Tainted Nutraceuticals

The global nutraceutical market was estimated to be $140.1 billion US dollars in 2010. Concerns have arisen over the increasing cases of adulterated products in the market which threaten the health of the consumer and the continual growth for the nutraceutical industry.

US rulings such as the 1994 Dietary Supplement Health and Education Act (DSHEA), the 2007 Good Manufacturing Practice of Dietary Rule and comparable rules from other countries have set guidelines to ensure product safety and manufacturing compliance.   outgoing raw materials and finished products The U.S. House of Representatives has passed legislation clamping down on designer steroids and pro-hormones and giving more powers to the DEA.

We’ve been following progress of the Designer Anabolic Steroids Control Act 2014, as it edges closer to becoming law and banning many popular over the counter designer steroids and prohormones.

The U.S. House of Representatives passed a voice vote enabling the Drug Enforcement Agency (DEA) to clamp down on many legal anabolic steroids, sold as designer steroids, legal steroids and prohormones.

Additionally, the DEA would have grounds to seize products similar to anabolic steroids, but with slight chemical changes far quicker than they can at present, and fine supplement manufacturers a massive $500,000 per violation for mislabelling anabolic steroids as dietary supplements.

The Designer Anabolic Steroid Control Act (DASCA) would also allow the DEA to temporary schedule designer steroids on their controlled substances list, preventing their sale, distribution, manufacturer and importation almost immediately. Tougher civil and criminal penalties are also going to be evident when the DASCA is fully passed and signed off by President Obama.

In total 27 compounds are to be added to the prohibited and controlled substances list, some of which are favorites by bodybuilders and athletes. Products such as, Halo Extreme, Mdrol, Epistane, 1-AD, Havoc, Trenavar, Dianabulk and many others. Much like any drug that’s made illegal, you’ll still be able to obtain it somewhere, but prices will be pushed up, quality may also be compromised.

Rep. Frank Pallone (D-New Jersey), who introduced the bill to the house along with Rep. Joe Pitts (R-Pennsylvania), went on to warn of the dangers of anabolic steroids labelled as dietary supplements.

“Designer anabolic steroids can cause serious harm to consumers, as well as young athletes, who may unknowingly be using these products.”

It’s now a question of ‘when’ and not ‘if’ the DASCA will be passed, with more and more lawmakers and senators behind it.

The Council for Responsible Nutrition (CRN), who represents the dietary supplement industry, has also thrown itself behind making the DASCA law and banning dangerous over the counter supplements.

A group of UK researchers analysed 24 different pro-hormone and designer steroids.

What they find is a significant amount of mislabeled and under-dosed products. In the end, the trusted brand of that time (CEL) reigns supreme in terms of quality designer steroid clones.

There is no doubt that government agencies are aware of designer steroids that are not compliant to that country’s specific dietary supplement guidelines. Whether it be the United States, Australia, or the United Kingdom all 1st world countries have some sort of protective law in place that separates anabolic steroids, from dietary supplements.

Earlier this month a paper was published by United Kingdom researchers working with various organizations such as the London Drug Control Centre, Liverpool Centre for Public Health, and the European Monitoring Centre for Drugs and Drug Addiction. The paper was both a quantitative, and qualitative test of 24 “supplements” believed to contain some form of anabolic or designer steroid based on their review of online bodybuilding sites, and local gym members familiar with the products.

The paper unfortunately did not specify when exactly these products were purchased (many of them are now discontinued), but they were purchased from three online shops (17 of 24), one shop in Merseyside (4), and one in Cheshire (3). The author of Total Flex Blog, based in the UK, confirmed these were likely purchased years ago, as he also mentioned most are discontinued and have not been available in the UK for some time. This paper is particularly rare because it is uncommon for an in depth quantitative analysis. Below is a list of all the compounds tested, as well as they labeled dose, and recommended serving size.

What does it all mean?

Clearly these designer steroid and prohormone brands had some quality and quantity related issues. Keep in mind many of these brands were early entrants in the designer steroid market, so I suspect some of these facets of production and quality have since improved in the prohormone and designer steroid market. Also, as many of these brands and products are now known to be discontinued it’s unclear when they were purchased. It’s possible they were purchased as long as 3-5 years ago. This would explain why all the epistane/havoc products resulted in DMT.

In this study Competitive Edge Labs accurately labeled 5 out of 5 of their products (although one was underdosed per capsule). CEL was largely considered the leader in designer steroid clones just a few short years ago. This further illustrates the benefit of going with the “trusted” brands of our time.

Anabolic steroids detected in bodybuilding dietary supplements - a significant risk to public health. Abbate et all 2014

Twenty-four products suspected of containing anabolic steroids and sold in fitness equipment shops in the United Kingdom (UK) were analyzed for their qualitative and semi-quantitative content. Of the 24 products tested, 23 contained steroids including known anabolic agents; 16 of these contained steroids that were different to those indicated on the packaging and one product contained no steroid at all. Overall, 13 different steroids were identified; 12 of these are controlled in the UK under the Misuse of Drugs Act 1971. Several of the products contained steroids that may be considered to have considerable pharmacological activity, based on their chemical structures and the amounts present. This could unwittingly expose users to a significant risk to their health, which is of particular concern for naïve users.

Protodrol

Actual contents were believed to be Dihydro DMT or “reduced DMT”.  Otherwise known as “Protodrol”

What's in Cynostane of AI?

The researchers could not tell with only the standard analyses. But on basis of their further analysis the researchers believe that it contains the [3,2-d]-isoxazole-isomer of androisoxazol. ( Androisoxazol ([3,2-c]isoxazole) Actual contents were Androisoxazol ([3,2-c]isoxazole) this result is questionable.

What's in Epivol Black?

According to the label Epivol Black contains the relatively safe but very effective oral anabolic steroid methylepothiostanol (the active ingredient in Epistane), but routine tests found small amounts of androstenedione and of methasterone (the active substance in Superdrol ). Upon further analysis, the researchers found the steroid that you see above: 6-bromo-androstenedione (an aromatase inhibitor). Approximately 1 mg was androstenedione, and 2.4 mg’s of superdrol, while the 6-bromo was not quantified.

Dr. Pieter A. Cohen of the Harvard Medical School and colleagues investigated the possibility that such prohibited products are still available to consumers, even after the FDA’s recall is in effect. They examined the availability of supplements that were recalled due to adulteration between January 2009 and December 2012; the products had to be available for purchase in July or August 2013 from the websites of manufacturers or retailers; the supplements were the same as those listed in the FDA’s recall.

During the period scrutinized, the FDA recalled 274 dietary supplements; of these the researchers found 27 that met all their criteria. Two-thirds of these supplements were still adulterated eight to 52 months after the FDA had recalled them. In particular, 85 percent of those for sports enhancement, 67 percent of those for weight loss and 20 percent of those for sexual enhancement were still adulterated with banned ingredients. Further, most of these supplements contained the same ingredient that had led to the recall.

The Harvard researcher Pieter Cohen wants you to know that your supplements can kill you

In the past, people looking to get high on designer drugs had to seek them out, knowingly risking their health on products like "bath salts."

Now, new research suggests that many consumers may be unknowingly ingesting similar untested designer stimulants — because over-the-counter nutrition supplements can be laced with them.

That's the conclusion of a new study published in the journal Drug Testing and Analysis. "This is the third time in the last year that we have seen a brand-new class of drugs appear in mainstream supplements," said lead author Pieter Cohen, an internist and assistant professor at Harvard Medical School, who conducted the research with colleagues in Michigan and the Netherlands.

Cohen and his co-investigators examined over-the-counter supplements for the presence of a new, designer stimulant called DMBA. Designer drugs are just synthetic variations on the chemical structure of existing drugs, made to have similar effects but avoid being classified as illegal. In this case, DMBA is a man-made version of the chemical DMAA, also known as as 1,3-dimethylamylamine, methylhexanamine or geranium extract.

"It took people getting sickened by it — having bleeds in their heads, dropping dead... that finally moved the FDA to get DMAA off the market."

The researchers found DMBA — the new designer stimulant — in a dozen supplements. The health effects of DMBA are unknown because it has only ever been studied in a small number of cats and dogs, but never humans. And DMAA — the parent compound from which DMBA is derived — was banned in the US, UK and several other countries because it is linked to strokes, heart failure and sudden death.

"In 2006, DMAA was introduced on the market, but it should not have been in supplements," said Cohen. DMAA was found in dozens of sports and diet pills, selling to the tune of $100 million in 2010 alone.

"It took people getting sickened by it — having bleeds in their heads, dropping dead running marathons, that pathologists realized were due to DMAA — that finally moved the Food and Drug Administration to get DMAA off the market. That was seven years after it was introduced."

But while it's now illegal to put DMAA in supplements because it poses such a health risk, the new research shows manufacturers are using a sister chemical instead. With their new discovery, Cohen said, "There is no need to wait seven years. Here we are finding the next version of DMAA called DMBA."

Nutrition supplements are very loosely regulated

Cohen is a critic of the way the Food and Drug Administration regulates supplements, and said consumers need to be on alert since the labels on their pill bottles might not tell them the full truth about what they are putting in their bodies.

Supplement manufacturers are not required to prove that their products actually do what they are marketed for in humans. So these pills can be promoted for weight loss or any number of health benefits, with no real evidence backing the claims. As Cohen showed, they may also contain chemicals and designer stimulants that have never been tested before.

There's no organized approach to collecting information about the adverse effects related to supplements, he explained. "So the combination of no human trials before these products reach store shelves combined with fact we have no systematic way of detecting harm, it's like throwing a match into a forest during a drought."

There's growing evidence that supplements can be harmful

The new study is part of a growing body of evidence on the dangerous health effects related to supplement use. Liver damage and failure from these pills has been a well-documented problem. In one example, Cohen writes about in a recent Harvard Public Health Review article, the Centers for Disease Control and Prevention found that the weight-loss supplement OxyElite Pro caused nearly 100 people in 16 states to develop hepatitis, leading to liver replacements, hospitalization, and even death.

The Federal Trade Commission has been waging war on weight-loss supplements, too, recently suing the makers of popular products such as green-coffee beans for misleading and harmful marketing practices.

Dr. Mehmet Oz, host of the popular Dr. Oz Show, has featured some of these weight-loss supplements on-air, and was dragged before a senate sub-committee last summer to explain why. As one senator put it: "The scientific community is almost monolithic against you in terms of the efficacy of those three products that you called miracles."

Consumers need to proceed with caution

Until there's a more robust regulatory process, Cohen said it has to be buyer beware. "This category of supplements is sold as if they're going to help you: supplements for weight loss, to improve workouts in the gym. They are often labelled as having tons of diff natural ingredients combined. But actually they might rely on one chemical to have this effect." And that chemical might be dangerous.

"No consumer product should kill you. With supplements, we accept it's okay to take these pills, even if they might lead to a heart attack or stroke. To me it's mind boggling that we accept this."

Your dietary supplement might contain banned drugs

Searching for a safe, natural product to help you lose weight, boost your libido, or pump up your pecs? Don’t be fooled by the seductive marketing claims for Botanical Slimming 100% Natural Softgel, Slim Xtreme Herbal Slimming Capsule, or Magic Power Coffee. Those supplements aren’t healthy, let alone magical. In fact, all three have been recalled by the Food and Drug Administration for containing banned drugs.

That would be a great success story except for this hitch: More than six months after they were supposedly yanked from the market, researchers found that many supplements recalled by the FDA are still being sold and still contain banned drugs. That revelation appears October 2014issue the Journal of the American Medical Association.

“The bottom line is that the FDA is simply not getting the job done,” said the study's author, Pieter Cohen, M.D., an assistant professor of medicine at Harvard Medical School and an authority on dietary supplements. “Our laws are lax when it comes to regulating supplements. But it is at least clear that you cannot sell pharmaceutical drugs as if they are supplements.”

Cohen and his team tested 27 easily obtained supplements out of 274 that had been recalled between 2009 and 2012 for containing banned drugs. His study, financed in part by a grant from Consumers Union, the policy and advocacy arm of Consumer Reports, found that two-thirds of the supplements were not only still easy to acquire, but also contained either the exact chemical the FDA had detected or another banned substance with a similar effect.

For example, they found that Slim Xtreme Herbal Slimming Capsule, which comes in a tantalizing package boasting that it will make you “Lose up to 20 Pounds in JUST 4 WEEKS!” contained sibutramine, a banned obesity drug similar to amphetamine. The drug may lead to some modest weight loss, Cohen said, but, “We know that it causes more harm than good when prescribed by doctors, so we can only imagine how much more harmful it can be when the doses vary.” Sibutramine, in fact, was withdrawn from prescription drugs in 2010 because it often caused side effects such as heart attack, stroke, dizziness, seizures, and depression.

Another supplement, Magic Power Coffee, pictured at top, is touted as a sexual enhancement drug that is “proven" to "increase libido” and “guarantee maximum potency.” It was taken off the market in 2010 when it was found to contain hydroxythiohomosildenafil. Yet Cohen’s team found that a recently purchased sample was spiked with a similar drug, sildenafil—the same drug found in Viagra.

Another harmful supplement, On Cycle II Hardcore, was removed from the market in 2009 when the FDA discovered that it was laced with a “steroid or steroid-like compound.” Frighteningly, Cohen’s team found that a recently purchased sample contained two anabolic steroids—drugs that may cause hepatitis, a severe inflammation of the liver that requires hospitalization. Steroids can also induce psychiatric changes, acne, and hair growth in men and women. Hardcore, indeed.

Cohen said that the FDA has spent millions tracking down tainted supplements and issuing warnings to their manufacturers. “The problem is that they don’t check that the products have been taken off the market,” he said. “There needs to be significant financial and legal consequences for repeatedly introducing banned substances in supplements.”

Without proper enforcement, Cohen said: “They are basically permitting manufacturers to continue selling these products that they themselves have identified as a high-priority risk to the public. There is no leadership. They send out alerts, but are they getting the products off the market? No.”

Watch out for these supplements

All of the supplements listed below were found to contain banned or potentially dangerous drugs (shown parenthetically).

Weight-loss supplements

Botanical Slimming 100% Natural Softgel (sibutramine)

Everslim (fluoxetine, sibutramine)

Mince Belle (fluoxetine, N-didesmethyl sibutramine—an analog of sibutramine)

Slim Forte Slimming Capsule (sibutramine, phenolphthalein)

Slim Xtreme Herbal Slimming Capsule (benzyl sibutramine, an analog of sibutramine)

Zi Xiu Tang Bee Pollen Capsule (sibutramine, phenolphthalein)

Bodybuilding supplements

2a, 17a Methastadrol (anabolic steroid)

E-Pol: Inslinsified (two anabolic steroids)

Finaflex 550-XD (two anabolic steroids)

Forged Extreme Mass (anabolic steroid)

Novedex XT (aromatase inhibitor and an anabolic steroid)

On Cycle II Hardcore (two anabolic steroids)

P-Plex (anabolic steroid impurities)

M-Drol (anabolic steroid)

Massdrol (anabolic steroid)

Sexual enhancement supplement

Magic Power Coffee (sildenafil)

To put all this in perspective, I don’t think all these slimming aids and roids are that bad, but I think everybody should make his or her own choice and be fine with all involved side effects. And that is only possible if you know what you are using.

 In the graphic prescription drugs are not listed, but you can imagine how many death they cause….