greek words hómoios, meaning similar, and pathos, meaning suffering or disease and aims to treat the whole person (mental, physical and emotional) and not just the symptoms of the disease or illness. A key premise is that every person has a vital energy or life force which needs to be balanced to promote the body’s self-healing response. When this energy is disrupted or imbalanced, health problems develop.
In homoeopathic medicine the symptoms of an illness are viewed as a direct manifestation of the body’s attempt to heal itself and a homoeopathic substance is given that is capable of producing similar symptoms if it was given to a well person. In so doing, homoeopathy aims to restore the vital energy balance acting as a trigger to stimulate the body’s own natural healing capacity or healing forces.
Under current licensing arrangements homoeopathic products either:
- have Product Licences of Right (PLRs)
- have been granted Certificates under the Simplified Registration Scheme
- have been granted Homoeopathic Marketing Authorizations under the National Rules Scheme.
Since the introduction in the UK of the National Rules Scheme, legislation now requires products with PLRs to be reviewed over a 7 year period from 1 September 2006.
- Brief Guidance for Manufacturers and Suppliers
- Homeopathic Registrations – Authorisations at April 2014
- Homoeopathic Remedies – Legal Selling
- Homoeopathic Remedies – Common Remedies
- Homoeopathic Remedies – Potency
- Labelling Requirements for Homeopathic Products
- Manufacture and Control of Dosage Forms for Homeopathic Products
- Food Information for Consumers Regulation 2014
A new European regulation called the Food Information for Consumers regulation came into effect on 13 December 2014 changing the way information is displayed on Food and Supplements.
What’s different – Food
- Salt replaces sodium in the nutrition tables
- Guideline Daily Amounts (GDAs) will be called Reference Intakes (RIs)
- Recommended Daily Amounts (RDAs) will be called Nutrient Reference Values (NRVs) where applicable
- The order of nutrients in tables will change
- The % RI per portion will be included in the nutrition table on most packs
- Any Allergens present will be highlighted in the ingredients list Food Supplements
- The term Recommended Daily Amount (RDA) used for vitamins and minerals is also changing. You will no longer see % RDA on packs containing vitamins and minerals but instead the % Nutrient Reference Value (NRV). These values are the same.
- The font size may change to make text more visible
- Any Allergens will be highlighted in the ingredients list
Understanding new labels
RI = Reference Intakes
What are Reference Intakes?
Reference Intakes are the new name for Guideline Daily Amounts (GDAs). They are a guide to how many calories and nutrients people should consume each day for a healthy balanced diet.
NRV = Nutrient Reference Values
What are Nutrient Reference Values?
Nutrient Reference Value is the new term for Recommended Daily Amount (RDA).
NRVs are the recommended daily intake of vitamins and minerals for most people.
What’s the difference between Salt and Sodium?
Salt = Sodium x 2.5 (i.e. sodium is multiplied by 2.5 to get salt value).
Under the new regulations, it is a requirement to give the salt rather than the sodium content.
- National Living Wage
[Updated] A new National Living Wage rate of pay came into effect on 1 April 2020
The National Living Wage (for over 25-year-olds) increased 6.2% from £8.21 to £8.72 per hour. The National Minimum Wage also rises across all age groups, including:
- A 6.5% increase from £7.70 to £8.20 for 21-24-year-olds
- A 4.9% increase from £6.15 to £6.45 for 18-20-year-olds
- A 4.6% increase from £4.35 to £4.55 for Under-18s
- A 6.4% increase from £3.90 to £4.15 for Apprentices
What’s the difference between the National Living Wage and Minimum Wage?
The National Living Wage was introduced by the government in 2016 and billed as a higher minimum wage rate for workers aged 25 and over. This pay rate is legally binding.
The previous National Living Wage was £8.21, having risen from £7.83.
The minimum wage is a wage rate released by the government is a negotiated settlement based on recommendations from trade unions and businesses.
The rise followed the Conservatives’ promise during its annual conference last September to increase the National Living Wage to £10.50 an hour over the next five years if ‘economic conditions allow’.
The real living wage is an independently calculated wage rate which aims to be higher than the cost of living in the UK and London. Calculated by the Living Wage Foundation, it takes into account rental costs, council tax, shopping costs and travel costs.
Companies are not legally obliged to sign up to the real living wage but can become an accredited real living wage employer if they choose to do so.
The current real living wage for people living in London is £10.75, £1.45 more than the real living wage for the rest of the UK.
Although the government has set the initial amount, going forward the amount of the NLW will be determined by the independent Low Pay Commission, in the same way that it makes recommendations for changes to the NMW.
Other changes include greater penalties for failure to pay the NMW and NLW, with penalties increasing to 200% of arrears, which are halved if the employer pays the outstanding amount within 14 days. The maximum penalty of £20,000 per worker remains unchanged. Retailers should also be aware that a new HMRC team is being set up with the purpose of chasing up the most serious cases where employers have deliberately not paid the NMW or NLW. The team will be able to impose penalties, refer matters to the Crown Prosecution Service for prosecution and “name and shame” the worst offenders. High risk areas for targeting include retail and hairdressing sectors. Company directors may also be disqualified from being a director for up to 15 years if they breach the legislation.
A new position will be created called the Director of Labour Market Enforcement and Exploitation, which will oversee enforcement of the NMW and NLW, the Employment Agency Standards Inspectorate and the Gangmasters Licensing Authority. Further consultation is also expected on the introduction of a new offence of aggravated breach of labour market legislation. The government is also proposing to expand the Gangmasters Licensing Authority’s investigatory powers in order to tackle serious labour exploitation.
Employers should ensure they comply with the new legislation. This should include:
- Checking that all staff are paid the current correct amounts for the hours they work
- Checking that the data they have in relation to date of birth is accurate
Please check the government website https://www.gov.uk/national-minimum-wage-rates for further information and guidelines on the NMW and the NLW.
- EU Distance Selling logo (previously the Common Logo) (Licensed Medicines)
[Updated] From 1 July 2015 anybody in the UK selling medicines (including licensed herbal or homeopathic medicines) online to the general public needs to be registered with the MHRA and to be on the MHRA’s list of UK registered online retail sellers. They also need to display on every page of their website offering medicines for sale, the new European Distance Selling logo which is registered to the seller.
The Distance Selling logo must be displayed on every web page that offers to sell medicines to the public. If you are selling a medicine through a third-party marketplace website, you must include the Distance Selling logo on each and every page of your listings where you offer medicines for sale to the public. The registered EU Distance Selling logo will contain a hyperlink to their entry in the MHRA’s list of registered online sellers. Anybody buying medicines online can check if the website is legitimately registered and will be able to click on the logo which will take them through to a list of approved sellers.
The penalty for selling medicines online without being registered and not displaying the logo is up to 2 years in prison or a fine or both.