Showing posts with label the FDA. Show all posts
Showing posts with label the FDA. Show all posts

Thursday, November 27, 2014

Dietary Supplements-The Damocles Sword hanging over users!

Man's eternal search for "pink health" can take him to any where at any risks but this is precisely the prime motivating factor for many unscrupulous industry players to market a variety of products with tall but unsubstantiated health claims on bringing about dramatic improvements, general or specific, in the health of the unsuspecting buyers. The government has the onerous responsibility to check this menace through regulatory controls which need to be science based. In many countries these peddlers of so called "well being" products have a free run because either there is no law to regulate them or the existing laws are ambivalent giving sufficient leeway to the lawyer community to argue their cases out in the court if at all they are caught! Why should any normal person take any supplements at all? What do the citizens understand when products with tall health claims are dangled before them? 

According to classical definition "dietary supplements are intended to provide nutrients that may other wise not be consumed". It is very clear that these supplements are not for those whose diet is balanced in terms of all nutrients required by human body and there fore they need to be taken only after consulting a physician regarding any deficiency symptoms detected by him. Unfortunately physicians are never brought into focus when consumers unilaterally decide to take them because of high pressure promotions and tall claims made by the industry. Look at  some of the most patronized supplements in the market to realize the dimension of the problem. Supplements are offered in the form of pills, capsules, powders, drinks, energy bars, food adjuncts etc containing a variety of health "supporting" materials like vitamins, minerals, fatty acids, essential amino acids, herbals and botanicals, enzymes, antioxidants, fish oils, probiotics etc. The multibillion dollar industry spanning the entire world market a staggering 55,000 and odd products under the supplement category and in a country like the US more than half the population consume one or more supplements almost every day! 

A million dollar question is what the hell the governments in many countries are doing except closing their eyes to the existence of this roaring industry making money left, right and the center with practically no conscience for selling products, most people do not need at all!.  According some respectable experts 90% of the health claims made by peddlers of such products are incorrect and unsubstantiated and to add insult to injury more than 30% of such products do contain unlisted steroids. USA is an astonishing country where people have unlimited liberty to do any thing with least control over them under the pretext that it is one of the oldest democracies in the world. In this "great" country any one can sell a supplement without permission from the safety enforcement authorities who will have to look at these products only when some injury is caused and reported! In contrast in Europe food supplements must be demonstrated to be safe in dosage and purity as being suggested by the manufacturer before marketing them. 

It is mind boggling that the Americans spend an estimated $32 billion on dietary supplements every year, attracted by unproven claims that various pills and powders will help them lose weight, build muscle and fight off everything from colds to chronic illnesses. Alarm bells are now being sounded about the magnitude of liver damage cases being reported across that country which are linked to supplements though many believe that a majority of supplements are generally safe. In recent years, critics of the industry have called for measures that would force companies to prove that their products are safe, genuine and made in accordance with strict manufacturing standards before they reach the market. An antiquated federal law enacted in 1994, the Dietary Supplement Health and Education Act, "prevents" the Food and Drug Administration from approving or evaluating most supplements before they are sold. Usually the agency must wait until consumers are harmed before officials can remove products from stores. Because the supplement industry operates on the honor system, studies show, the market has been flooded with products that are adulterated, mislabeled or packaged in dosages that have not been studied for safety.

One encouraging feature of the supplement landscape in the US is that most of the products implicated in liver injuries were bodybuilding supplements spiked with unlisted steroids, and herbal pills and powders promising to increase energy and help consumers lose weight. Probably those peddling them are criminals who see a business opportunity to spike some products and sell them as dietary supplements. Probably it may be the fringe of the industry deflecting any wholesale blame of the entire industry. Many of the popular supplements like vitamins, minerals, probiotics and fish oil had not been linked to any definite patterns of adverse effects and there fore they have a case for continuing their business with out any restriction by government. the flip side of this enigma is that the FDA is alarmed by the fact that 70 percent of dietary supplement companies are not following basic quality control standards that would help prevent adulteration of their products and the likely consequences there of. Of the 55,000 supplements that are sold in the United States, only 170 or about 0.3 percent, have been studied closely enough to determine their common side effects. 

Common sense says that only when a product is  regulated by a government agency with appropriate technical competence, its benefits and side effects can be fully known based on which an informed decision can be taken by the consumer whether to take it or not. After all every day life is a balance of "risks and benefits" and it is the duty of any responsible government to make available such information to the citizen in a transparent manner. It is some thing like the "injurious" warning mandated to be printed on cigarette packs to warn the consumer about the dangers of smoking. Similarly once consumers of dietary supplements know about the consequences of consuming it, probably that may serve as a deterrent against buying the same which after all does not restrict his freedom of buying such products, if he still wants to go ahead.  

In India the situation is more complicated because the safety monitoring as being claimed by the entrusted agency is all but a sham with the food products themselves not being assessed for their safety let alone the dietary supplements! There are innumerable instances of many food products, some of them made by multinational companies claiming that they boost intelligence, make the children tall and strong, restores energy in few seconds after consuming, etc. Complicating the issue further there are an array of products being offered by the organized industry based on traditional Ayurveda system which can be considered as supplements and there are no regulations which control these products. It is time that the government of India wakes up to streamline the food products and food supplements industry through effective standardization and safety parameters that can prevent food related damage to the health of the citizens. .

V.H.POTTY
http://vhpotty.blogspot.com/
http://foodtechupdates.blogspot.com 

Thursday, July 21, 2011

GLOBAL FOOD SAFETY-NEED FOR INTERNATIONALCOOPERATION

Why should America be concerned about food safety logistics in other countries? Being a super power the US always behaved imperiously with almost all its trade partners and in stead of a policy of "hand holding", the policy was more concerned with "policing" and "arm twisting". Lately realization has dawned on this country that its own citizens are vulnerable to food safety hazards, though unwittingly, if there is no understanding and cooperation with its trading partners. Food related dangers cannot be avoided but can be tackled more efficiently by working towards a global industry regime practicing universally acceptable safety standards and practices. Of course agencies like Codex Alimentarius Commission is already doing a yeomen service by harmonizing food standards with cooperation from from all UN members but when it comes to logistics and infrastructure many countries find the going tough. It is here that wealthy nations like the US must lend a helping hand through technical and economic assistance to upgrade and modernize safety assessment systems in many countries which are in the export trade sending their foods across the world.
A country like the US cannot deny the fact that two thirds of its fresh produce need and 80% of fish supply come from other countries and this is like exposing its "soft belly" to untoward incidences of dangers from unsafe foods. With terrorism raising its ugly head in many parts of the world, it is a question of time before food becomes a tool for terrorism and if a nation depends too much on imported foods, its vulnerability to food related dangers becomes all the more critical. Probably Americans must have realized this bitter truth and are coming forth for genuine international collaboration for pre-empting such a scenario in future.
A recent report by the Safety agency of the US has brought out these issue clearly and succinctly and according to this vision, there is no alternative to "assembling a global coalition of regulators dedicated to building and strengthening a world-wide product safety net work" for which concerted action is needed. It also envisages "developing global data system and net work to share real time information" which will be useful as a reliable resource material to be shared among member countries. Expanding intelligence gathering, focusing on risk analysis and helping third parties through strengthening of their capabilities are also envisaged. Knowing pretty well that 100% inspection is never in the realm of reality, alternate system will have to be evolved to ensure 100% safety.
The plans as illustrated in the FDA Report are indeed laudable but translating it into actionable program is not going to be easy. For example how is it possible to actually get more inspections done in the countries from where exports arrive at US ports? Most of these nations, engaged in export of raw and minimally processed food materials lack even the basic infrastructure that is far inadequate for carrying out safety related inspections. It is here that large investments are required for capacity building. A country like India gets high marks after the rolling out of the FSSAI though it may take years before even the minimum acceptable infrastructure is established. The question is whether developed countries like the US will ever step into this area and invest in upgrading the infrastructure to a level acceptable to all. It may be a Utopian
dream but cannot be ruled out altogether in the light of frequent serious food poisoning episodes and costly product recalls becoming a routine matter in these rich countries.

It is time to realize that no country, however powerful it may be, can be 100% self reliant when it comes to food production due to many factors and the whole world trade edifice is based on this unshakable truth. Take the examples of countries like Japan, England, Singapore and many others which depend on imports to meet a substantial part of their food requirements because of constraints on land and unfavorable weather conditions, Is it not in the interest of such countries to take those countries, richly endowed with natural resources as genuine partners and invest in their well being? Investments on the food safety infrastructure and technical manpower will be richly rewarding in the long term. The new paradigm of cooperation as enunciated by the FDA of the US must be given highest priority at the UN level without further delay.
V.H.POTTY
http://vhpotty.blogspot.com/
http://foodtechupdates.blogspot.com