Microsoft word - 2012 memo re nutritional and dietary supplements.docx
M E M O R A N D U M
All Players covered under Major League Baseball’s Drug Programs are urged to use only
supplements that have been certified under the NSF Certified for Sport program. The list of NSF Certified for Sport products is available at www.NSFsport.com. The use of any nutritional or dietary supplement that has not been certified under the NSF Certified for Sport program carries the risk of a positive test under MLB’s Drug Programs.
Because the supplement industry is not subject to stringent government regulation, even
supplements sold over-the-counter at national retail chains such as GNC and Vitamin Shoppe have been found to be contaminated or contain unlisted ingredients that have caused positive drug tests. A non-exclusive list of potentially contaminated nutritional supplements is attached to this memorandum.
There are most likely numerous other products available for purchase in retail establishments or
over the internet that may cause a positive test. Unfortunately, we typically learn that a supplement contains a prohibited substance after
a Player who used it tests positive. Unless the specific bottle of supplements that you desire to consume is subject to expensive laboratory testing, no one can provide you with a guarantee that a non-NSF Certified for Sport supplement does not contain a Prohibited Substance. As a result, we urge you to only consume supplements that have been NSF Certified for Sport.
Under MLB’s Drug Programs, you are responsible for the substances you put into your body. If
you have any questions regarding supplements, you should contact:
Bryan King (40 man roster only) & Donovan Santas (non-40 man roster) – We have designated
Bryan King and Donovan Santas as the persons at our Club that you should contact if you have any questions regarding supplements. If you prefer, Dr. Fischer is always available to answer any questions that you may have.
Joint Strength and Conditioning Coordinator (Tim Maxey, 216-272-2153).
Major League Baseball Players Association (Bob Lenaghan, 212-826-0808) (Players only).
Office of the Commissioner (Jon Coyles, 212-931-7859) (Club personnel only).
If you do choose to take any supplements that have not been certified by NSF, you do so at your
Non-Exclusive List of Potentially Contaminated Nutritional Supplements (Attachment 2)
The following nutritional supplement products available for over-the-counter or online purchase may contain
Prohibited Substances not listed on the label or may cause a positive drug test.
1-Androsterone (Advanced Muscle Science)
AmphetaLean Extreme (Beast Sports Nutrition)
Trinoble Anabolic Stimulator (Hyper Trop-
Muscle Speed (Accelerated Nutraceuticals)
Finaflex 550-XD or Finaflex Ripped (Redefine
Forged Extreme Mass or Lean Mass (Transform
Any products that contain:
, Geranium Oil
* * Androstenetrione
or 4-etioallocholen-3,6, 17-trione
, 4,9-estradiene-3, 17-dione
, 19-norandrosta 4,9-diene-3,17-dione,
or Bovine Colostrum
*Any products that claim to Increase Testosterone
or Suppress Estrogen
*Weight Loss Supplements and Diet Pills (See www.FDA.gov
for more information)*
Just because a product is not on this list DOES NOT MEAN IT IS SAFE. Numerous other products available
for purchase may cause a positive drug test or be contaminated. We urge you to only use supplements that
are NSF CERTIFIED FOR SPORT.
FDA: Tainted products marketed as dietary supplements potentially dangerous
Agency working with trade associations to increase company vigilance and protect public
In a letter sent today to dietary supplement manufacturers, the U.S. Food and Drug Administration expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements. These substances include the active ingredients in FDA-approved drugs or their analogs (closely-related drugs), or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients. In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products. The FDA’s letter emphasizes that manufacturers and distributors are responsible for ensuring that their products comply with the law. Five major trade associations – Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance, Consumer Healthcare Products Association and American Herbal Products Association– are joining FDA on a call for media and have agreed to share the letter widely within the industry. "These tainted products can cause serious adverse effects, including strokes, organ failure, and death," said FDA Commissioner Margaret A. Hamburg, M.D. "The manufacturers selling these tainted products are operating outside the law." The FDA is seeking input and col aboration from dietary supplement trade associations to educate the industry about this problem and to help develop new strategies to combat it, according to Hamburg. The agency also announced a new RSS feed to warn consumers more quickly about tainted products marketed as dietary supplements. The FDA has noted the three most common categories of these illegal products:
Weight loss products containing active ingredients such as sibutramine: Sibutramine is the active ingredient
in the drug Merida, which was recently withdrawn from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty, Solo Slim, Slim-30, and others, which contain sibutramine or closely related drugs (analogs).
Body-building products containing anabolic steroids or steroid analogs: These products can cause acute
liver injury and increase the risk for heart attack, stroke and death. Products like Tren Xtreme, ArimaDex, and Clomed have been labeled to contain either anabolic steroids or aromatase inhibitors, which prevent anabolic steroids from being converted to estrogen.
Sexual enhancement products that contain the same active ingredient or an analog of the active ingredient
in the approved drugs Viagra, Cialis, and Levitra. The approved products are available only by prescription, and they should not be used by people who have certain medical conditions, such as cardiovascular disease. Products determined to be in violation of federal law by the FDA include Vigor-25, Duro Extend Capsules for Men, Magic Power Coffee, and others.
"The labeling of these tainted products may claim that they are 'alternatives' to FDA-approved drugs, or 'legal' alternatives to anabolic steroids," said Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research. "Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails." Companies that make or distribute tainted products may receive warning letters and/or face enforcement actions such as product seizures, injunctions, and criminal prosecution. Responsible individuals may also face criminal prosecution. Lawful dietary supplements contain minerals, vitamins or other dietary ingredients and are intended to be an addition to a standard diet. The FDA regulates these products under the Dietary Supplement Health and Education Act, passed by Congress in 1994. Unlike drugs, dietary supplements do not have to be approved by the FDA prior to
marketing. Dietary supplement manufacturers and distributors are responsible for selling a safe product. FDA’s Current Good Manufacturing Practices require dietary supplement manufacturers to have proper manufacturing and quality assurance controls in place to ensure the quality of their products, including controls to prevent the inclusion of contaminants that could adulterate their products.
FDA Expands Warning to Consumers About Tainted Weight Loss Pills
The U.S. Food and Drug Administration is expanding its nationwide alert to consumers about tainted weight loss pil s that contain undeclared, active pharmaceutical ingredients. On December 22, 2008, FDA warned consumers not to purchase or consume 28 different products marketed for weight loss. Since that time, FDA analysis has identified 41 more tainted weight loss products that may put consumers’ health at risk. The tainted weight loss products are:
An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent) and bumetanide (a diuretic). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers' health at risk. These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are il egal and may be potential y harmful to consumers. The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately. The FDA encourages consumers to seek guidance from a healthcare professional before purchasing weight loss products. “These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.” The FDA has inspected a number of companies associated with the sale of these il egal products, and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recal requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges. The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia (rapid heart beat), palpitations, heart attack or stroke. This drug can also interact with other medications and increase their risk of adverse drug events.
Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the U.S. The drug has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years.
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