By James J. Gormley
Courtesy of the SupplySide Community
On April 24th, the U.S. Food and Drug Administration (FDA) sent warning letters to 10 companies cautioning them, in the strictest possible terms, that their DMAA (1,3 Dimethylamylamine)-containing products may be considered new dietary ingredients for which notifications have not been submitted and, so, would be adulterated products in violation of law and subject to seizure.
And, oh, by the way, since DMAA is a synthetic version of what may or may not be a constituent in geranium, it could not even be an NDI if it wanted to be, according to the FDA.
The FDA is resting its very, very shaky case on a false premise, or misguided hope, that DMAA is not found in geranium and that synthetic analogues of naturally occurring consumables would never qualify as a dietary ingredient. This willful misinterpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) comes directly from the FDA’s NDI Draft Guidance.
For the FDA to assert that no synthesized natural compound could ever be a dietary supplement is tantamount to saying that the vast majority of all dietary supplement products on the market today are adulterated.
Most dietary supplements on the market today contain synthetic analogues of naturally occurring natural ingredients, including vitamin C, alpha lipoic acid, and various amino acids.
In truth, DMAA is a constituent of the geranium (Pelargonium graveolens) plant, having been identified in the oil obtained from the steam distillation of the stems and leaves. This DMAA-containing plant has been used for centuries as a food item (e.g., leaves are infused for teas and added to desserts and confections, flowers are used in salads, while the oil has been used as a flavoring agent). In fact, the geranium plant and its oil are generally recognized as safe (GRAS). In terms of safety, GNC, for example, has sold 440 million servings of DMAA since 2007, with only one reported adverse event.
The FDA is following on the heels of the Defense Logistics Agency, which took products containing DMAA off military base shelves earlier this year based on two cases of death anecdotally linked to DMAA—despite the fact that the Pentagon has acknowledged no link between DMAA and the soldiers’ deaths.
On September 6th, 2011, Barry Lynch from Cantox Health Sciences International issued an open memo in which he stated that not only do published data already exist (Ping et al., 1996) confirming that DMAA does occur in geranium oil, but also that USPlabs (the maker of Jack3d) has obtained new data “from two independent and highly respected analytical chemistry laboratories, utilizing advanced validated […] instrumentation and methods, [that] corroborate the original data published by Ping et al., and further demonstrate the occurrence of DMAA in the geranium plant […] and its edible oil.”
To be clear, the FDA is outrageously overstepping its bounds by using (although not overtly citing) non-binding opinion from a draft guidance document in Warning Letters in order to not only scare the named companies from using DMAA any longer but to also cause a widespread chilling effect in the marketplace where gun-shy companies preemptively pull an ingredient that is attracting the FDA’s attention rather than go to bat for it or join with other companies that are.
We see this happening already. Even companies that did not receive a Warning Letter are reformulating or have already reformulated their products into non-DMAA alternatives.
This is exactly what the FDA wants. Use inexpensive Warning Letters (as opposed to attempting to drag companies into Federal Court or to actually prove anything, which it cannot) to frighten the marketplace into “complying” with a version of the law that the Agency wished were in place but is not.
But no matter, if the industry decides that is much easier, and safer, to just sacrifice DMAA to avoid nasty letters from the FDA and to shield itself from frivolous class-action lawsuits citing non-binding Warning Letters, then it will have conceded defeat without a live bullet having even been fired.
And this is not to be critical of industry firms either, which honestly need to balance legal and regulatory exposure with the perceived or actual value of keeping a now-controversial ingredient in products, not to even mention public companies’ shareholder concerns and jittery insurance company worries.
That being said, the whole ugly mess reminds me of the early years in our current millennium when ephedra’s neck was on the proverbial chopping block. Many of us testified on behalf of this wonderful master botanical and tried to enlist the aid of an ephedra council from which the members had fled as if from a burning house—the San Diego ephedrine scandal did not help things, to put it mildly.
Now we have an ingredient on the chopping block.
It may not be a master herb with thousands of years of traditional use. It is not a full-spectrum botanical. And it has been included in some products whose marketing is not what we would hold up as a shining example of advertising probity and conservatism. But it does represent a line in the sand drawn by the FDA.
If we were to fully cave on DMAA, the FDA will use this as precedent for establishing a beach head on the shore of “nothing synthetic can be an NDI,” and then where will we be and what will we have gained—or lost?
Tags: CFH, dietary supplements, DMAA, DSHEA, FDA, geranium, GNC, James Gormley, justin prochnow, NDI, steven shapiro, the gormley files
QUESTION: Why is it that heart disease seems to affect more women than men?
Dr. Eric Ding
DR. DING: There are certain social differences as well as inherent biological differences. However, there is need for clarification about the gender difference in heart disease…. Although women have fewer heart attacks than men, women are more likely to die of heart attacks than men. Part of it is differences in diet and lifestyle (e.g., men eat often more red meat and saturated fat), but also that women’s heart attacks are often less obvious, such as the fewer overt chest pains at onset of heart attacks compared to men. Additionally, women also perceive a lower risk of heart attacks than they actually have, which decreases their chance of seeing the doctor. Moreover, even if a woman knows she has heart disease and sees a doctor, research has shown that women (compared to men) are less likely to receive ECGs, less likely to get angiograms, less likely to get bypass and stent procedures, and less likely to receive cholesterol-lowering medications. Moreover, biologically, drugs like aspirin that strongly prevent heart attacks in men, are less effective against heart attacks in women. And finally, a woman with diabetes is more likely to die of heart disease than a similar man with diabetes. Altogether, these all lead to higher heart disease mortality for women than men.
QUESTION: What are the most important things a woman can do to decrease her chances of heart disease?
DR. DING: Exercise regularly (30 minutes a day), maintain an optimal BMI of 18.5-25 and don’t smoke.
I rank sugar sweetened beverages (SSBs) as one of the worst causes of heart disease. It’s not the sugar per se, but rather liquid sugar intake such as in soda and sweetened juices, because liquid sugar is partially “invisible“ to our hunger control system. Indeed, the difference between liquid sugar and solid sugar is best seen in an experiment between sugary beverages vs. jelly beans (with same number of calories). While jelly bean eaters become full and ate less food later in the day, liquid sugar drinkers were not fully satiated and become hungrier sooner and consumed more calories at the end of the day (compared to solid sugar eaters).
This is why sugary beverages (but not sugar) are inherently dangerous (read my recent piece for more info: http://www.huffingtonpost.com/eric-ding-phd/sugary-beverages-harmful-effects_b_1103758.htm). For the same reason, parents should not give too much SSB to their children.
Inadequate intake of fruits and vegetables is another major cause of heart disease in America. Only a small segment of the population gets 5 servings of fruits and veggies a day — and this actually includes French fries, which nutritionists don’t really consider a vegetable [But how did the starch French fries get classified as vegetable by the USDA? It's not hard to imagine what industry group had successfully lobbied the USDA for the 'French fry' vegetable classification!].
Cocoa flavonoids are good against heart disease: from multiple systematic reviews of dozens of randomized trials, cocoa flavonoids are shown to lower BP, lower bad LDL, raise good HDL, improve insulin sensitivity, and improve blood flow. Recent reviews of multiple long-term cohort studies have also shown benefits of cocoa for lowering heart disease. However, interestingly, the benefits in the trials were observed with doses of around 400-500 mg/day, equivalent to 33 bars of milk chocolate or 8 bars of dark chocolate. Thus, because it is unreasonable to consume all the calories, sugar and fat to achieve these levels of cocoa flavonoids through just chocolate bars alone… supplements with concentrated cocoa flavonoids are helpful for garnering the benefits discovered (supplements available commercially, e.g. CocoaWell supplements in 400 mg. dosage). The key is getting the benefits of cocoa flavonoids for heart disease while avoiding the calories, and for that, chocolate bars are not the solution – supplements are a better option.
Additionally, beyond SSBs and French fries, generally, high glycemic load refined starches are a cause of heart disease. Therefore look for whole grains instead of white bread, brown rice instead of white rice, and steel cut oats instead of instant oatmeal. And avoid mashed and baked potatoes, which have an incredibly high glycemic index and glycemic load, equivalent to almost pure table sugar in spiking one’s blood sugar (and elevating heart disease risk).
Avoid trans-fats at all cost. Many years ago, before the nutrition and medical community realized the dangers, the emphasis had been on avoiding butter — and instead people were recommended to consume margarine instead. However, the Department of Nutrition at Harvard School of Public Health discovered that trans-fats, high in margarine sticks, were even worse than the saturated fat in butter for increasing heart disease risk. This eventually led to trans-fat bans from restaurants in NYC, and then the rest of the country. Trans-fats are inherently bad for both their ability to increase bad LDL cholesterol, lower good HDL cholesterol, and increase inflammation – all of which increase heart disease substantially.
QUESTION: Is heart disease hereditary?
DR. DING: Only partly hereditary – while over 80% is preventable. As shown in several large studies at Harvard, a combination of lifestyle factors can prevent 82% of heart disease and 90% of diabetes (a major cause of heart disease mortality).
QUESTION: Can you offer any health studies on natural products/dietary supplements and their proven benefits for Heart/Cardiovascular health?
DR. DING: Emerging studies and systematic reviews suggest that:
–Vitamin D may hold promise not only for cancers but also for prevention of coronary heart disease. As well as potentially diabetes.
–As noted earlier, cocoa flavonoids, from multiple systematic reviews of dozens of randomized trials, are showing great heart health results. See information above re supplements like CocoaWell.
–Niacin lowers bad LDL, but it causes flushing.
–Potassium supplements strongly lower BP, but be careful of overdosing.
–Folic acid among LOW folate individuals may lower stroke risk, but folate is not beneficial in most people, since the US now has folate fortification in most grain products.
–Magnesium may modestly improve glucose and lower CVD risk.
–Algal oil supplement was shown in a recent meta analysis to lower triglycerides and raise HDL, but it slightly increased LDL.
–Grapefruit enhances the effects of Cholesterol lowering statin medications, effectively requiring less meds to achieve same effects at lower drug dose. But one should inquire with your doctor. And don’t ever drink alcohol with grapefruit.
QUESTION: What research are you currently working on? What kinds of research projects would you most like to do?
DR. DING: I believe in the importance of evidence-based translational medicine…there is so much fluff and false claims in the nutrition world that I want to make sure all claims are justified with a strong body of consistently supported scientific evidence. That is why I enjoy conducting large systematic reviews and meta-analysis (which I have taught at Harvard for the last 6 years). I’m an epidemiologist and nutritionist – so I like to focus on evidence based medicine in the realm of disease prevention… because an ounce of prevention is worth a pound of cure.
Tags: cocoa flavonoids, eric ding, heart disease, sugar sweetened beverages
New National Survey Shows Majority of Americans United
on Labeling of Genetically Engineered Food
Media contact: Sue McGovern sue@mcgov.com Direct: 781-648-7157 Cell: 781-315-3400Washington, D.C. (March 27, 2012) – The Just Label It (JLI) Campaign announced today that a record-breaking one million Americans of all political persuasions have called on the FDA to label genetically engineered (GE) foods. The campaign also announced a new national survey revealing that Americans across the political spectrum stand united in support of labeling food that has been genetically engineered. This is a striking contrast to the partisan divisions plaguing our political system.
“Pink slime, deadly melons, tainted turkeys, and BPA in our soup have put us all on notice that what we eat and feed our families is critically important,” said Ken Cook, President of the Environmental Working Group, a JLI partner. “Americans overwhelmingly demand safety, transparency and labeling of genetically engineered foods. It’s time for the FDA to come clean and restore public confidence in our food system.”
Since October, JLI, (www.justlabelit.org), the national campaign to require GE-food labeling and its more than 500 partner organizations have spearheaded an historic number of public comments for a GE-foods labeling petition (Docket #FDA 2011-P-0723-001/CP). March 27 is the date when the FDA is required to respond to the petition. It took less than 180 days to accumulate the record number of comments.
“In recent years, Americans have shown a real interest in knowing more about our food and now there is a clear mandate for the labeling of genetically engineered foods. This petition asks the FDA to stand up for the rights of average Americans, and not just a handful of powerful chemical companies. It’s time for the FDA to give Americans the same rights held by citizens in forty nations, including all of our major trade partners, to know whether our foods have been genetically modified. The FDA needs to restore confidence in our food and our right to know about the food we eat and feed our families,” said Gary Hirshberg, chairman of Stonyfield, a JLI partner.
New Survey Results: Motherhood, Apple Pie and GE Food Labeling
Consumer support for GE-foods labeling in the U.S. is nearly unanimous, according to the political opinion survey on GE food labeling conducted by The Mellman Group on behalf of JLI. Explained pollster Mark Mellman, “Few topics other than motherhood and apple pie can muster over 90 percent support, but labeling GE-foods is one of those few views held almost unanimously.” “The survey found nearly all Democrats (93% favor, 2% oppose), Independents (90% favor, 5% oppose) and Republicans (89% favor, 5% oppose) in favor of labeling. The study also revealed that support for labeling is robust and arguments against it have little sway. (For the survey findings, visit www.justlabelit.org)
Colorado mother and author Robyn O’Brien, who founded the AllergyKids Foundation, a JLI partner, after one of her children had an allergic reaction to breakfast, said: “Americans are responding to the call for GE foods labeling because they want more information for their families. Like allergen labeling, GE-food labels would provide essential and possibly life-saving information for anyone with a food allergy. Being responsible for the health and safety of my children, I believe it’s my right to know about the food I feed my family…from allergens, to ‘pink slime’ to GE foods.”
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About Just Label It
JUST LABEL IT (JLI) is a national coalition of 500 diverse organizations dedicated to the mandatory labeling of genetically engineered (GE) foods, also referred to as genetically modified, or GMOs. The Just Label It message is simple: consumers have a right to know about our food so we can make informed choices about what we eat and feed our families. For updated information, visit the Just Label It website, (www.justlabelit.org)
What is a GMO?
“Genetically engineered foods,” “genetically modified organisms,” or GMOs, are organisms that have been created through application of transgenic, gene-splicing techniques that are part of biotechnology. This relatively new science allows DNA (genetic material) from one species to be transferred into another species, creating transgenic organisms with combinations of genes from plants, animals, bacteria, and even viral gene pools. The mixing of genes from different species that have never shared genes in the past is what makes GMOs and GE crops so unique. It is impossible to create such transgenic organisms through traditional crossbreeding methods.
Tags: CFH, Citizens for health, Corporate Ugliness, FDA, food labeling, food safety
Washington, D.C. — At the end of last year, the Defense Logistics Agency (DLA) – the military’s largest logistics combat support agency – issued a notification prohibiting The Army and Air Force Exchange Service, as well as GNC retail stores located on military bases, from selling dietary supplements that contain 1,3-dimethylamylamine (DMAA). This action was taken following the deaths of two soldiers who purportedly used DMAA-containing dietary supplements, even though the Department of Defense has acknowledged that a link between DMAA and the medical conditions reported has not been established.
Citizens for Health understands the Department of Defense’s desire to protect the health and safety of our military personnel. However, the answer is not to pull legally-marketed products from shelves before an investigation has been conducted to determine whether DMAA-containing products caused or contributed to the medical complications experienced by the soldiers. Rather, DLA made the premature and unsubstantiated decision to ban the sale of DMAA-containing products on its bases, based largely on media reports fueled by competitive interests. While an investigation is currently pending, DLA’s notification currently lacks scientific support and deals with issues that do not properly fall under its jurisdiction.
DMAA-containing dietary supplements are legally sold in the United States and regulated by the U.S. Food and Drug Administration. FDA’s stringent requirements – including the Dietary Supplement Health and Education Act of 1994, the Nutrition Labeling and Education Act of 1990, good manufacturing practice regulations, and the Fair Packaging and Labeling Act – ensure the safety of dietary supplements.
Moreover, the safety of these products is independently supported by several peer-reviewed scientific studies, which the makers of products containing DMAA have made publicly available. Given the foregoing, we question why DLA’s notification was issued in the first place. The only thing DLA has done is needlessly interfere with the consumer’s right to purchase legal dietary supplements.
Such rights should not be infringed by DLA, especially in the absence of scientific evidence demonstrating a causal link between consumption of DMAA and medical complications. Citizens for Health calls on the Department of Defense to immediately rescind DLA’s notification and reinstate military personnel access to DMAA-containing products.
In the coming weeks, we will provide further updates as this situation unfolds. In the interim, Citizens for Health asks you to join us, the health freedom community, and concerned Americans everywhere in the campaign to get DLA’s notification rescinded and the free enterprise system restored on military bases.
If you agree that the Department of Defense should not interfere with military consumers’ right to purchase lawful dietary supplements, sign our petition now!
Tags: defense logistics agency, department of defense, DLA, DMAA, DOD, GNC, NLEA
Dr. Julian Whitaker
By Julian Whitaker MD
Do you get intense carbohydrate cravings? Are there times when you just have to have a snack or can’t resist a cookie? These cravings are not just a road to an expanding waistline – they are also a warning sign. Carbohydrate cravings are often associated with insulin resistance, which in turn is a precursor to type 2 diabetes.
In individuals who have insulin resistance, the beta cells in the pancreas make plenty of insulin – the hormone that moves glucose from the blood into the cells – but the cells are unresponsive to insulin’s actions, leading to a rise in blood sugar. The pancreas responds by churning out more insulin, but it may overshoot the mark, driving blood sugar too low and creating an immediate demand for more glucose. This often manifests as carbohydrate cravings.
Unfortunately, when you heed the call, a vicious cycle is set into motion. More glucose demands more insulin, and over time, your body’s blood sugar-regulating mechanisms cannot keep up and signs of insulin resistance become more prominent.
Part of the problem is that chronically elevated levels of insulin, which are characteristic of insulin resistance, promote weight gain. That’s because insulin is the body’s primary fat-storage hormone – it ushers fat as well as glucose into the cells. So the higher your insulin level, the greater your potential weight gain.
To make matters worse, obesity throws fuel on the fire. Adipose tissue (fat), especially in the abdominal area, releases fatty acids that impair beta-cell function and insulin sensitivity, as well as immune cells that lead to chronic, low-grade inflammation. Inflammation, in turn, increases insulin resistance and risk of diabetes.
The answer to the problem is to interrupt this insidious cycle as early as possible. Start with your diet. Sweets, potatoes, bread, pasta, and most everything made with sugar or refined grains – think white foods – have a high glycemic index and load. This means they rapidly drive up blood glucose but may be followed a couple of hours later by reactive hypoglycemia, a compensatory blood sugar dive that makes you tired, sluggish, and so hungry you feel like you could eat anything in sight.
To avoid this very common phenomenon, eat more fiber-rich vegetables and beans and include some protein with every meal. These foods are not only bulky, filling, and lower in calories, but because they cause a gradual rise in blood sugar, they’ll keep you going longer and are less apt to stimulate food cravings.
There are also some interesting supplements that can help control cravings. One of them is saffron, a bright yellow culinary spice that has been used in traditional medicine to tame inflammation and ease digestive woes. Saffron helps raise levels of serotonin, a neurotransmitter that boosts mood, influences hunger and satiety, and helps put the brakes on food cravings – especially for carbohydrates. This makes saffron a real boon for people trying to lose weight.
Look for saffron supplements in your health food store. You can also purchase my Saffron Snack Stopper by visiting www.drwhitaker.com or by calling 800-722-8008. Aim for the study dosage of 90 mg twice a day with meals. Note: It can take up to four weeks to see results, so be patient.
Another supplement for carb cravings is 5-hydroxytryptophan (5-HTP). A direct precursor to serotonin, 5-HTP boosts levels of this important neurotransmitter and helps curb carb cravings. This supplement is particularly helpful for people with hormonal imbalances and those eating low-calorie diets, particularly low-protein diets, which may not provide enough of the amino acids required for serotonin production. The suggested dose is 50 to 100 mg, taken between meals. Do not take 5-HTP if you are on an SSRI antidepressant.
The most important tool for reversing insulin resistance (and potential diabetes) is weight loss, and reducing cravings is an important step toward that end. So stock up on fiber-rich foods, eat protein at every meal, and try supplemental saffron and 5-HTP, and you just may be able to keep carbohydrate binges at bay.
About Dr. Whitaker. Dr. Whitaker is Director of the Whitaker Wellness Institute and Editor of Health and Healing newsletter that provides important health advice for more than 500,000 people nationwide. Dr. Whitaker graduated from Dartmouth College in 1966 and received his MD in 1970 from Emory University Medical School. He completed his surgical internship at Grady Memorial Hospital in 1971, and continued at the University of California in San Francisco in orthopedic surgery. In 1974, Dr. Whitaker founded the California Orthomolecular Medical Society, along with four other physicians and the Nobel prize-winning scientist Dr. Linus Pauling. Dr. Whitaker is the author of several books including the best-selling Shed 10 Years in 10 Weeks.
