Article by Brent Murphy

Are you getting what you paid for?

Will the product you’re using do what it claims? Will you lose those 10 kilos, feel great, have balanced hormones and an improved sex drive? Does the product contain exactly what the label claims, at the stated potencies and concentrations?

You see, the natural medicines industry is a self-regulated one, much like the food industry. It is an industry based largely on trust – consumers trust that they are getting what the label claims, and that the product will perform accordingly. Worldwide, including South Africa, the laws governing complementary medicines are relaxed.

Furthermore, anybody can bring a natural medicine to market; natural medicine companies are not required to have a doctor, pharmacist, homeopath, food technologist or even an allied health professional on board. Most companies do have them, but some don’t. Occasionally, the result is that the product may not contain what the label claims, due to a lack of knowledge of some critical component of production – such as cold storage, or the correct choice of plant extracts.

Most companies have sales and marketing directors, whose job it is to sell the product. Sometimes they push the boundaries. Claims of effectiveness are sometimes made that aren’t possible at the fractional doses contained in the product. Occasionally opposition companies compete to bring out the cheapest possible product, and sometimes raw material quality and adequate dosage recommendations suffer as a result – whereas packaging quality improves to give the appearance of quality.

In fairness, I should point out that these concerns are the exception to the rule. For the most part, the consumer has little to worry about. Most natural medicines contain what the label states and don’t make over-the-top health claims. In this article I’ll discuss ways of telling the good from the bad, and what makes a quality product.

So then, what are the possible problems, and how can you avoid them?

Active ingredient discrepancies

Example 1: Probiotics
A study performed on nine South African probiotic products last year, found that only three contained the strain and quantity of bacteria claimed on the label.1 The balance of six either had no live bacteria, or contained a different strain of bacteria from that claimed on the label.

How is this possible? Probiotics are good bacteria, responsible for a healthy gut and immune system. With the exception of Lactobacillus sporogenes, all probiotics rapidly decay at room temperature, or in acid or humid conditions. L. sporogenes is an exception because it is not actually a live bacteria, but a dormant spore form that is stable at higher temperatures, only coming to life in stomach acid. All live probiotics should ideally be stored in the fridge.

However, these probiotics can be stored at room temperature if the manufacturer puts an excess of 10 - 100 times the quantity of the label-claimed bacteria (termed an overage) into the product, and if stability can be proved in tests performed on the product. This is so if after a defined time period, say 18 months and heat-related decay, not less than the label-claimed quantity of bacteria are still present in the product. In such cases the manufacturer should be able to back up room temperature claims with evidence to show that the product still contains the claimed quantity of live bacteria, after being stored for prolonged periods at room temperature.

Advice for the consumer
With the exception of L. sporogenes, store your probiotics in the fridge. You will always be guaranteed a more effective product if you do this. If the manufacturer claims that the product does not have to be stored in the fridge, contact them and ask to see stability data documentation that proves this claim. A refusal or inability to provide this should sound warning bells.

Example 2: SAMe
Two years ago The Star newspaper reported on a South African product claiming to contain SAMe (s-adenosyl-methionine). In reality it contained none.2 SAMe is an amino acid that reduces a heart toxin called homocysteine, and helps with depression. Instead of SAMe, ordinary methionine was found in the product – an ingredient 10 times cheaper than SAMe. Methionine has virtually no antidepressant effect and can actually raise homocysteine levels. The manufacturer changed the label, no longer claiming to contain SAMe, only after this information became known, although the label still claims to contain ‘formula S07 SAMe’.

Advice to the consumer
If the price of a product is much less than that of other products containing the same ingredient, be circumspect. You get what you pay for. If the price is too good to be true, maybe it is. Read the label carefully. If the ingredient composition is hidden in pseudo-technical mumbo jumbo terms, be careful. Contact the supplier and ask for an exact breakdown of what the product contains.

Example 3: Gingko biloba, echinacea and others
A recent study published in the Archives of Internal Medicine analysed 59 echinacea preparations and found that about half did not contain the species listed on the label.3

In January 2003 Consumer Lab in the USA tested nine Ginkgo biloba products. Seven of the nine ginkgo products were found to lack adequate levels of one or more important compounds expected of clinically effective ginkgo.4 Six products had less than one-fifth of the expected amount of bilobalide, a type of terpene lactone that may be particularly important to ginkgo's effectiveness. Consumer Lab tested about 75 other classes of vitamins, minerals and herbals ranging from echinacea and ginseng to vitamin B, etc. About 50 classes did not contain what the label claimed. Full details on all classes can be viewed at:www.consumerlab.com

Although these are American products, it would be naïve to think that this problem does not occur in South Africa. The reasons for this problem are:

Tablets or capsules made with milled dried herbs instead of herb extracts.
A milled powdered herb is about 5 - 10 times less concentrated than an extract. A plant extract is manufactured by removing the fibrous inactive material from the plant, leaving a concentration of active components. Therefore 500 mg of a 5:1 St John’s wort extract contains five times more active components than 500 mg of St John’s wort powder. Extracts are far superior to milled powders, albeit more expensive. The best type of extract is a standardised extract. A standardised extract means that tests have been performed on the extract to verify the concentration of its active components. Another problem with milled powered herbs is oxidation. Oxidation destroys what little actives are in the product. Clinical studies showing heath benefits are always performed on extracts. If you are expecting similar benefits from non-extract milled powder products, you would have to take 5 - 10 times the quantity. Labels are often ambiguous as to whether the product is made from an extract or not.

Advice to the consumer
Check whether the label states extract, or preferably standardised extract. Read carefully to ensure that it’s not a 10% extract / 90% milled powder blend. Since milled dried herb powder is much cheaper than an extract, sometimes only a token quantity of an extract is included, just to be able to claim that the product contains an extract. If in doubt, phone the manufacturer and ask them to fax you the one-page certificate of analysis on raw materials used. This certificate will show whether the materials are extracts or not. Ask to see a copy of the original certificate, not one transcribed onto the manufacturer’s own letterhead. Good companies have no problem supplying this information.

Also ensure that the product you are purchasing does not include the weight of the capsule shell as part of the content mass. Some products mention on the front packaging in bold letters ‘500 mg capsule’, implying that 500 mg of raw materials are contained in the capsule. However, careful reading of the small print on the rear of the label shows that each capsule contains much less than 500 mg, and that part of the ‘500 mg capsule’ mass is in fact made up of the empty shell. This mass can be quite large in the case of softgel capsules, which are thick and heavy.

Sometimes information is absent or ambiguous. This is often the case with minerals, where the form of the mineral is not disclosed. Iron from iron fumerate is much less effective, less absorbable and has more constipating side-effects than iron from iron succinate. Also be aware that some companies show the total mass of the mineral salt, for example ’30 mg zinc gluconate’, rather than the elemental amount, because it sounds more. Since only 13% of zinc gluconate is actually zinc, this 30 mg actually supplies only 4 mg of elemental zinc. Ideally the label should show the total mass of the mineral salt (so that you can know which form the mineral is in, e.g. a fumerate, picolinate, amino-acid chelate (chelates are regarded as the best form)). The label should also disclose the amount of elemental mineral that this salt supplies (so you can determine the amount of the mineral you are actually getting). An example is ‘each capsule contains 20 mg iron (from 108 mg iron succinate)’.

Health claims not achievable at doses contained in the product.
A common marketing trick in the natural products industry is to claim a therapeutic benefit at doses much lower than those shown to be effective in clinical trails. A typical example is the weight loss ingredient pyruvate, where clinical trials show5 weight loss only at dosages of 6 - 20 g per day. Yet many manufacturers will put 100 times less than this into a product and claim the same weight loss benefit. At a glance, the clinical information referred to in advertising may appear to show that the product will work. However, upon careful reading of these trials, doses needed to show benefit usually are far greater than those found in the product. This is particularly true in the weight loss industry.

Advice to the consumer
Ask the manufacturer for proof of claims made. This proof should be from clinical journals, not the popular press. Read these carefully and take note of effective dosages and compare these with the dose recommended by the manufacturer.

You could also make use of informative websites. My favourite ones are:
www.supplementwatch.com
www.mothernature.com/library

Alternatively, feel free to contact me by e-mail: pharmacist@finepharmaceuticals.com and I’ll try to help you.

Remember, you are the consumer and the patient. Natural medicines can help you live longer, more healthily and with more energy. But you have the right and responsibility to make the correct decisions. Your health is in your hands.

References
1. Elliot E, Teversham K. An evaluation of nine probiotics available in South Africa, August 2003. SAMJ 2004; 94: 121-124.
2. Questions over wonder drug content. The Star, 18 December 2001.
3. Gilroy CM, Steiner JF, Byers T, et al. Echinacea and truth in labelling. Arch Intern Med 2003;163: 699-704.
4. www.consumerlab.com
5. Stanko RT, Reynolds HR, Hoyson R, et al. Pyruvate supplementation of a low-fat diet: effects on body composition. Am J Clin Nutr 1994; 59: 423-427.