No Approved Therapeutic Claims

Categories: Disease Food Health Medicinal Plants

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Herbal supplements have now become popular alternatives for the health needs of many people, as new safety regulations have been implemented. However, some still ask, are they good for you? Well, that would depend on the herb, your current health and your medical history. Herbal medications sometimes have active ingredients that can affect how your body functions, just as over-the-counter and prescription drugs do. These medications could be particularly risky for certain individuals, and many herbal product labels are often vague, confusing and of little help when it comes to making a wise selection.

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It is advisable to remember that if you're considering herbal supplements or other dietary products, educate yourself about any medications you intend to use before purchasing them, and talk to your doctor about any herbal products you're considering taking.

Are Most Herbal Treatments Safe?

Until recently, government regulation and consumer protection were quite limited for dietary supplements. However, new rules noted by the Federal Food, Drug, and Cosmetic Act give the Food and Drug Administration (FDA), the federal agency responsible for regulating the safety of food and drug products, the authority to oversee the production of local and imported dietary supplements, including herbal treatments.

Dietary supplements don't need to go through the rigorous review process that new drugs must undergo before being "approved" by the FDA.

However, the new regulations aim to enhance consumer safety by requiring supplement manufacturers to follow certain manufacturing practices and ensure that supplements contain what their labels claim, and are free of contaminants.

The FDA is responsible for monitoring the safety of herbal treatments after they're on the market and enforce punitive action against violators that sell unsafe supplements. These new regulations will be phased in over a three-year period so that by June, 2010, all supplement manufacturers should meet these requirements.

"No approved Therapeutic Claims": What It Truly Means

The proliferation of food and herbal supplements, which are being advertised and passed on as effective cure-all products, despite the fact that these have no established therapeutic effects, is a major problem for regulatory health agencies. To the common consumer, the phrase "No Approved Therapeutic Claims", would generally mean that a supplement has not yet been determined by the FDA to be as safe and effective as advertised. It could also mean that no studies and long-term research have yet been done to determine the efficacy of the pill, or herb in actually treating anything. This phrase usually serves as a disclaimer of sorts.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was passed by US Congress to ensure consumers' rights to access safe and effective dietary supplements. This law gave the FDA the mandate to strictly monitor this sector, and ensure the products were safe and made in a consistent manner. The FDA also passed rules to require "Adverse Event Reporting", which requires herbal medicine producers to track safety data, as well as ensure good manufacturing practices. This also means that the herbal products must be made to standardized quality to ensure that consumers are getting good-quality and safe products.

The Food and Drug Administration (FDA) warns the public to be cautious in taking foods or dietary supplements for curing purposes as it has no approved therapeutic effects. This applies to testimonials given by certain individuals with or without the consent of food manufacturers, importers or distributors promoting or advertising said product. The FDA labeling regulation under Bereau Circular No. 02 s. 1999 requires the declaration of the statement “NO APPROVED THERAPEUTIC CLAIMS” on the label of all food and dietary supplement as a means to inform the consumers that food and dietary supplement has no approved curative effects. Food and dietary supplement could be taken to support nutritional needs of the body. However it has not been given approval for any therapeutic effects which could only be granted to drugs as proven by clinical studies.

Promotional oradvertising materials containing testimonials and anecdotal information on food and dietary supplement associated with healing or curing diseases are not allowed. The FDA further advises public not to believe any curative claims on food anddietary supplement and not to stop prescribed medications in favor of food anddietary supplement unless otherwise advice by a physician. The Fda issues certificate of product registration to food and dietary supplementfound to be compliant to regulatory requirements. Registration status of any food and dietary supplement can be checked at FDA landline number 842-5606.

Herbal and dietary supplements represent a growing billion-dollar business in the U.S.,and worldwide. The herbal phenomenon is part of a larger "alternative medicine" movement, which seeks to utilize both traditional and New Age methods of disease prevention and treatment. There is no doubt that the active ingredients in some herbal mixtures show great promise in the prevention and treatment of a wide range of diseases and ailments, as shown by a large body of scientific data that has been collected and published in reputable medical and scientific journals. The use of herbal and dietary supplements, however, poses major health risks, and these risks are largely due to the varying nature of herbal preparations, as well as the lack of consumer protection generally given to prescription drugs by the Food and Drug Administration (FDA), because herbal and dietary supplements are not officially classified as drugs.

Herbal medicines and dietary supplements are generally processed plant ingredients, solvent extracts, or essential oils of plants. All plants, including herbs, naturally synthesize a lot of complex chemical compounds as part of their metabolic activities. Many of these extracts are not dirPDFectly related to the plant's energy production but are toxins synthesized by the plant in order to ward off other plants, herbivores, and plant parasites. Thus, all plant materials contain large numbers of chemical compounds, some of which may have a desired physiological effect and others which may have no effect whatever ,or may contain a number of harmful effects when consumed by individuals. Many herbs in fact, contain compounds that act differently from the principal active ingredient

What Exactly Does "No approved Therapeutic Claims" Mean

Lately there have been a lot of herbal supplements sold, which claim to aid vital organs from harm caused by excesses of lifestyle characterized by overindulgence in eating, drinking and other unsafe practices and immoderate diversions. The proliferation of food and herbal supplements, which are being advertised and passed on as effective cure-all products, despite the fact that these food and herbal supplements have no established therapeutic effects, is a major headache for regulatory agencies and health watchdogs. To the common consumer, the phrase would generally mean that a supplement has not yet been determined by the FDA to be as proven and effective as advertised. It could also mean that no studies and long-term research have yet been done to determine the efficacy of the pill, or herb in actually treating anything.

This phrase usually serves as a disclaimer of sorts. The Dietary Supplement Health and Education Act of 1994 (DSHEA) was passed by unanimously by the US Congress to ensure consumers' rights to access safe and effective dietary supplements. This law gave the FDA the mandate to allow this access, and ensure the products were safe and made in a consistent manner. The FDA last year, finally passed rules to require "Adverse Event Reporting", which requires supplement companies to track safety data, as well as ensure good manufacturing practices. This means that supplements must be made to standardized quality to ensure that consumers are getting consistent products.

MANILA, Philippines - Comfrey, kargasok tea, noni juice, mahogany seeds. Tell me which ones you remember and I can tell what your age range is. These were the natural medicine fads that came, conquered, and then faded away, usually after the government came out with a study warning about the dangers of using them, or an official notice that these so-called cures have no proven medicinal effect. But these were not short-lived fads, with some of them lingering on for years after they declined in popularity. I still see some of these former celebrity plants being sold by vendors, complete with outrageous claims. Not only that, they?ve been joined by dozens of other products that Filipinos call, generically, ?herbal? (er-bal), even if many of them are not derived from plants. Officially, the Bureau of Food and Drugs (BFAD) considers these products ?food supplements? rather than drugs (or medicines). If they do go through BFAD review, they are not evaluated for effectiveness.

Neither are the safety evaluations too stringent. The only requirement BFAD has is that ?no therapeutic claims? are made by distributors, but this rule is observed more in the breach. Often enough, the products are sold without any medicinal claims; sometimes they?ll even have a sticker saying ?No Therapeutic Claims,? but promotional materials will often name all kinds of sicknesses for which the supplement is supposedly effective. Sometimes, too, the promotional literature will contain all kinds of testimonies, and so-called scientific explanations for the products? ?effectiveness.? I?ll never forget one explanation on why shark cartilage (now there?s an example of a non-herbal ?herbal? cure) prevents cancer: sharks don?t get cancer. Sure. Many people are unaware that an ?Approved by BFAD? label doesn?t mean the product is medicinal. Being sold in a drugstore doesn?t make the product a medication either, as even chocolate bars, chewing gum and groceries are sold in pharmacies these days.

Be extra careful as well about products sold in Chinese drugstores. Get ready for a shock: while ?western? drugstores like Mercury are subject to inspections and strict BFAD rules, the Chinese drugstores are exempt. The reason? They?re considered cultural institutions, and the products they sell are presumably cultural products exempt from BFAD scrutiny. Yet there is a large and growing market for these products. While ?western? medicines are identified mainly as products for the sick, food supplements or ?natural? medicines are peddled with all kinds of claims that appeal to the healthy and not so healthy, as well as those who are suffering from ailments, usually chronic ones. Food supplements have a particular appeal because of fears that people have of western medicine, often seen as having side effects. Unfortunately, people tend to presume that ?natural? means totally safe, and this just isn?t the case. There?s also something very disturbing about the more popular faddish food supplements: they?re imported. We tend to go for these because of our colonial mentality, and are all too willing to pay through our nose for these products.

A few years back, I witnessed rural middle-income families spending half of their monthly income to buy Herbalife, which was a US-based chain whose products are sold house to house much like Tupperware. In more recent times, people would spend almost a thousand pesos for a bottle of Garcinia juice. You know what Garcinia is? Mangosteen. We neglect our own resources and folk knowledge in favor of imported, unproven fads. I know it?s a human inclination: stuff from remote places, with strange names like Kargasok, seem so much more effective than plain old luya (ginger) or damong maria. It hasn?t helped that our scientists have moved so slowly on medicinal plants. The Department of Health only approves of 10 local plants. Thirty years ago, freshly graduated from college, I worked as a researcher on medicinal plants. In one year of moving around the country, I was able to list more than a thousand plants being used by local herbalists, and over 70 which were listed in other countries? official lists of approved medicines.

These days it almost seems like we have a schizophrenic government when it comes to medicinal plants (okay, okay, so it?s schizo about many other aspects of governance as well). The Department of Health tends to be very cautious and reluctant to endorse medicinal plants, even as it gives a BFAD seal of approval, without explaining that it does so only by classifying natural products as ?food." The Department of Education actually likes medicinal plants, but mainly as gardening projects for public schools. Almost nothing is being done to educate our children about the scientific basis for medicinal plants, or traditional medicine in general.

These days, the Department of Tourism has jumped into the act, promoting ?indigenous medicine? as an exotic come-on for tourists: come get our traditional massage, come use our medicinal plants for aromatherapy. Meanwhile, we neglect research on medicinal plants while a whole underground economy flourishes, selling American food supplements. Some of these products can be effective, but again, too little is being done to educate the public on what works and what doesn?t. Even more importantly, we shouldn?t forget that the best preventive and curative health measures still aren?t western pills, or all these ?herbals?: it?s still good nutrition, lots of exercise and a healthy outlook on life.

Health supplement products have been sprouting almost everywhere with their frequent advertisements especially on the radios with testimonials that their products are truly effective and can cure diseases which never thought of.

The health supplement companies have been using the "no approved therapeutic claims" tag for their products on their advertisements, but unfortunately, even I don't know the meaning of it unlike the government's warning against the use of cigarettes which is easy to understand.

Though it is short, not all of us know what it means. Does it mean that it's therapeutic claims are not approved? Who approves it? What are therapeutic claims?

I applauded the move of then Department of Health Secretary Esperanza Cabral when she issued an administrative order to change it into: "Important notice: The product is not medicine and is not to be used for treating diseases." or in Filipino "Mahalagang paalaala: Ang (name of product) ay hindi dapat gamiting panggamot sa anumang uri ng sakit." which is more understandable to the greater public. After that, health supplement companies were raged by the order and immediately lashed out Cabral for her move. For them, it was like committing suicide on their own products. It was just to make the public know that what they are selling is not a medicine and only a supplement. Their consumers have been disillusioned that once you intake and maintain the health supplement, it can already substitute your very expensive medicine. That's already deception.

Although there have already been products that adhered to the order, there are still those especially online who continue the practice to misinform more and more people. I hope the Department of Health can also extend their campaign on these health supplement products that are being advertised online especially on Facebook where you are tagged by a photo of that health supplement product.

Then there's also these artists who promote the product that they even don't know just for the talent fee. Now, with an "artista" touch on the health supplement product, more and more people will be enticed to buy it. The more these companies misinform people, the more money they make. I hope they have some conscience left at least a bit. I know a certain person who was taking a health supplement product only to find out that it was not helping after all and instead, it complicated his health problem. He didn't knew that he was taking in a substance from that product that he should have been avoiding. Now, he has already recovered and I hope the number of people being deceived by these would lessen and eventually to nil.

Let's always remember that these are just supplements, not medicines. Don't be fooled!