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

Thursday, July 9, 2015

American consumer, the law makers and the Science-A big cauldron waiting to boil over!

Though genetically modified foods are predominantly produced and marketed in the United States, most consumers are either unaware of it or are helpless to do any thing to stem this trend of overwhelming GMO containing foods. The safety or otherwise of GMO foods is still a matter that divides humanity into opposing camps, one section finding no fault with them while the others vehemently loathing them. The gravity of the problem can be realized from the fact that even among scientists there is no consensus on this issue and how can one blame the consumer to take a stand on this burning issue. Whatever it is, in the US of to day consumers have no choice but to accept foods made from GMO raw materials and ingredients unless one has the wherewithal to spend a fortune to switch over to 100% organic foods. The fight that is going on to day in that country centers around the so called constitutional right of the citizen to know what he is eating and for that what they are asking is to just declare on the label of products whether GMO ingredients are there or not in the food packet. A well reasoned demand though the industry, politicians and bureaucrats do not think so, obviously because of pecuniary considerations.

Look at the stand taken by the safety watch dogs in that country viz Food and Drug Administration and US Dept of Agriculture both of which considers genetically altered foods "practically" same as their natural counterparts and therefore felt there is no need to specifically mention about their presence in any food on the label. One is left with the impression that the US wants to be a unique country in swimming against international views on almost all issues, probably because of the arrogance of power, being the only super power left in the global landscape after the demise of erstwhile Soviet Union. Other wise it is difficult to explain why it is cocking a snook at 64 other countries which have made label declaration about GMO foods mandatory! Why is this happening in a country which is supposed to be the beacon for all democracies in the world? Obvious answer is the nexus among politicians, bureaucrats and industry lobbyists to deny the consumer his right and make unholy money for their own welfare!

A peep into the American situation will reveal this paradox. According to recent reports a fierce food fight is going on in the Congress over the labeling of genetically engineered foods.with a substantial section of the law makers trying to block any move to enforce mandatory labeling of GMO foods in any part of the country. Is it not a paradox that in a federal system of governance, where states enjoy high degree of freedom to legislate, their right is being usurped by the federal government through an insidious bill that will block the power of states to enact any law that will mandate compulsory labeling of GMO foods! Who are these law makers trying to help? Of course the GMO industry giants who have a stranglehold on the American economy through their close nexus with politicians. This attempt comes in the wake of three states already putting on the statute book law that requires labeling of foods marketed in their area. Attempts in the past by some big states like California to legislate on similar lines were frustrated by saturated misleading campaign by the GMO lobby pumping millions of dollars to brain wash the voters. 
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The attempt to pass a law called "Safe and Accurate Food Labeling Act" if passed asks for setting up a voluntary nationwide labeling system overseen by the federal government. This bill, popularly renamed by the consumer activist groups as "DARK Act", acronym for Deny All the Right to Know" Act! Protagonists of GMO foods invariably argue that about 90 percent of the corn, soybeans and cotton grown in the U.S. are genetically engineered, meaning that the crops have been artificially altered to use less water or resist pests and no calamity has befallen in the country. Also other supporters cite the clearance given by The American Association for the Advancement of Science, the American Medical Association and the World Health Organization all of them who have deemed all GMOs on the market as safe. 
However a major chunk of the consumer community is not convinced fully about the safety of such foods because of the common perception that industry does not have the well being of the citizens in their mind, relentlessly pursuing efforts to increase their profits and the scandals surrounding presence of unsafe chemicals hormones, steroids, transfats,etc further reinforce their distrust about the products churned out by the manufacturers. 

At present there are no government-approved labels to let consumers in the U.S. know which foods are derived from GMOs.It is funny that the US Government wants to leave to individual manufacturers to make any label declaration to indicate that their products are free from GMO ingredients without taking any responsibility to verify such claims! That has prompted many companies to advertise their food as "Non-GMO" by taking the services of existing Non-GMO Project which is a private nonprofit outfit floated by retailers. The group is claimed to be testing food products and do product segregation practices to verify that products with its butterfly seal contain less than 1 percent GMO ingredients. Can it be a long term solution when millions of consumers expect their government to come to their rescue by overseeing such label claims to infuse confidence in such products? If mandatory labeling is anathema to the political class which runs the country, least they can do is to set up a dedicated authority to verify claims of manufacturers that their products are free from GMO substances.Will this happen?  Depends on the intensity of struggle by the consumers on the government to sensitize them on this critical issue.

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

Thursday, December 4, 2014

"FLAVORING" towards self destruction?-The hidden ingredients in industrial foods with uncertain safety credentials

If processed foods have become popular with every segment of the consumer population, the industry must thank two important causes which have driven consumers into their open arms. First the cocktail of flavors churned out by the omnipotent flavor industry which are used liberally by the food manufacturers ever increasingly to attract more and more adherents into their fold. Second the element of convenience built into these products that relieve the house wives from the kitchen drudgery, making available more time for them to go for income generating employment as well as to spend more time with their families. Unfortunately parallel to the rise of food processing industry, two important social and nutritional situations have shifted significantly to a direction considered highly undesirable. The manufactured foods do not transfer the emotions of a mother, where as foods made within the confines of a home have this invisible and immeasurable "wave' reflecting her concerns and love for her siblings as well to the husband. Nutritionally the food industry has focused more on taste and flavor ignoring the health implications their foods will have on the family. Who is the culprit for this undesirable changes in our food environment?

Of course the first culprit could be the consumer himself who unwittingly get trapped by the mouth watering or eye appealing foods offered by the industry because of tireless promotional activity of the market forces as well as his own gullibility to fall for best tasting foods instead of moderating that desire to factor the health effect of such foods. From time to time pundits, be it psychologists, food scientists, sociologists, medical community or government agencies, have been discussing regarding why the consumer, ignoring his own health, flock to junk foods with empty calories and court diseases like obesity, CVD, Diabetes, Blood Pressure, Cancer etc through wrong eating practices. Probably there may not be a single cause that must be driving the consumers to such health damaging foods. Governments world over try to persuade the consumers to shun fast foods and junk foods through education and consumer guidance which do not seem to be working at all if obesity statistics in some countries like the US are to be believed.

Biologists consider the weakness of most people to junk foods and over eating due to factors like genetic make up, brain functions, hormonal dynamics, etc though there are no compelling evidence generated through human clinical trials of any substantial size and spread to support any of them. Sociologist feel that man's eating surge cannot be controlled through government policies though such interventions are not feasible in a democratic country with a constitution giving primacy to personal freedom and inalienable rights. The  recent attempt in New York to limit sale of jumbo sized foods and drinks ended up in a fiasco because of judicial road blocks. Taxing "bad" foods on a punitive scale tried in many countries also had practically no impact on the situation. Proximity to fast food outlets to residential areas was once cited as reasons for over eating by a section of the population and strict zoning regulations were considered for making the "fans" of junk foods to travel an extra mile to get to an eating frenzy mood. Well being industry puts out from time to time products claimed to be helpful in overcoming obesity and over weight problems but they can be at best a fire fighting operation, not striking at the root of the problem. 

Flavor industry is the least controlled one with practically no transparency in their working. No one knows what chemicals are used by them to concoct various flavor potions for use by the  food industry in different products. Flavor consists of four distinct components, viz color, aroma, taste and texture. Talking about taste we have four recognized ones that include sweetish, salty, sourness and bitterness. Pungency and Umami are also taste variants commonly patronized from specific cultural groups. Food processing industry over the years has realized that uniformity in quality is difficult to achieve when widely varying quality natural raw materials are used and in its pursuit to provide uniform quality finished products they use a variety of artificial, synthetic and flavor concentrates recovered from natural sources to standardize the products from batch to batch. Unfortunately the number of chemicals being used for this purpose is burgeoning during the last three decades and no one, including the safety authorities is sure about their safety in the long run. 

Imagine the situation now obtaining in the food production system where more than 12000 chemicals are reported to be deployed for a variety of purpose. Out of these, safety data are available only on about 5% with the remaining ones posing potential health hazards to the consumers. Food processing industry uses about 3000 additives, mostly synthetic chemicals for improving their end products to make them more attractive to the consumers. These include, acids, acidity regulators, anticaking agents, antifoaming agents, antioxidants, bulking agents, colorings, color stabilizers, emulsifiers, fillers, flavor ingredients, flour treating agents, glazing aids, humectants, raising agents, preservatives, stabilizers, sweeteners, thickeners, viscosity modifiers, nutrients, health boosters, texture modifiers etc. Whether all of them are really needed is a million dollar question for which there is no ready answer as of now.  However emergence of organic food industry has shown the way that good quality food products can still be made without using artificial additives during processing.

Consumer activist organizations are now coming together to deal with the "menace" of indiscriminate use of so called flavors by the main stream food industry and in a country like the US the movement is assuming critical proportions compelling the safety authorities to wake up to the ground reality. At present the onus of deciding about the safety of flavor chemicals rests with the flavor industry and the safety agency is a silent side player, waking up only if there is any serious incidence of harm caused by any such chemical to the consumer as reported through a complaint. It is most unfortunate that the only remedial action is generally banning that particular flavor after perfunctory examination of the case, Is this the right way to protect the consumer? Is it not most unfortunate that the globally renowned USFDA, a role model for safety agencies world over, is shirking its responsibility to its constituency, viz the citizens of that country? Common sense tells that no chemical, especially the ones synthesized in the laboratory, can be safe unless proved by human clinical trials to be safe for use in foods and this basic principle seems to be ignored possibly because of the political and financial clout of the flavor industry. One can only hope that this situation will get rectified through the renewed initiatives now being launched by various consumer groups.

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

Wednesday, April 2, 2014

THE "GRAS" MESS!-WHO CARES FOR THE CONSUMER, ANY HOW!

Many consumers are lulled into believing that if a food product contains an ingredient that is declared as Generally Recognized As Safe ("GRAS") is really safe to consume. But few realize the real meaning of GRAS and who decides about the GRAS status of a substance. According to recent reports there is a conflict of interest on the part of the manufacturer because such determination about GRAS is made by the manufacturer himself with no independent verification by any statutory authority. Probably the underlying philosophy seems to be that industry will never compromise on the safety of the consumer. Unfortunately this is a travesty of truth and history is replete with instances about many GRAS ingredients causing serious health problems, long term as well as short term.

Those who propound the theory that industry should have such a liberty hide under the provision of safety act that the regulatory authority concerned can always haul the culprits if their claim is found to be untrue. world over regulatory agencies find themselves unable to monitor and implement statutory rules let alone take up responsibility like checking the safety of the so called GRAS substances used by hundreds of manufacturers without safety clearance. Of course there is a provision that if challenged the user industry must provide data to back up their claim to classify the ingredients under GRAS list. Here is the latest instance of the US food industry using a sweetener enhancer, presumably synthetic in nature, under the garb of GRAS and the reaction by experts on this ill defined provision allowing use of ingredients self declared as GRAS 

"What does it mean when a food ingredient is labeled "safe"? The question seems straightforward, but the answer proves to be disorienting. Recently, the biotechnology company Senomyx, Inc. was in the news following confusion over a safety determination for one of its products. The San Diego-based company develops, manufactures, and sells a variety of flavor ingredients for use in food and drinks. Their latest product – a flavor modifier called Sweetmyx – is a "sweetener enhancer," which allows food and beverage manufacturers to reduce sweetener use while maintaining taste intensity. Under a 2010 agreement, Pepsi holds exclusive rights to use Sweetmyx in non-alcoholic beverages.

On March 11, Senomyx issued a statement announcing, "Sweetmyx flavor ingredient, previously referred to as S617, has been determined to be Generally Recognized As Safe (GRAS) under the provisions of the Federal Food, Drug and Cosmetic Act, administered by the United States Food and Drug Administration (FDA)." Shortly after the announcement, news outlets reported that Sweetmyx had been determined safe by the FDA. A Reuters headline read, "FDA says Senomyx sweetener enhancer safe" while a subhead by the financial news outlet Barron's declared, "The biotech received a nod from the FDA for the sweetener Sweetmyx." Subsequently, the value of Senomyx stock shares jumped as high as 26 percent on the day before closing up 17 percent. So what's the problem? The FDA Does Not Determine "Generally Recognized As Safe" Status. 

The FDA issued a statement the day after Senomyx's announcement, underlining the fact that the agency had not made the GRAS determination and even going so far as to chide Senomyx. "When making a GRAS self-determination, companies should not state or imply that the FDA has made a GRAS determination on their food ingredients," the agency said. Whether or not the wording of Senomyx's announcement was purposefully misleading, the situation did highlight serious confusion over how GRAS determinations are made and what it means for food ingredients to be labeled "safe." The GRAS Process For new ingredients (or by legal terms, "substances") to be added to food, companies must comply with the Federal Food, Drug, and Cosmetic Act of 1938. Food Safety News points out that under the law, "Substances are added to food either as food additives or as GRAS. The difference between the two paths is significant: FDA must sign off on food additives, but companies can use GRAS substances without FDA approval. Notably, companies make their own GRAS determinations, which they may or may not voluntarily submit to FDA for review."

Is it not a tragedy that the manufacturer of the above product, scientific community, user industry and the regulatory agencies indulge in an ostrich like policy without bothering to think about the far reaching consequences of using substances with very little understanding of its nature in day to day products. The secretive way in which such things happen with sickening regularity must be frowned upon and there must be international protocols that stipulate the methodology for assessing safety of food ingredients.  

For further reading refer http://www.foreffectivegov.org/node/12979http://www.foreffectivegov.org/node/12979

V.H.POTTY

http://vhpotty.blogspot.com/
http://foodtechupdates.blogspot.com

Sunday, October 30, 2011

ARTERY CLEANING FOODS-A NEW GIMMICK?

Those who suffer from artery "clogging" due to high cholesterol content in the blood must be excited about the news that it is possible to de-clog the arteries without any medication like Statins. The multi billion dollar Statin industry that thrives on atherosclerosis disease affecting millions of people across the world is soon going to have a competitor with better credentials! Of course one will naturally ask the question as to why people suffer from clogging of arteries which can manifest in myocardial infarction or stroke, if adequate discipline is exercised regarding the diet one consumes. Unfortunately even the best psychologists in the world cannot answer the question because human behavior is not amenable to change easily and food consumption practices are evolved over years, influenced by economic factors and the living environment.

The most manifested symptom of arterial clogging, chest pain, is treated with prescription medicines but invariably the affected person ends up too often under the knife of a cardiac surgeon. As arteries that supply blood to the heart muscle gradually become blocked by plaques of cholesterol, fat, cells, and debris, the heart muscle is starved of oxygen. Drugs that are in the market may reduce the pain temporarily though eventually the patient has to seek surgical remedy. Coronary bypass operation or a plaque - busting angioplasty is necessary to restore blood flow to the heart. The alternative is a heart attack and such bypass operations are becoming routine these days in many affluent countries. The surgical intervention is not considered absolutely safe with some unable to survive the procedure. In about 6 percent of cases, it is known to cause brain damage. Another bitter fact is that it is not a permanent cure with the patient forced to go back to the hospital within six to eight years for a repeat of the surgery to repair the arteries again.

An oft repeated question is whether medical intervention is absolutely necessary to restore the health of the arteries and some believe there are alternative choices. It is now realized that clogging of arteries can be reversed through appropriate foods or supplements now being developed by some health products companies. Foods like garlic, oats, soy products, beans and walnuts seem to have the property to reverse clogging if consumed in optimal quantities regularly. The ability of arteries to clean themselves without the help of medicines, if simple diet and lifestyle changes are adopted, has been amply demonstrated and has been accepted by the medical fraternity. Under the right diet and exercise regimen, blockages in the arteries actually shrink significantly within an year. It was in 1990 that the role of diet in reducing atherosclerosis was brought out unambiguously when subjects with varying degree of atherosclerosis found their arteries getting rid of bad cholesterol on a vegetarian diet regimen compared to those consuming preparations with meat and fish regularly.  

The role of dietary fiber in reducing cholesterol levels in the blood is now well established. Its ability to "wash out" the cholesterol from the GI tract and not allowing it to be reabsorbed across the intestine is recognized. The recommendation to include 25-30 gm of fiber in daily diet has arisen out of the above conviction and dietary fiber has spawned an industry which sells fiber-rich supplements made from different sources. Even many "synthetic" dietary fiber preparations are being marketed though they cannot work as efficiently as natural fibers from whole cereal, pulses, fruits and vegetables. As the evidence about dietary fiber helping to reduce cholesterol has not been established conclusively through human studies of significant scale, any claim to be printed on the label of a food is some what premature. As the control regime on food supplements is not very strong, many manufacturers get away by making such claims to boost business.

The difficulty in accepting the limited evidence is due to the diverse nature of fibers used in different studies and the tendency to generalize the findings. To date FDA of the US had accorded approval to a Tomato extract that was proved to be effective as a blood thinner in place of Aspirin which is not recommended for normally healthy persons due to its adverse effect on gut health and hemoglobin level and its relatively long metabolic life of 20 days. How ever active efforts are on to get a few products cleared for arterial cleaning and one of them made from a Chitin-glucan fraction derived from Aspergillus niger seems to be promising. The human trials currently underway can only confirm its efficacy as an acceptable artery cleaning supplement.

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

Thursday, February 26, 2009

BUYER IS SUPREME: THE SELLER HAS NO CHOICE!



Food industry in India has achieved significant strides during the last 2 decades and food exports are increasing with more and more access to new markets, earning valuable foreign exchange. Quality and safety problems pose serious threats to smooth exports and frequent rejections of Indian foods in foreign ports are routine. Advent of protocols under ISO, HACCP, SAP etc was expected to help instill confidence amongst the buyers regarding the quality of food manufactured by the licensed production units. But this has not worked the way it was expected to do if we go by the records of the industry so far. The Salmonella scare of 2008 affecting tomatoes and jalapeno pepper, the latest involving peanut butter in USA and melamine tainted milk powder in China conclusively prove that there is no substitute to honest and conscientious efforts by the industry to discipline itself by eternal vigilance and uncompromising approach vis-a-vis safety and quality.

On an earlier occasion this blog had commented on the steps taken by FDA of USA to open offices in some parts of China, obvious intention being to pre-empt safety related problems affecting imports into USA. This action is on the premise that active involvement of the importer in the operations of the manufacturer would some how ensure strict compliance. Same approach was evident when FDA announced setting up of two offices in Delhi and Mumbai under the impression that every thing will be alright now on wards. But if the past records are any indication, it is doubtful if such intrusive steps can deliver the expected results.

FDA, which is under fire in its own country for its failure to protect the consumers due to the inefficient surveillance system in place, is burdened with both drug and food portfolios and it is not able to do justice to either of them. The open letter addressed by 100 scientists to the new President highlighting the corruption in FDA is still fresh in our memory. There is clamor for splitting FDA into two separate bodies, each devoting to drugs and foods exclusively. Added to this is the split responsibilities for food safety between USDA and FDA, former looking after meat and poultry regulation, rest being under FDA.

The current controversy on peanut contamination with Salmonella, originating in a plant in Georgia, was glaring at the regulators since 2001 but still no concrete action was taken to bring them to books. Interestingly this particular plant was regularly inspected by USDA personnel since the peanut butter supplied by this firm is distributed to school children under the national feeding program and still the culprit was not hauled up for violation of good manufacturing practices! This has caused recall of 1550 products in 45 states in the US because of the 575 illnesses reported due to peanut consumption. More scandalous is the fact that the peanut butter consignment rejected by the Canadian food authorities reentered USA through a border bridge between New York State and Canada though it was found to contain "filthy, putrid or decomposed substances unfit for food". The plant that manufactured the peanut butter under cloud in Atlanta, GA, was inspected by FDA authorities in 2001 and indicted for presence of cockroaches, molds, leaking roof and other sanitation problems but no follow up action was taken. USDA inspectors visited this plant routinely there after since peanut butter from this plant is regularly supplied for the school feeding programs across the country. A typical example of right hand not knowing what the left hand is doing!

If this is the efficiency of their surveillance program within USA, what a few officers, operating from the embassy in Delhi and consular office from Mumbai can achieve is a matter of conjecture. Probably the intrusive action may only delay shipments creating further problems to the Indian industry. It may justifiable for our industry to demand that once FDA clears their shipments in India there should not be any further time consuming procedural delays at the importing points. If this happens, some of the uncertainties associated with food exports to USA can be avoided. Since consumer is the king the seller may not have such a leverage with buyers under to day's economic scenario. At least Indian food industry can try striking a deal mutually acceptable to both the parties.

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