In the price of licensing, NAFDAC is concerned mainly with the regulation and control of labeled package products or finished herbal medicines in this case.
We must distinguish between accepted traditional compounds that are well known, whose decades of safe use attest to their safety (e.g. valerian, menthol, eucalyptus, rhubarb, camphor, chamomile, senna, ginseng, gingobiloba, (etc.) from unknown compounds. Unknown crude plant extracts or mixtures could contain toxic components that may not easily be assayed. It is important for producers to be transparent in their labeling by listing all ingredients.
The experience of the Agency has been detecting unlabeled ingredients in herbal products. This has proved too costly both in terms of money and time. A number of these have revealed potentially dangerous components (antidepressants, tranquilisers and sedative combinations) and illegal ingredients (steroids in creams whose regular use could cause skin cancer) while some have bogus claims e.g. cure for all ailments without scientific back up, some contain ingredients that have recently been associated with hepatic/liver injury (St. John’s Wort). Consumers must therefore begin to examine closely what they permit for their use.
In the continuing effort to protect the health of the consuming public especially in Nigeria, NAFDAC has decided to classify those herbal medicines that claim therapeutic use and those which contain chemically defined actives combined with plant constituents to be “drugs”.
The evaluation of medicinal plant products is therefore done from a biological point of view because of their therapeutic claims.
All or some of the under listed tests are usually carried out in the laboratory, depending on the source of sample and reason for analysis. Dossiers on the products are also reviewed to assess GMP and long-term use, etc. The ultimate aim is to protect the consumer from harm, especially long-term effects.
TESTS
Examination for foreign matter (Organoleptic tests)
Extractable matter - to determine their solubility
Water and volatile matter especially herbal cosmetics to know their stability. Those with high essential oil content are tested for water content.
Stability tests are reviewed to establish shelf life.
Volatile oils (“essence” of the herb/active principle)
Tannins (used as astringent) is sometimes determined
Moisture content/and or hydiophobicity Heavy metals, especially mercury, lead arsenic etc.
Must comply with WHO requirement for pesticide residues depending on the nature of the plant.
Microbial Load or sterility test. TLC to determine impurities, identify known active principles when reference standards can be sourced.
Safety evaluation (LD or Acute Toxicity Test)
Disintegration tests.
In conclusion, even though a lot of herbal products are of good quality, there is the need to exercise caution in taking, advertising or advising usage of herbal medicines, as they can cause considerable damage especially to the liver. Consumers are advised to confirm product registration with NAFDAC before patronizing such .products. If in doubt consult your healthcare practitioner.
Courtesy NAFDAC
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