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Showing posts with label GRAS. Show all posts
Showing posts with label GRAS. Show all posts

Thursday, July 2, 2015

GRAS Vs GRAS-The great food additives deception on the consumer

Can any normal person be proud to be an American to day when it comes to food safety and medical services prevalent in that country? Of course on many counts Americans can hold their heads high due to their hard working, generally honest and efficient way of life styles developed over a period of two centuries. With economic might and free enterprise spirit, there appears to be a shift in the power from the average citizen to the military-industry complex that emerged after world war II. This is more than amplified by the power and economic muscle of vested interests that lord over the citizen to day. The nexus between powerful industrial lobbies with least concern for the well being of their people and vote garnering politicians is too apparent in every sphere of activity in that country. Read the report below about the behavior of food industry in that country and how effective or ineffective is the food safety vigilance system there putting the health of the citizens in great jeopardy. Reference here is about the so called GRAS system of allowing hundreds of chemicals with questionable safety record being allowed to be used by the food safety administration agency in the US. 

"When President Eisenhower signed the Food Additives Amendment of 1958, he established a regulatory program intended to restore public confidence that chemicals added to foods are safe. In the intervening 56 years, the basic structure of the law has changed little. However, the regulatory programs the U.S. Food and Drug Administration (FDA) established to implement the law have fallen behind over time as the agency strived to keep up with the explosion in the number and variety of chemicals in food, and to manage its huge workload with limited resources. The 1958 law exempted from the formal, extended FDA approval process common food ingredients like vinegar and vegetable oil that are "generally recognized as safe" (GRAS). It may have appeared reasonable at the time, but that exemption has been stretched into a loophole that has swallowed the law. The exemption allows manufacturers to make safety determinations that the uses of their newest chemicals in food are safe without notifying the FDA. The agency's attempts to limit these undisclosed GRAS determinations by asking industry to voluntarily inform the FDA about their chemicals are insufficient to ensure the safety of our food in a global marketplace with a complex food supply. Furthermore, no other developed country in the world has a system like GRAS to provide oversight of food ingredients. Why Did Companies Forgo the FDA Notification Review Process  Because of the apparent frequency with which companies make GRAS safety determinations without telling FDA, NRDC undertook a study to better understand companies' rationale for not participating in FDA's voluntary notification program. First, we built a list of companies and the chemicals they made. Then we reviewed public records, the company websites, and trade journals to identify chemicals that appear to be marketed in the U.S. pursuant to an undisclosed GRAS determination, i.e. without notification to the FDA. All told, we were able to identify 275 chemicals from 56 companies that appear to be marketed for use in food based on undisclosed GRAS safety determinations. This is likely the tip of the iceberg -- we previously published in an industry journal an estimate that there have been 1,000 such undisclosed GRAS determinations. For each chemical we identified in this study, we did not find evidence that FDA had cleared them. In addition, using the Freedom of Information Act (FOIA), we obtained from the FDA copies of communications between the agency and companies who voluntarily sought agency review of their GRAS determinations. We found that this glimpse into the review process shows that often the agency has had serious concerns about the safety of certain chemicals, and that companies sometimes make safety decisions with little understanding of the law or the science. As discussed later, companies found their chemicals safe for use in food despite potentially serious allergic reactions, interactions with common drugs, or proposed uses much greater than company-established safe doses. On those occasions when the FDA is asked to review a GRAS determination, the agency rejects or triggers withdrawal of about one in five notices. Moreover, the public has even less information about the many substances with GRAS determinations that are never submitted to the agency in the first place -- and which may pose a much greater danger. It is often virtually impossible for the public to find out about the safety -- or in many cases even the existence -- of these chemicals in our food. NRDC believes that"Generally Recognized as Secret" rather than "Generally Recognized as Safe" is a better name for the GRAS loophole. A chemical cannot be "generally recognized as safe" if its identity, chemical composition, and safety determination are not publicly disclosed. If the FDA does not know the identity of these chemicals and does not have documentation showing that they are safe to use in food, it cannot do its job. In an increasingly global marketplace where many additives and foods are imported into the United States, this loophole presents an unsettling situation that undermines public confidence in the safety of food and calls into question whether the FDA is performing its duty to protect public health. The problem is rooted in a law adopted in 1958 when Eisenhower was president and Elvis was drafted. It is time for the FDA and Congress to fix the problems. In the meantime, consumers need to demand that their grocery stores and their favorite brands sell only those food products with ingredients that the FDA has found to be safe."

One has to be sympathize with the condition prevailing in that country in spite of stringent laws that exist on the statute books. No where else in the world the food manufacturers are given free hand in deciding what chemical is to be added based on flimsy scientific data sourced from within or from doubtful sources. It is true to redefine GRAS as secret list of chemicals used by the industry without proving they are safe. Can this continue for long? Citizens must raise their voice against such an obnoxious system that controls their lives. Compared to USA, EU countries are some what better off as there is better governance as far as safety monitoring is concerned. It is time that all GRAS additives are brought under a critical scanner and compel the industry to use only those found to be safe through impeccable scientific scrutiny.

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

Thursday, September 5, 2013

NEITHER FAR SIGHT NOR FORESIGHT! -FOOD ADDITIVES REGULATION

Who is overseeing the activities of the food processing industry in each country? There are designated agencies vested with legal powers and responsibilities to regulate the manufacturers so that citizen's health is not compromised. Such agencies have to evolve scientific standards, methodologies for testing and exercise vigilance over the market. No doubt it is a gigantic task requiring adequate personnel with right background and high quality infrastructure. Most of all it requires a will, determination and commitment on the part of the safety agencies to perform this onerous task. In reality what is happening is a systematic shirking of this responsibility in connivance with the food processing industry which stands to benefit financially through exorbitant profits by diluting standards and safety parameters systematically. Here is an expose about the lackadaisical approach of the Government in the US and consequently the potential dangers faced by the helpless citizens in that country.  

"As the new JAMA analysis shows, even when they choose to inform the agency, those notifications are made by people with a "vested interest" in the industry whose products they are evaluating. About 22 percent of the 451 additive safety notices that were submitted to the FDA between 1997 and 2012 were drafted by an employee of the food additive manufacturer itself. An additional 13 percent were written by consultants that work with firms hired by the food industry. The remainder of the notifications were written by panels of food safety experts — but every single one of those panels' members were hand-picked either by the food industry or consultants working for the food industry. Additives that can't preemptively be considered GRAS, such as food coloring and preservatives, are subject to higher standards of scrutiny. Food companies must submit relevant data about possible harmful effects, chemical composition, and any investigations surrounding the additive's safety to the FDA. But the FDA-issued guidelines regarding the proper level and method of testing for these products aren't legally binding for food corporations. So if a substance — GRAS or otherwise — is eventually found to be harmful, the FDA has to wait until there is clear evidence of its harmfulness before it can pull its approval, work to revoke its GRAS notification, initiate a recall, or institute reforms such as limiting how much of the substance may be put into food. Even these steps may be met with fierce resistance from the corporate food lobby, which stymied labeling requirements for deadly trans fats for a decade and continues to fight proposed limitations on salt content. These lapses in oversight — and the evidence indicating that the food industry is in essence self-regulated — led the JAMA researchers to call for major reforms. The authors write that the FDA should bar people with ties to the food industry from submitting GRAS or additive safety notifications, move from a voluntary system of GRAS notifications to one that requires companies to inform the FDA whenever they determine a substance to be GRAS, have corporations report conflicts of interest when it comes to assessing an item's food safety, and release all relevant information to the public". 

Conceded that in order to sustain the food industry there has to be minimum interference and intervention by government authorities but former has to keep in mind the well being of the consumers upper most. Profit at any cost is just not acceptable when it comes to operating in a society which provides bread and butter to the industry. It is galling to see how much freedom is given to food industry in this country, even leaving the responsibility of developing standards and safety protocols to them to decide. Probably the powerful lobbying interests are checkmating every government move to better the standards and safety of foods, fearing adverse impact on their bottom line. Self regulation is a wonderful thing but it rarely works effectively because safety issues are always debated ad naseum  with no consensus leaving the issues unresolved endlessly benefiting the industry by allowing to practice what they consider desirable from their view. The labeling campaign for GMO foods is the most classical example of prevarication by the government and the extraordinary clout the industry enjoys with the government. This situation must end, if American citizens who consume as much as 80% of their diet made up of packed foods, are to be liberated from the tyranny of the food industry, controlled mostly by a few giant monopolistic monoliths!

Wednesday, March 7, 2012

NEW COMPENDIUM ON INGREDIENT STANDARDS-FOOD CHEMICAL CODEX


Many of the food ingredients being used in the past and at present are viewed with suspicion by the consumers and the food industry seems to be getting more and more sensitive to these concerns. There are many food additives coming under the category of GRAS ( Generally Recognized As Safe) which was supposed to assure that they are safe but unfortunately no review system is in place to continuously assess their safety, in spite of newer and more sensitive methodologies emerging and  more scientific data available. Food Chemical Codex (FCC) provides updated information on all aspects of chemicals used by food and pharmaceutical industries and serves as a common denominator for comparison and assessment of foods through out the world. The 8th edition which was recently brought out is a veritable source of information useful to the industry.   

"The latest specifications for the identity, quality and purity of more than 1,100 food ingredients, test methods to verify specifications, key guidance on critical issues such as impurities testing for metals, and full content from an upcoming Food Fraud Database are all included in the new Food Chemicals Codex (FCC), Eighth Edition. Published by the U.S. Pharmacopeial Convention (USP), FCC is a compendium of internationally recognized standards for the authenticity of a wide variety of ingredients including colorings, flavorings, nutrients, preservatives and processing aids. Via FCC, USP provides a unique combination of specifications for the authenticity and quality of each ingredient and test methods to verify these specifications, as well as reference materials suitable to confirm that the test methods are executed appropriately and measurement results therefore can be trusted. "The food industry is constantly innovating with new products and ingredients designed to meet consumer desires for healthful, flavorful and convenient foods," said Praveen Tyle, Ph.D., USP executive vice president and chief science officer. "At the same time, manufacturers are increasingly sourcing their ingredients globally. Public standards provided by FCC can serve as a key resource for manufacturers in managing their supply chains by providing specifications to authenticate their ingredients, and can also help differentiate suppliers. These standards may be particularly important for more complex, natural ingredients and for high-value ingredients, where price competition is fierce. Quality standards for ingredients can help ensure all parties have the same expectations regarding required quality, which can be written into contractual agreements, and can help protect against substandard ingredients—one of the safety nets for the global food supply chain," Dr. Tyle continued.
It is a reality that no country in the world can live in isolation and interdependence in many areas is unavoidable. Global sourcing of food materials and ingredients has become common and such a procurement system requires standards and assessment methods acceptable o the suppliers as well as the buyers. FCC standards provide such a reference source serving world trade admirably well.
With agencies like ISO, WHO/FAO Codex Alimentarius Commission and others also in this field there is an urgent need to harmonize all the standards under one proof. Duplication of efforts by different organizations in the same area is best avoided.

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

Sunday, March 13, 2011

CELLULOSE ADDITIVES IN FOODS-GOOD OR BAD?

Some times food industry can be wrongly indicted for doing things which some consider as undesirable. No doubt many practices being indulged by the industry deserve to be condemned in no uncertain terms and deterrent action taken with no leniency shown against proven culprits. But the latest issue which is being raised to insinuate the processing industry cannot be justified if a scientific assessment is made dispassionately. Use of cellulose which is not digested in human GI tract, often included in food formulations is considered harmless and is permitted by law. To castigate the industry that it is making people eat "wood pulp" is outright childish and preposterous.

"Chief among those concerns is the use of cellulose (read: wood pulp), an extender whose use in a roster of food products, from crackers and ice creams to puddings and baked goods, is now being exposed. What you're actually paying for -- and consuming -- may be surprising. Cellulose is virgin wood pulp that has been processed and manufactured to different lengths for functionality, though use of it and its variant forms (cellulose gum, powdered cellulose, micro-crystalline cellulose, etc.) is deemed safe for human consumption, according to the FDA, which regulates most food industry products. The government agency sets no limit on the amount of cellulose that can be used in food products meant for human consumption. The USDA, which regulates meats, has set a limit of 3.5% on the use of cellulose, since fiber in meat products cannot be recognized nutritionally".

Cellulose, if it is of food grade is a dietary fiber required for good health and according to expert recommendations an average adult must consume 25-30 gm of fiber daily to prevent development of a number of diseases. There are many natural sources of fiber with varying molecular structure and properties. While naturally occurring substances like beta glucan and pectin come under the soluble fiber category, cellulose and a host of non-starch carbohydrates serve as insoluble fiber. Both soluble and insoluble fiber are considered essential for good intestinal health in humans. Production of short chain fatty acids including butyrate in the human bowel by "friendly" microbes helps to strengthen tissues besides providing protection against some form of cancer. As long as the cellulose ingredients used is derived from edible plant sources, one should have no objection regarding their presence in processed foods. The levels of use are self-limited by the changes that will be evident if too much of this ingredient is incorporated in the food and besides its role in nutrition, cellulose also serves the technological necessity in creating desirable mouth feel in many products.

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