The Medical Products Agency bases its classifications on an overall assessment of each individual product. The information below should therefore be regarded only as guidance in what is or is not classified as a medicinal product.
When classifying a product, the Medical Products Agency begins with the definition of a medicinal product. In classification, the term medicinal product covers synthetic and herbal medicinal products as well as natural remedies, traditional herbal products, certain externally-applied medications and homeopathics.
Products not classified as medicinal products by the Medical Products Agency may be covered by other legislation. For nutritional supplements, for example, it is thus important to contact the Swedish National Food Administration regarding information about permitted ingredients and health claims.
In its classification work, the Medical Products Agency takes account of:
- Claims made either directly or indirectly about the product, including that said or implied in the product name,
- pharmacological properties of the ingredients,
- wording on the packaging, images and leaflets,
- marketing materials (brochures, written advertising copy, etc.), word-of-mouth information, etc.,
- the product’s prepared form (tablet, capsule, etc.), how it is to be used and its dosage,
- if similar approved medicinal products already exist on the market.
How are the following classified?
- adaptogens (e.g. ginseng and roseroot)
The Medical Products Agency has found that roseroot (Rhodiola rosea) and shisandra (Shisandra chinensis) have documented application in healthy individuals. Tablets etc. containing ginseng, roseroot or shisandra can therefore be sold as foodstuffs/nutritional supplements. However, if the products are marketed with the use of medicinal claims, they are classified as medicinal products.
- androstenedione, DHEA and other testosterone precursors
The Medical Products Agency has the opportunity to apply the Medicines Act even for products not intended to prevent, treat or cure diseases or their symptoms if the product characteristics closely resemble a medicinal product. The Medical Products Agency has done so regarding, for example, the testosterone precursors androstenedione and DHEA (dihydroepiandrosterone), see the Medical Products Agency statute LVFS 1995:9. One consequence of this is that the import or sale of products that contain these substances is prohibited.
Other testosterone precursors that are not to be used for medicinal purposes are not classified as medicinal products but can be covered by other provisions. The Medical Products Agency considers such products to be a danger to health.
- amino acids
Products that contain amino acids and that can be taken as a nutritional supplement can be sold as foodstuffs. Amino acid supplements for patients with the metabolic disease phenylketonuria (PKU) are considered as foodstuffs for special medicinal use and must be registered at the National Food Administration before they can be sold.
One exception is products containing the amino acid tryptophan, which is classified as a medicinal product. However, this does not apply to tryptophan that occurs natural in proteins or food for special nutritional needs.
- slimming products
Slimming products are normally classified as foodstuffs. The following slimming products are, however, classified as medicinal products:
- products for treating excess weight/obesity
- products intended to counteract overweight by speeding up the passage of food through the intestine (laxatives), to numb the taste sensation or reduce appetite if the product can be considered to act directly on the central nervous system, or inhibit enzymes that break down fat, carbohydrate or proteins in the stomach and/or intestine.
Several examples of ingredients that can lead to classification as a medicinal product due to the mechanism of their medicinal effect are listed below:
- Hoodia gordoni
- Synephrine >160 mg/day (found in Citrus aurantium)
- Forskolin (found in Coleus forskohlii)
- Phaseolamin (found in Phaseolus vulgaris)
- disinfectants
Disinfectants are primarily classified as biocides or medicinal products. Disinfectants used on patients, e.g. prior to an operation, on damaged skin or diseased animals, are classified as medicinal products. Even other disinfectants used in healthcare, e.g. preoperative hand cleansers, are classified as medicinal products if their prophylactic effect against specific infections is given.
Products intended for general disinfection of hands are not classified as medicinal products but instead as biocides. For instance use of the claim ‘effective against hepatitis B-virus’ is allowed for these products. Marketing products as offering protection against infections caused by the hepatitis B-virus does, however, lead to their classification as a medicinal product.
The Swedish Chemicals Agency is the supervisory authority for biocides.
- ephedra extract/ephedrine
As of September 1st, 2005, all products that contain ephedrine or ephedra extracts are covered by the Medicines Act. All products that contain ephedrine are classified as medicinal products.
- electric cigarettes/e-cigarettes
Electric cigarettes/e-cigarettes comprise a ‘plastic cigarette’ that is charged in the same way as a mobile phone. It is then equipped with ampoules/filters of various content. During use, the cigarette ‘glows’ and water vapour is formed.
The Medical Products Agency classifies the ampoules/filters and not the ‘cigarette’.
If these contain no nicotine whatsoever (i.e. only flavours) they are not classified as medicinal products and neither as tobacco products. The products are not subject to any special legislation.
If they contain pure nicotine, they are classified as medicinal products and cannot, therefore, be sold on premises not approved for such products. Nicotine has a well-known pharmacological effect on the body and products containing pure nicotine are thereby classified as medicinal products according to Point 2 in the Definition of Medicines. Ordinary cigarettes are classified as tobacco products. Tobacco legislation covers only products that contain parts of the tobacco plant, not products that contain pure nicotine.
The classification of filters/filters that contain pure nicotine as medicinal products applies irrespective of their intended use as stated by the seller.
- fish oil
Towards the end of 2007, the Medical Products Agency made a renewed assessment of omega-3 fatty acids. The information given below describes the starting point for the agency’s current classification of omega-3. This should be regarded as guidance only since classification is made on an overall assessment of each individual product.
- Omega-3 fatty acids in the form of triglycerides, free fatty acids or ethyl esters are considered foodstuffs as long as the daily dose of omega-3 fatty acids does not exceed 3 gram (measured as triglycerides) and as long as no medical claims are made. Methyl esters have also been named in earlier documentation but at the moment the Medical Products Agency is not aware of any such products currently on the market.
- Fish oil products with a daily dose of omega-3 fatty acids that exceeds 3 gram (measured as triglycerides) are classified as medicinal products.
- If medical claims are made for a product, the following applies.
- Omega-3 fatty acids in the form of triglycerides are considered medicinal products. They may possibly gain approval as natural remedies if the requirements for this are fulfilled. For all natural remedies, approval is based on proven experience (epidemiological data) and not on the results of product-specific studies. Approval should be seen against the background of current general knowledge of the connection between diet and health.
- Omega-3 fatty acids that are chemically-modified to free fatty acids and ethyl esters are considered medicinal products but since these products are chemically modified, they cannot be approved as natural remedies. The Medical Products Agency deems that the effect and safety of this type of fatty acid cannot be based on proven experience of high levels of fish consumption and fish oils containing naturally-occurring fatty acids in the form of triglycerides. Product-specific documentation is thus required for classification as a medicinal product.
- fluoride products
Toothpaste can contain fluoride to a maximum content of 0.15% according to the regulations for cosmetic and hygiene products. Such toothpastes can be marketed with the claim that they ‘prevent caries’. Toothpaste with a fluoride content exceeding 0.15% is classified as a medicinal product.
Sodium fluoride is covered by the so-called nutritional supplement directive as a substance that can be included in nutritional supplements. The Medical Products Agency has deemed that a chewing gum with a lower content of fluoride can be sold under foodstuffs legislation.
Dental products with a typical technical function, e.g. cement and lacquer, are to be regulated as medical devices if the fluoride content in the product has a supportive function in relation to the product function.
- glucosamine
Preparations containing glucosamine are classified as medicinal products since the intention of these products is medicinal (treating troublesome joints). The products cannot be classified as natural remedies since the glucosamine is far too purified. Several approved medicinal products containing glucosamine are found today.
- lubricants and condoms
Lubricants and condoms are classified as medical devices. Lubricants with spermicidal substances are regulated according to the Medicines Act.
- homeopathics
Homeopathics are classified as medicinal products. Products are considered homeopathic medicinal products if, for example, they are marked ‘homeopathic’ or if they are stated to have been manufactured using homeopathic methods or if they are labelled with information on degrees of dilution e.g. D6, LMII, X200.
- caffeine
Classification is based on an overall assessment of each individual product.
- creatine
Creatine used in conjunction with performing sporting activities is classified non-medicinal.
- liniment
Liniment and related products can be classified as cosmetic and hygiene products, medicinal products or medical devices depending on their content and use. Products containing substances intended to relieve pain via a pharmacological effect are classified as medicinal products. Examples of such substances can be cayenne pepper extract, methyl salicylate and bee venom. Certain substances can be considered to have a cosmetic purpose in low amounts even if they have a medicinal purpose in higher amounts. For example, 3% camphor is normally accepted in a cosmetic and hygiene product, as is 5% menthol.
‘Cooling’ and ‘warming’ are expressions that can be accepted when marketing cosmetic and hygiene products.
Liniment that acts by warming, cooling or relieving pain and where this function is not achieved via a pharmacological mechanism of action or equivalent can also be considered medical devices.
- substances for aquarium fish
Substances for treating aquarium fish are not considered medicinal products. Substances for treating fish for human consumption are, however, considered as medicinal products.
- insect repellents
Repellent substances, e.g. mosquito repellent, are considered biocides. Lethal substances intended for animals, e.g. tick products for dogs, can also be considered biocides as long as no medical claims regarding subsequent diseases are made. The Swedish Chemicals Agency is the authority that oversees biocides. Lethal substances intended for use on humans are classified as medicinal products. Lice powder is one example. In certain cases, this type of product can instead be considered as a medical device if the lethal mechanism is not pharmacological, immunological or metabolic.
- melatonin
Products containing melatonin are classified in Sweden as medicinal products. The reason being that melatonin is used for medicinal purposes, e.g. during sleep disturbances.
- ‘poppers’
The Medical Products Agency has decided that the Medicines Act shall cover products that contain isoamylnitrite, n-amylnitrite och isobutylnitrite (‘poppers’). One consequence of this decision is that the import or sale of such products is prohibited.
- probiotics (‘lactobacteria’)
At the beginning of 2008, the Medical Products Agency made a renewed assessment of probiotic bacteria in capsules, tablets and similar.
When classifying capsules, tablets and similar containing probiotics, the Medical Products Agency’s basic viewpoint is that these cannot currently be classified as medicinal products if no medicinal claims are made. However, products that, for example, contain strains for which there is no food use can be classified as medicinal products based on their medicinal intention. Classification is based on an overall assessment of each individual product. The National Food Administration may also have views on which strains can be included in foodstuffs, including nutritional supplements. Several approved natural remedies that contain lactobacteria can be found.
- products intended to improve sex life
Preparations intended to prolong erection should be classified as medicinal products. This applies both to products for external use (absorbed by the body) and products that are swallowed.
Products for treating impotence or that are compared with approved products for impotence in marketing material are also classified as medicinal products.
- products for treating diseases of honeybees
Products for treating diseases of honeybees are now classified as medicinal products. Examples of such products are so-called beehive strips impregnated with pyrethroid for combating varroa mites and fumagillin B for combating nosema mites. Organic acids used in the management of honeybees are, however, not classified as medicinal products.
- smoking cessation products
Products containing nicotine to be used for smoking cessation are classified as medicinal products as the aim of the products is to relieve withdrawal symptoms. Other smoking cessation products can also be classified as medicinal products. An overall assessment is made based on the product’s contents and presentation.
- training products
The Medical Products Agency always makes a classification ruling of specific products and consideration is taken regarding ingredients, dosages, the intention of the product, etc. The list given below should be seen only as examples of ingredients that can influence how a product is classified. It is based on questions commonly asked of the Medical Products Agency.
Contents that do not normally lead to a medicinal product classification
Products that only contain any of the following substances are not normally classed as a medicinal product (assuming that they are not presented as a medicinal product):
- vitamins and minerals
- amino acids (with certain exceptions for tryptophan)
- whey extract
- creatine
- fatty acids
Contents that can lead to a medicinal product classification
Products that, for example, contain any of the following substances are normally deemed to be a medicinal product:
- 5-hydroxytryptophan (5-HTP)
- Acetyl cysteine (NAC)
- Androstendione*
- DHEA*
- Devil´s claw (Harpagopytum procumbens)
- Ephedrine, ‘Ephedra’ *
- Epitiostanol
- Forskolin (Coleus forskolii)
- GABA*
- Ginkgo biloba
- Glucosamine
- Hoodia (Hoodia gordonii)
- Idebenone
- St. John’s Wort (Hypericum perforatum) ‘
- Silymarin (Silybum marianum) ‘milk thistle’
- Melatonin, N-acetyl-5-metoxytryptamine
- Mucuna pruriens, L-dopa
- Octopamine
- Phaseolamine (Phaseolus vulgaris)
- Purple coneflower (Echinacea purpurea)
- Salicylic acid, Salix alba, White Willow bark
- Saw palmetto (Serenoa repens/Sabal serrulata)
- Cat’s claw (Uncaria tomentosa)
- Vinpocetine/ Vincamine
- Valerian (Valeriana officinalis)
- Yohimbe/ yohimbine
* See Statute LVFS 1995:9, revised and reprinted 2001:2 and revised 2005:8 under Legislation and regulations in the right-hand margin.
- vitamins and minerals
Nutritional supplements containing vitamins and minerals intended to complement the daily diet are considered foodstuffs. There are currently no limiting amounts for classifying vitamin/mineral preparations as medicinal products.
If the aim of the vitamin/mineral preparation is medicinal, i.e. to treat deficiency symptoms, the product is classified as a medicinal product. A number of approved medicinal products containing vitamins and minerals can be found today.
There is also an EU directive that deals with nutritional supplements. This includes a list of the vitamins and minerals that are permitted in nutritional supplements. Upper and lower amounts are not yet set. These will be worked out later. For more information, see the National Food Administration’s website.
- garlic
At the beginning of 2008, the Medical Products Agency made a renewed assessment of garlic in capsules and tablets. When classifying capsules and tablets containing garlic, the Medical Products Agency’s basic viewpoint is that these cannot currently be classified as medicinal products if no medicinal claims are made. The renewed assessment was made, among other reasons, against the background of the EU court’s ruling of Nov 15th, 2007, Commission versus Germany, C-319/05. An assessment is nevertheless made for each individual product. For example, the dose can be crucial for a product’s classification. Several approved natural remedies that contain garlic can be found.
- fluid replacement
So-called fluid replacement preparations intended to restore the electrolyte balance (salt balance) following diarrhoea and similar are classified as foodstuffs.
- eye drops containing vasopressor substances
Eye drops containing naphazoline, tetrahydrozoline or similar vasopressor substances are classified as medicinal products. The aim of eye drops containing vasopressor substances is to treat the redness that can arise from, for example, allergy or irritated eyes.