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Pinoy Kasi
Herbal medicine

By Michael Tan
Philippine Daily Inquirer
First Posted 05:55:00 05/26/2010

Filed Under: Medicines, Advertising, Consumer Issues

Only in the Philippines have I seen signs on empty plots of land that declare: ?This lot is not for sale.?

Those signs have to be put up because there are con artists who are able to sell pieces of land they don?t own. To some extent, there?s gullibility on the part of the buyers, who don?t check land titles but then there?s also the problem of a land registration system that?s riddled with inefficiency as well as corruption, making it easy for crooks to operate.

I couldn?t help seeing the parallels between declaring a lot to be ?not for sale? and a Department of Health administrative order signed in March by Health Secretary Esperanza Cabral that requires food and dietary supplements, including many medicinal plant preparations or herbal medicine, to be labeled in Filipino: ?Mahalagang Paalala: Ang (name of the product) ay hindi gamot at hindi dapat gamiting panggamot sa anumang uri ng sakit.? (Important Notice: This product is not medicinal and should not be used for any kind of illness.)

That message is also now required on all advertising materials for the supplements with detailed specifications. On print materials the message must be ?. . . at least 1/3 of the size of the largest letter/logo and prominently (all in capital and bold letters) printed above of every advertisement, promotional activity or any material used. Only the fonts Arial or Tahoma shall be used. . .?

Audio advertisements require the message to be ?clearly and audibly voiced over, without being cut off, in the last line of the advertisement or promotion regardless of its duration.?

No therapeutic claims

If the administrative order tries to plug all loopholes, it?s because there have been so many abuses of the legal provisions on ?food supplements.? For several years now, following a ?back to nature? fad, we?ve been bombarded with advertisements extolling the virtues of these products with claims of cures and preventive and curative powers for all kinds of illnesses. The advertisements always emphasize that they?re registered with the Bureau of Food and Drugs (the old name for the Food and Drug Administration) and people end up thinking the product is an approved medicine.

Like our land registration system, which has many gray areas around the legal status of property, our system for registering food and drugs is not always clear. Look around your own home and you will find many products registered with the government, but look closely and you will see some differences in the registration system. A medicine is registered as a drug, so the registration number has the prefix ?D?. Another category, much broader in its scope, is that of food and dietary supplements, which have a prefix ?F?.

A food/dietary supplement is defined more clearly now in the DoH?s administrative order as ?a processed food product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, herb, or other botanical, amino acid, and dietary substance. . .? The definition is much longer but the other relevant passage is the last part: ?It usually is in the form of capsules, tablets, liquids, gels, powders or pills and not represented for use as a conventional food or as the sole item of a meal or diet or replacement of drugs and medicines.?

I thought of the lines in older Superman films: ?Is it a bird? Is it a. . . ? That?s the same problem with these products: they look like medicines, sometimes taste like medicine, but are not considered, legally at least, to be medicine. Note how this category includes vitamins and minerals.

But the differentiation from drugs or medicines is important. Pharmaceuticals are registered only after a long process that proves the safety and efficacy of the product, including submission of the results of extensive clinical trials. Even then, the drug regulatory authorities require monitoring of the use of the medicines because as the drug gets to be used by more people, and over a longer time than the clinical trials, other problems and limitations of the drug will emerge.

With food and dietary supplements, the products are mainly evaluated for safety, and safety here is more about hygienic preparation. That is why originally, the government only required labels that read, ?No Approved Therapeutic Claims,? a way of saying that the drug regulatory authorities are not endorsing the product for any medicinal purpose.

The producers and distributors of these food supplements complied, but many also twisted the rules. I?ve lost count of the advertisements I?ve heard on radio rattling a long list of claims for one of these products?high blood pressure, diabetes, cancer?followed by a quick, ?No Approved Therapeutic Claims.?

The United States also had similar problems and the dietary supplements produced there will make general statements about the product?s health benefits but include a box: ?This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.?

?Binisayang tambal?

It used to be much simpler, with just two parallel health care systems: a ?Western? one with pharmaceutical preparations mass produced in factories and highly regulated by the government, and a ?traditional? Filipino one with medicinal plants sold fresh or as concoctions in markets and in church courtyards, often with no packaging and therefore no therapeutic claims. People used them according to folklore, information passed on across generations, or through the neighborhood. No ?food? or ?dietary supplements? categories yet, although people themselves made the distinctions: in southern Philippines the traditional medicines are called ?Binisayang tambal? (Visayan medicine).

Today, with globalization and the Filipino diaspora, we have, on top of our own preparations like pito-pito and ?pampabalik ng regla? (menstrual regulators), all kinds of products from every corner of the world: European homeopathic preparations, Gingko biloba and Echinacea from the US, Ayurvedic teas from India, ginseng and deer penis from China. (Which reminds me that the DoH?s definition of food supplements only mentions botanicals, which means plant-based products, and somehow forgets animal-derived products like those Chinese aphrodisiacs.)

?This is not a medicine? labels are useful warnings, but we also need more information on the many ?alternative? medicines that are being imported by natural-food stores, or that are coming in through balikbayan boxes, all without going through the Bureau of Food and Drugs.

I check with the websites of the US Food and Drug Administration and the Mayo Clinic for more information. Sadly, we know much less about local traditional medicines, with the DoH having endorsed only 10 medicinal plants. There are many other traditional preparations still being used out there, and for now, the official stand will have to be: they are not medicines.



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