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PHA 2nd Summit on Supplements "Heart Supplements: The Facts and Fallacies"
Bayview Hotel, Manila February 26, 2010 HON. DR. ESPERANZA I. CABRAL Secretary, Department of Health Thank you and good morning, everybody. I appreciate the respite from birth controls and condoms even for just a few minutes. After this I have to run again and face other issues, but thank you and I am happy to be here and participating in the 2nd Summit on Supplements in particular on the topic Heart Supplements: Fact or Fallacy. I noticed that in the program two speakers are here to talk on the regulatory sanctions of government - both the Department of Health and the Food and Drug Administration. It's going to be a little redundant in as much as the Food and Drug Administration is actually an attached agency of the Department of Health. You just have to bear with the both of us if there are things that we are going to repeat. From capsules that stop the onset of a cold to pills that boost male virility to teas that can "cure" every kind of imaginable illness, countless numbers of these products have flooded the Philippine market and the collective consciousness of the Filipino public through hours and hours of advertisements in all forms of mass media. Conservative estimates say that the business of selling food supplements has grown into a multi billion-peso industry locally, fueled by aggressive marketing and the patronage of a populace eager to find solutions to a myriad of health problems that are not or cannot be completely addressed by mainstream health systems. Particularly significant for us is the fact that many of these food supplements are not only claimed to have beneficial effects on the cardiovascular system, but even more importantly the fact that there are hidden side effects of many food supplements on the cardiovascular system, many of which are, in fact, adverse. This sudden explosion in the popularity of food supplements in the Philippines raises many issues, including questions on quality and ethics. Certainly, the magnitude of this issue has made it a major public health concern that must be addressed by all stakeholders in the health sector. Earlier Bong gave us a definition of what a food supplement is, but that was a very old definition and there is actually a newer one contained in Republic Act 9711 or the Food and Drug Administration Law, where it says that a food or dietary supplement "shall mean a processed product intended to supplement the diet that bears or contains one or more of the following ingredients: vitamins, mineral, herb, or other botanical, amino acid, and dietary substance to increase the total daily intake in amounts conforming to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements. It usually is in the form of capsules, tablets, liquids, gels, powders just like drugs, but are not represented for use as a conventional food or as an item of a meal or diet or as a replacement for drugs and medicines". The definition basically covers everything that we need to know about what a food supplement is, and from it are derived many of the provisions of the Food and Drug Act related to the use and promotion of this particular item. The Food and Agriculture Organization of the United Nations states that, except for protein, the typical Filipino diet is grossly inadequate in energy and other nutrients, making micronutrient deficiency a major health issue among our people. This perhaps represents the opportunity for the industry to be a positive contributing force to the over-all health situation in the country. However that is not the case, in fact, it is quite the opposite. One problem that we have, however, is I think we fall into the trap of demanding benefits from food supplements other than what they should have by definition, and we all know that the definition of supplement is that it is intended to supplement an inadequacy in the diet of a person. But of course, many of the manufacturers of these food supplements claim or would like to claim every sort of benefit attached to their product so that they can be bought. And many people would like to believe these claims because they don't like to take conventional medicines or they feel that it is safer because of this myth that if it is natural it has no side effects. So the other side of the food supplements industry is what conforms more to reality. It is quite clear from the provisions that they are not meant to be taken as drug replacements. Being classified as such, these products do not have to pass through the very strict battery of scientific and clinical tests required of medicines before they can be given approval by the FDA. Nor is there extensive database that covers all information on these supplements, even as there exists for medicines or drugs. This liberality given to dietary supplements has unfortunately been exploited in the furtherance of profit. We all know that food supplements cannot cure disease; they are not meant to be so. We should not demand scientific evidence that they do so. If we demand scientific evidence that they do so, we are in fact saying that this is a drug. It is plain to say that many companies have taken the track of passing off their products as cures for anything from allergies to cancer. This is patently illegal, considering the definition of the product that they sell and that the law explicitly prohibits the promotion of these products for something that they do not do. Our laws provide penalties for those who "disseminate or cause the dissemination of false, deceptive or misleading advertisement, promotion or marketing materials for the purpose of inducing directly or indirectly, the purchase of a particular food or dietary supplement". Yes, all of these products have disclaimers that they are not meant to replace medicines but this safeguard is rendered impotent by suggestive, if not outright false advertisement by the manufacturers. Take for example, one-minute infomercial where famous celebrities extol the curative effects of a particular supplement on their ailment. Then after this thirty seconds of whatever it is they're playing, the one-second disclaimer of "No Approved Therapeutic Effects". It doesn't take a rocket scientist to figure out which of these two messages will stick in the mind of the viewer. This issue becomes even more pressing considering that the misuse of these supplements will entail huge economic and social costs for us. It is estimated that the total drug market is P150 billion a year yet it is also estimated that half of this money is wasted on products that have no effect on improving the health of anyone. It is therefore logical to surmise that a substantial part of this P75 billion which constitutes about 1 percent of our gross domestic product has been spent on supplements that are being used as drug substitutes. Many of these companies flaunt scientific and medical research that supposedly back up their claims, but many of these drugs and many of these studies are false. As far as we are concerned, therefore, these studies mean nothing to release the manufacturers from the responsibility of not marketing their products as curative or therapeutic. An even grimmer prospect is the potentially adverse effects these supplements have on people. That is why the Department of Health, through the FDA has taken steps to strengthen regulatory mechanisms related to these food supplements. Therefore, the Food and Drug Administration is going to be stricter about the registration of food supplements and about the labeling of these food supplements. The core of this activity is the new rule on the use of the disclaimer "No Therapeutic Claims". We all understand what it says that there can be no therapeutic claims attributable to the product. Unfortunately, not everybody in the Philippines has a medical background, not everybody can speak good English even, so that we are now going to replace this one-liner with a Filipino translation that will be included in all forms of advertising, promotion and sponsorship activities and materials.
To also prevent the circumvention of this rule by relegating these disclaimers to small, unreadable print, we have added specific rules on the size of the disclaimer as well as on its emphasis in the packaging of the products. It will have to be contained in the primary labels in the package as well as in all advertisements, promotions, and sponsorships that they have. We are not against the supplements industry per se, and we recognize that they may actually have a legitimate niche in the health sector, in support of medicines and sound physicians' advice. The flaws in the industry however, seem difficult to ignore and it is our job as guardians of the public's health to ensure that these flaws are corrected and that adherence to our regulatory mechanisms are strictly implemented. In this particular concern we need the help of everybody, the members of the Philippine Heart Association, the advertising industry, and the media in order for us to provide the proper information to our people so that they can use their money for better things. Thank you very much. |
