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By: Daniel Gastelu
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However, recently members of congress introduced a bill that would certainly have adverse effects on how dietary supplements are sold in the U.S.A. The bill is referred to H.R. 3156, Dietary Supplement Access and Awareness Act, which I'll refer to as DSAA. Ironically, DSAA would actually restrict access and awareness of dietary supplements in the U.S.A., and ultimately cause the price of dietary supplements to increase. In this article I will present a quick overview on how dietary supplements are currently regulated, and why the good Act, DSHEA, should be supported, and why the proposed bad Act, DSAA, should be opposed by using the e-mail tool to let your Congressmen and Senators know that you oppose the DSAA.
Dietary supplements have always been regulated as foods in the U.S.A. In 1994 the Dietary Supplement Health and Education Act was passed, which created a more formal subcategory of foods that is referred to as dietary supplements to acknowledge some special aspects of making and selling dietary supplements when compared to conventional foods. While the DSHEA is not perfect, like with any law, it has broadened access to all types of dietary supplements in the U.S.A., and has allowed manufacturers and marketers of dietary supplements the ability to make claims for the products they sell, i.e., access and awareness. The DSHEA is a fantastic law, and recognizes all the good that dietary supplements have to offer people and the ability to tell people about most of them. As I previously mentioned, dietary supplements are actually a subcategory of foods. So when people take the time to read the code of federal regulations that governs foods and dietary supplements, referred to as 21CFR, there is already plenty of rules and regulations that allow the FDA to stop the sale of a food or drug product if it posses harm or threat to human health (see below for sample of contents of and link to 21CFR online. FDA routinely recalls foods that just have mistakes on their labels. In fact, on a regular basis the FDA is stopping the sales of drug and food products that may be harmful or pose a threat. For example, the following are some recent regulatory actions taken by the FDA, with a link to the page on the FDA website for more actions and details on those listed below. It is interesting to note that out of the dozens of these FDA product recall, market withdrawal and safety alerts listed from May 2005, dietary supplement products are not found on the list, but many for conventional foods, drugs and drug devices. And in the rare instance when dietary supplement products are implicated in a recall, it is usually because the manufacturers used unauthorized ingredients like drug ingredients.
You can visit http://www.fda.gov/opacom/7alerts.html for more FDA recalls, market withdrawals and safety alerts. The follow are some examples of the regulatory actions taken against dietary supplements that were suspected of being a potential problem. Again, this illustrates that the current FDA laws and regulations already give FDA the ability to take action to remove products from the market place that are or may be harmful to health:
The required warning for iron containing products is:
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Members of Congress just can't seem to leave well enough alone. Instead of dreaming up new ways to undo what is working extremely well, they should focus their energy on working together to build on the strong foundation the DSHEA has created, and determine ways to make more dietary supplements available to us and allow for more claims based on the thousands of studies published each year that provide strong evidence about how dietary supplement benefit our health, performance and well-being.
You can read the report online at: http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat1a.chapter.2159 Or get a copy for free by from the AHRQ Publications Clearinghouse by calling 1-800-358-9295. Requesters should ask for Evidence Report/Technology Assessment No. 64, S-Adenosyl-L-Methionine for Treatment of Depression, Osteoarthritis, and Liver Disease.
The DSHEA is a well conceived and constructed Act; it does not need to be undone or fooled around with. Members of the Congress and Senate did a great job when they passed this Act back in 1994. If members of Congress have safety concerns, they should work with FDA to make sure that FDA has the adequate staff to do more inspections and review the products being made under current laws and regulations. There is no need for new laws like DSAA to do this.
Here is the link to 21CFR so you can review and read the Food and Drug regulations for yourself. I also included some of the contents links relevant to this subject matter.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
§ 7.41 - Health hazard evaluation and recall classification. § 7.42 - Recall strategy. § 7.45 - Food and Drug Administration-requested recall. § 7.46 - Firm-initiated recall. § 7.49 - Recall communications. § 7.50 - Public notification of recall. § 7.53 - Recall status reports. § 7.55 - Termination of a recall. § 7.59 - General industry guidance. Subpart A -- General Provisions
§ 101.2 - Information panel of package form food. § 101.3 - Identity labeling of food in packaged form. § 101.4 - Food; designation of ingredients. § 101.5 - Food; name and place of business of manufacturer, packer, or distributor. § 101.9 - Nutrition labeling of food. § 101.10 - Nutrition labeling of restaurant foods. § 101.12 - Reference amounts customarily consumed per eating occasion. § 101.13 - Nutrient content claims general principles. § 101.14 - Health claims: general requirements. § 101.15 - Food; prominence of required statements. § 101.17 - Food labeling warning, notice, and safe handling statements. § 101.18 - Misbranding of food. Subpart B -- Specific Food Labeling Requirements
§ 101.30 - Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice. Subpart C -- Specific Nutrition Labeling Requirements and Guidelines
§ 101.42 - Nutrition labeling of raw fruit, vegetables, and fish. § 101.43 - Substantial compliance of food retailers with the guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish. § 101.44 - Identification of the 20 most frequently consumed raw fruit, vegetables, and fish in the United States. § 101.45 - Guidelines for the voluntary nutrition labeling of raw fruits, vegetables, and fish. Subpart D -- Specific Requirements for Nutrient Content Claims
§ 101.56 - Nutrient content claims for light or lite. § 101.60 - Nutrient content claims for the calorie content of foods. § 101.61 - Nutrient content claims for the sodium content of foods. § 101.62 - Nutrient content claims for fat, fatty acid, and cholesterol content of foods. § 101.65 - Implied nutrient content claims and related label statements. § 101.67 - Use of nutrient content claims for butter. § 101.69 - Petitions for nutrient content claims. Subpart E -- Specific Requirements for Health Claims
§ 101.71 - Health claims: claims not authorized. § 101.72 - Health claims: calcium and osteoporosis. § 101.73 - Health claims: dietary lipids and cancer. § 101.74 - Health claims: sodium and hypertension. § 101.75 - Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease. § 101.76 - Health claims: fiber-containing grain products, fruits, and vegetables and cancer. § 101.77 - Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease. § 101.78 - Health claims: fruits and vegetables and cancer. § 101.79 - Health claims: Folate and neural tube defects. § 101.80 - Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries. § 101.81 - Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHD). § 101.82 - Health claims: Soy protein and risk of coronary heart disease (CHD). § 101.83 - Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD).
PART 110 Subpart A -- General Provisions
§ 110.5 - Current good manufacturing practice. § 110.10 - Personnel. § 110.19 - Exclusions. Subpart B -- Buildings and Facilities
§ 110.35 - Sanitary operations. § 110.37 - Sanitary facilities and controls. Subpart C -- Equipment
Subpart D [Reserved] Subpart E -- Production and Process Controls
Subpart F [Reserved] Subpart G -- Defect Action Levels
Now on to taking a closer look at DSAA. The following is a draft of the bill that was introduced to the House of Representatives on June 30, 2005. Take a quick read through it, and I'll review some of the main points about why this bill is not needed and how in the long-term it can actually be used to restrict access to dietary supplements, as well as make them very expensive to make.
View The Bill Here.
First and foremost, the food and drug regulations already provide for safety and record keeping. Under good manufacturing practices (GMPs, also abbreviated cGMP) companies that make foods (dietary supplements), drugs and medical devices are obligated to make safe and effective products and keep records and report adverse events to FDA if they occur. Additionally, food manufacturers are already required to register their facilities with the FDA under a separate Act: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA. Who Must Register? Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA. Domestic facilities are required to register whether or not food from the facility enters interstate commerce. Foreign facilities that manufacture/process, pack, or hold food also are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register. Examples Of FDA-Regulated Foods:
In the long-term the DSAA will actually limit access to dietary supplements, by creating an unnecessary mountain of paper work being submitted to the FDA, which will create a need to spend millions and millions of dollars of our tax dollars to hire people to organize and file this paperwork. This will actually take away from the FDA working in the field to inspect and monitor manufacturers of foods and drugs. This unnecessary paperwork will result in higher manufacturing costs and higher prices of dietary supplements, and not solve any real safety problems. The DSAA arbitrarily selects out certain dietary supplement ingredients that are vitamins and minerals from being exempt, and selectively includes botanical, amino acids, concentrates, metabolites (like creatine and carnitine), constituents, extracts or combinations of vitamins and minerals. This will undo the tremendous amount of good that the DSHEA has accomplished. All the other double talk and extra record keeping provisions of this proposed DSAA are equally unnecessary and unwarranted. Aside: The people at the FDA, who actually have to implement the Acts, also need our support. Even though they get ridiculed by some radical people and companies in the press they are a great group of highly trained professionals that I have the utmost respect for. While I dont always agree with them, the FDA personnel consist of highly educated and esteemed health professionals, and like us, they want what is best for our national health. The lawmakers, rarely if ever work side-by-side with the expert FDA personnel and other federal agencies when they are writing their laws; perhaps except for during an appearance at a question and answer hearing. So in the end, it is the non-expert politicians writing up the all to often unpractical, redundant and unnecessary laws, without getting the experts involved in the writing process who know what is really best based on their professional experience. After the laws are passed, the experts have to try to make sense of them, and hire more people to do things that are not necessarily the best solution or the best way our tax dollars should be spent. What the FDA needs right now is to hire more people to get done what they know needs to be done, instead of wasting their time and our tax dollars on new unnecessary new laws.
Dietary supplements have one of the best safety records of any product, ingestible or otherwise. Dietary supplements save lives, make people healthier, and there are tens and thousands of studies that show dietary supplements can help prevent, treat and cure many disease. The data is so impressive that the FDA has passed health claims for dietary supplements that recognize how they can be used to prevent diseases like cancers and heart diseases. Yet, with all the good that dietary supplements have to offer people, some politicians are constantly trying to limit our access to them. Meanwhile, conventional foods, drugs, tobacco and alcohol cause more harm to people in one day, then dietary supplements caused over the past 100 years (which serves as evidence to support that dietary supplements are very safe). When there is a problem with food or drug products, the FDA has the authority to act quickly to stop the sale of the problem product. Each year you read about drugs that have been removed from the market due to health problems. Regarding food, food borne diseases make millions of people sick each year, and hundreds of thousands people die each year. Add to this the adverse effects of eating unhealthy foods which contribute to causing cancer, cardiovascular diseases, diabetes and other diseases, but yet politicians see no need to pass laws to solve these very big problems that are slowly killing our nation and causing us to spend a trillion dollars a year due to a nation consisting of a growing number of unhealthy people.
If you are like me, you are probably perturbed at the way things are being done in our great nation in recent years. It seems that the various activists movements and politics-for-politicians-sake way of government has resulted in adverse effects to our national financial and physical well-being. For example, the national debt is now several trillion dollars and growing, and the past few decades, according to the statistics from the National Institutes of Health and Centers for Disease Control confirms that on average our population is becoming a nation of obese, sickly, prescription drug-dependent weaklings. The way this nation is being run is an absolute insult and injustice to people like you and me who are working hard to be their best in health and life. If you agree, perhaps it is time to let the world hear the voice of the physically fit and mentally strong, and organize a trip to Washington, D.C. for a demonstration to let everybody know about how the bodybuilding lifestyle is the best for building strong citizens and strong nation. I think Ben Weider said it best in a statement that appears on his IFBB letterhead: Bodybuilding is Important for Nation Building. If you are interested in really flexing some muscle for a stronger and healthier U.S.A., then let us know you want to take a trip to D.C., and if the interest is big as we think in can be, we will get back to you about the next step for organizing a demonstration of fit Americans to let the politicians and media know it is time to get tough again and support the way of life that made this nation the greatest place in the world in the first place. In the meantime, let your Congressman and Senators know that you oppose DSAA if you want to preserve free access to a wide selection of affordable dietary supplements.
Send Your E-mails To Congress NOW!
Click Here ( http://capwiz.com/nnfa/mail/oneclick_compose/?alertid=7879031 )
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