It is time again to flex some Bodybuilding.com community muscle like we did in support of Arnold earlier this year. But this time we need to let our politicians know, ENOUGH ALREADY, and to leave our dietary supplements alone.
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A Political Screw Ball
There has been much confusion in the media and articles about how the Codex and the European Directive on Nutritional Supplements might affect sales of dietary supplements in the U.S.A. To reiterate what I previously covered in other articles, these regulations do not affect the sales of dietary supplements in the U.S.A.
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.
DSHEA (Dietary Supplement Heath and Education Act)
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.
- The U.S. Food and Drug Administration (FDA) today announced a permanent injunction shutting down operations at Pharmakon Labs of Florida. The company manufactured and distributed cough and cold liquids, tablets and caplets. Following inspections by FDA and a trial in U.S. District Court, Judge Richard A. Lazzara found that drug products sold by Pharmakon Labs, Inc., its president Abelardo L. Acebo, and its secretary/treasurer Edward R. Jackson (the defendants) did not meet current good manufacturing practice (cGMP) standards and other legal requirements.
- The U.S. Food and Drug Administration (FDA) is announcing that Baxter Healthcare Corporation of Deerfield, Ill., has initiated a worldwide recall of all models of its Colleague Volumetric Infusion Pumps because they can shut down while delivering critical medication and fluids to patients. Baxter has received six reports of serious injury and three reports of death associated with this shut-down problem. The affected are: Models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.
- The U.S. Food and Drug Administration (FDA) is issuing a Safety Alert to consumers about the recall of SMOKED SALMON SKINLESS SLICED SIDES packaged in various 2 to 4 lb. weight packages because they may be contaminated with Listeria monocytogenes.
- Beaverton Foods, Inc. of Hillsboro, Oregon is recalling Inglehoffer Wasabi Horseradish Code N172, because the labeling may not declare the eggs, Metabisulfite and Yellow No.5 contained in the product. People who have an allergy or severe sensitivity to eggs, sulfites and/or Yellow No.5 run the risk of serious or life-threatening allergic reaction if they consume this limited mislabeled product.
- The Food and Drug Administration (FDA) is investigating recently reported serious adverse events associated with mifepristone (trade name Mifeprex, also known as RU-486). As a result, the FDA is issuing a public health advisory today highlighting the risk of sepsis or blood infection when undergoing medical abortion using Mifeprex and misoprostol in a manner that is not consistent with the approved labeling. There are now four cases of deaths from infection from September 2003 to June 2005 following medical abortion with these drugs.
- Nabisco Foods, a Kraft Foods company of East Hanover, NJ, is recalling approximately 838,000 of the 7.5 oz. boxes of Pure Milk Chocolate Covered Oreo Sandwich Cookies with the UPC product code number of 44000 01094 and Best When Used By dates through 05NOV05 because some boxes may contain cookies with peanut butter crÃƒÆ'?Ãƒâ€ 'ÃƒÆ'Ã¢â‚¬Å¡Ãƒâ€šÃ‚Â¨me filling, rather than the vanilla crÃƒÆ'?Ãƒâ€ 'ÃƒÆ'Ã¢â‚¬Å¡Ãƒâ€šÃ‚Â¨me filling depicted on the front label. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.
- The FDA today issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. In addition, a patient information sheet and an alert to healthcare professionals were issued identifying several important safety precautions for the use of fentanyl transdermal patches. These safety precautions include but are not limited to patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal. The FDA is conducting an investigation into the deaths associated with these patches. The Agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use. The Agency is working closely with the manufacturers of fentanyl patches to fully evaluate the risks associated with their use and to develop a plan to help patients avoid accidental fentanyl overdose.
- Lappert's Ice Cream of Richmond California is recalling its Banana Caramel Chocolate Chip Ice Cream, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and other with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages, and stillbirths among pregnant women.
- McNeil Consumer & Specialty Pharmaceuticals is voluntarily recalling all lots and all flavors of Children's TYLENOL Meltaways 80 mg packaged in bottles and blisters, Children's TYLENOLSoftChews 80mg packaged in blisters, and Junior TYLENOL Meltaways 160mg packaged in blisters. The blister package design, as well as the information on the blister package and on the blister and bottle cartons may be confusing and could lead to improper dosing, including over-dosing.
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 agency has issued a Consumer Advisory and sent updated letters to industry and health professionals to communicate our concern about the use and marketing of dietary supplements or other botanical-containing products that may contain aristolochic acid. The use of products containing aristolochic acid, including botanical products marketed as traditional medicines, has been associated with nephropathy. Because of our concerns about botanical-containing products known or suspected to contain aristolochic acid, we will be pursuing appropriate regulatory action regarding these products.
- The Food and Drug Administration is warning consumers not to purchase or consume the product Triax Metabolic Accelerator, containing the active ingredient tiratricol. The product is being marketed as a dietary supplement for weight-loss purposes by Syntrax Innovations, Inc., of Cape Girardeau, Missouri. FDA has determined, however, that this product is not a dietary supplement but an unapproved new drug containing a potent thyroid hormone, which may cause serious health consequences including heart attacks and strokes. The chemical name for the active ingredient in the product is triiodothyroacetic acid (TRIAC). Through its MedWatch reporting system, FDA has recently learned of several individuals who were found to have abnormal thyroid function test results while using Triax. These individuals had sought medical attention because of symptoms such as severe diarrhea, fatigue, lethargy or profound weight loss. FDA is aware that this product is being sold through retail establishments and on the internet. The agency urges all individuals who may have purchased this product or any other product containing TRIAC to stop using it immediately and, in addition, to consult their health care professional if they are experiencing any adverse effects, which may include insomnia, nervousness, sweating and diarrhea. The State of Missouri has embargoed this product at its distributor, an action that prevents the firm from releasing for sale the supply it has on-hand. FDA has also contacted Pharmatech of Linden, Utah, the firm who manufactured the product Triax. Pharmatech has agreed to stop distributing any product containing the ingredient TRIAC. Further action by the U.S. Food and Drug Administration is being considered [Note: in this instance the product was not legally a dietary supplement, but a drug being sold as a dietary supplement. But in the end the current MedWatch reporting system and FDA authority was adequate to take appropriate actions.]
- Consumers were warned to stop using the dietary supplement / herbal products PC SPES and SPES capsules because they contain undeclared prescription drug ingredients that could cause serious health effects if not taken under medical supervision. Laboratory analysis of the products by the California Department of Health Services found PC SPES contains warfarin and SPES contains alprazolam. Warfarin and alprazolam are available only by prescription and sold either by their generic names or the trade names, Coumadin and Xanax. PC SPES and SPES are respectively marketed "for prostate health" and strengthening the immune system. BotanicLab, the manufacturer of the products, voluntarily recalled PC SPES and SPES nationwide. [Note: in this instance the product contained a drug ingredient being sold as a dietary supplement.]
- FDA is alerting the public about Chinese weight-loss products, Chaso (Jianfei) Diet Capsules and Chaso Genpi, because they pose a potential public health risk. The agency is alerting the public to this health risk because several people in Japan have become ill, and some have died, after consuming these diet products. "FDA is taking this action as a precautionary measure to help assure that people are not exposed to this potentially dangerous product," said Dr. Lester M. Crawford, FDA Deputy Commissioner. Products of this type are often sold in small urban markets as alternatives to Western medicine. In 2001, FDA issued a nationwide alert on the recall of thirteen "Treasure of the East" herbal products because of a dangerous ingredient, aristolochic acid, which is toxic to the kidney. The deaths in Japan linked to these Chinese weight-loss products may have resulted from the presence of such active drug ingredients as fenfluramine in the capsules. Fenfluramine and another diet drug, phentermine, were used in combination for weight loss until it was determined that the combination of drugs was linked to valvulopathy, a serious and sometimes fatal heart disease. Fenfluramine and a chemically similar drug, dexfenfluramine, were removed from the market in 1997. Phentermine, when used alone, has not been associated with valvulopathy and remains on the market. FDA has advised its import operations personnel to be on the alert for Chaso Diet Capsules and Chaso Genpi. The agency is urging consumers not to take these diet pills and to notify their local FDA if the products are found in their area. [Note: this is another example of how FDA has the authority and ability to remove potentially harmful products or products that do not contain legal ingredients, and is also an example of what was referred to as a dietary supplement actually being a product containing banned drugs.]
When you sort through the research and FDA actions against suspected dietary supplements, it turns out that authentic dietary supplements are rarely if ever suspect. In fact the most prevalent health concern with dietary supplements involves children eating multivitamins and mineral supplements that contain iron. This is why iron containing supplements are required to use child safety caps or other special packaging depending on how much iron a particular supplement contains. In one year more harm occurs from this then in the history of all other dietary supplement incidences lumped together. Yet, this issue is not even mentioned in the proposed DSAA, in fact mineral containing supplements, like iron supplements were exempt from the proposed DSAA.
The required warning for iron containing products is:
Dietary supplements containing iron or iron salts. (1) The labeling of any dietary supplement in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts for use as an iron source shall bear the following statement:
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.
Leave Well Enough Alone, DSHEA Works Best
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.
Aside: do you know that the department of Health and Human Services spent millions of our tax payer dollars to review all the research about SAMe (S-Adenosyl-L-Methionine) and published their findings in a report. In this report, the experts concluded that SAMe is as or more effective and safer than drugs for the treatment and management of diseases like depression and osteoarthritis, and certain liver diseases. Every doctor, nutritionist, health practitioner and person inflicted with these diseases should know about this and start taking SAMe. This should be national news. But instead, probably a small number of people read the report and know about it; unbelievable!
You can read the report online at:
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.
7.40 - Recall policy.
§ 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
101.1 - Principal display panel of package form food.
§ 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
101.22 - Foods; labeling of spices, flavorings, colorings and chemical preservatives.
§ 101.30 - Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice.
101.36 - Nutrition labeling of dietary supplements.
§ 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
101.54 - Nutrient content claims for good source, high, more, and high potency.
§ 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
101.70 - Petitions 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).
Subpart A -- General Provisions
110.3 - Definitions.
§ 110.5 - Current good manufacturing practice.
§ 110.10 - Personnel.
§ 110.19 - Exclusions.
Subpart B -- Buildings and Facilities
110.20 - Plant and grounds.
§ 110.35 - Sanitary operations.
§ 110.37 - Sanitary facilities and controls.
Subpart C -- Equipment
110.40 - Equipment and utensils.
Subpart D [Reserved]
Subpart E -- Production and Process Controls
Subpart F [Reserved]
Subpart G -- Defect Action Levels
110.110 - Natural or unavoidable defects in food for human use that present no health hazard.
DSAA (Dietary Supplement Access and Awareness Act)
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.
Dietary Supplement Access and Awareness Act (Introduced in House)
View The Bill Here.
Some Points About the Proposed DSAA
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:
- Food and food additives for man or animals
- Dietary supplements and dietary ingredients
- Infant formula
- Beverages (including alcoholic beverages and bottled water)
- Fruits and vegetables
- Fish and seafood
- Dairy products and shell eggs
- Raw agricultural commodities for use as food or components of food
- Canned foods
- Live food animals
- Bakery goods, snack food, and candy
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 An Excellent Safety Record.
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.
Lets Go To Washington D.C. And Let Politicians Know The Bodybuilding Lifestyle Is What Works Best.
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.
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