The Dietary Health and Education Act of 1994 (DSHEA) represents the effort of thousands of Americans who wanted the freedom to choose natural health products that contribute to good health. The natural products industry, consumer groups and various Congressional members joined ordinary citizens in the extraordinary pursuit of this freedom, a hard-fought legislation designed to provide a reasonable path to market for dietary supplements, while safeguarding the public from potential dangers. "We worked hard to create a regulation that covered all the areas of concern," said Sen. Orrin Hatch (R-Utah), one of the co-sponsors of the legislation and a longtime advocate of the importance and safety of the greater supplement and nutrition industry.
DSHEA gave FDA many powers, including the ability to develop, implement and enforce health claim guidelines and good manufacturing practices (GMPs) for supplements. Slow in carrying out these mandates, FDA made little progress on the GMP front by the time the industry and Congress responded to growing criticism and suspicion of the safety of supplements by supporting and enacting, respectively, the Dietary Supplement and Nonprescription Drug Consumer Protection Act in 2006, requiring manufacturers and responsible parties to log serious adverse event reports (SAERS) and submit them to FDA. At present, these various regulations require manufacturers to provide scientific support for any health claims made; test incoming materials and perform various manufacturing and storage procedures by strict methods documented fully in paperwork subject to FDA inspection; and record any AERS, serious or not, and submit SAERS to FDA within a designated timeframe. On top of this, regulation on new dietary ingredients (NDIs) requires manufacturers to notify FDA 75 days before marketing any ingredient, which was not in regular commerce before Oct. 15, 1994 (unless on the list of specially grandfathered ingredients). By this, the ingredients not subject to the NDI rule are assumed well-known by FDA.
Given all these regulations, why is the supplement industry suffering from increasingly negative attention from the media, government, consumer groups, sports organizations and many other Americans?
The biggest problems drawing the negative attention are rooted in quality control (QC) issues, although misleading and disease claims certainly play a significant role. Among the criticism lobbed at the supplement industry are products either not containing what is on the label or containing compounds not on the label. The greatest harm in a product falling short of the labeled amount of a nutrient or active ingredient is that it doesn't work and leaves the customer dissatisfied. However, for products containing unlabeled substancesadulterantsthere is potential public health risk, which is the basis of the recent scrutiny of DSHEA. Economic adulteration also hurts the marketplace for legitimate products by offering artificially low prices (due to the cheap adulterants used) and bringing negative focus and stigma on the product categoryone bad apple spoils the bunch.
One of the challenges in combating economic adulteration is getting a handle on what kinds of adulteration exist in the market.
FDA defines economic adulteration as: The fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain. In recent years, the agency has concentrated its anti-adulteration efforts on sports nutrition, sexual dysfunction and weight-loss products that are marketed as supplements, but contain undeclared drug compounds found in pharmaceutical products of similar focus.
In these product categories, adulterators prey on consumers desperate to build more muscle mass, lose weight or solve a sexual dysfunction. For such criminals, consumer satisfaction is just a matter of pharmaceutical spiking.
For example, FDA looked at MetaboSlim, from Confidence Inc., a couple of years ago and found it contained sibutramine, a drug approved by FDA for use as an appetite suppressant. The company recalled the product in 2007. More recently, Young You Corp. recalled four products it was selling as weight-loss supplements, after FDA found they also contained sibutramine. In both cases, product was sold on the Internet or direct from the manufacturer.
FDA has warned consumers about such products, which it considered unapproved drugs, noting its laboratory tests have found sibutramine, fenproporex, fluoxetine, bumetanide, furosemide, phenytoin, rimonabant, cetilistat, and phenolphthalein in weight-loss products being as supplements or over-the-counter (OTC) products.
Society prepares the crime, the criminal commits it. - Henry Thomas Buckle, British historian
New weight-loss products hit the market constantly, making it hard to keep track of the good and the bad. This is one market where the "next big thing" is a clear driver for many who are desperate to shed unwanted pounds and have been unsuccessful with more traditional weight management protocols and products. Also ripening this market for adulteration is the single-bullet mentality pervasive in society, which seeks and demands immediate gratification and results. For the criminal mindset, the best way to ensure such quick and effective results is by spiking their products with undeclared pharmaceuticals known and marketed.
This is the same situation at play in the market for sexual-health products, especially erectile dysfunction (ED). In 2009, FDA found Opteron 1 Inc. (dba Nature & Health Co.) marketed several ED products as supplements, but they contained pharmaceuticals known to treat ED, including tadalafil, aminotadalafil and sidenafil. In a similar 2009 case, Halotecos ED product label stated it did not contain tadalafil, but FDA tests confirmed the drug was indeed present in the product, making it an undeclared, unapproved drug, not a dietary supplement.
In the sports-nutrition market, adulteration most often involves either illegal steroids or new steroid-like compounds that fit the definition of substances the Drug Enforcement Agency (DEA) would investigate as candidates for controlled substances under the recent steroid laws. FDA issued a public advisory in July 2009, warning it has found several products marketed as bodybuilding supplements with ingredients that are anabolic steroid alternatives and/or are steroid-like, but which contain synthetic, designer steroid compounds. They are often promoted as performance or recovery aids, according to FDA, which further reported it has received SAERS, including serious liver injury, stroke, kidney failure and pulmonary embolism.
Technological progress is like an axe in the hands of a pathological criminal." - Albert Einstein
Those who adulterate use technology as either a weapon or a cloak. For some, the Internet is a main thoroughfare for marketing and selling adulterated products to consumers. This is especially true of bodybuilding/sports, weight-loss and sexual dysfunction products. FDA and FTC have taken their surveillance of these products to the Internet, taking action where necessary, including warning letters and other enforcement.
In the case of steroids and sports products, technology is also used to keep ahead of testing and regulators. The Controlled Substance Act has been amended twice, giving DEA the authority to classify new, designer steroid ingredients as controlled substances. However, DEA has complained that by the time they go through the process of scheduling a new "designer steroid" as a controlled substance, a bunch of new such ingredients have already hit the market to replace the ones under the government microscope.
The Garden of Adulteration
If Eden was a botanical paradise tainted by an evil serpent, the herbal product industry is its modern-day doppelganger with many snakes slipping fake, subpar substances into products posing as various herbal supplements studied for health benefits. While such adulteration also occurs in foodthe use of melamine by a Chinese company to give the appearance of certain protein levels in infant formulas and pet foodsthis scam is especially prevalent in herbal supplements marketed for certain levels of specific actives.
The worst crime is faking it. - Kurt Cobain
Standardized extracts of medicinal herbs are seen as a consistently high-quality botanical supplement and, therefore, enjoy higher demand and command higher price points. Given the high expense of such products, scoundrels spike their products with cheaper, non-labeled compounds that artificially boost test results for such active ingredients. While there is likely a wide-range of herbs affected by this practice, a few segments have well-known problems with such adulteration.
Famous for helping to improve memory and microcirculation, Ginkgo biloba extract has long been standardized to 24 percent flavonol glycosides and 6 percent terpene lactones. This extract is based on an average 50:1 ratio, meaning from 100 kg of dried ginkgo leaves, only 2 kg of the extract are obtained, according to Jochen Muelhoff, Ph.D., Dr. Willmar Schwabe GmbH, the German company that set this standard more than 40 years ago. This adds up to an expensive ingredient.
As achieving the 6 percent terpenes is reportedly an easy feat (ginkgo leaves are terpene-heavy, but flavonoid-light), scam artists focus on the flavonoid content by adding extra flavonoids from non-ginkgo sources. This allows them to undercut the price in the market, but it also fools the customer, as the studies on memory benefits were conducted on the 24/6 extract, and the benefits may come from more than just the flavonoid content, despite its use as a marker.
Bilberry (Vaccinium myrtillus) is well-known for its anti-inflammatory and eye-health benefits, but customers unknowingly consuming an adulterated product will not enjoy the full, researched benefit of this powerful botanical. The extract standardized to 25-percent anthocyanins is the one used in the numerous studies on ocular health, microcirculation, vascular integrity, intestinal problems, and both kidney and liver damage. However, criminals are spiking their bilberry products with amaranth dye and other adulterants to fake the expected anthocyanin levels in testing.
With the price of true bilberry 25-percent extract ranging from $600 to $800/kilo, adulterators see much potential in slipping in pigment or mulberry or black rice husks to create fake 25-percent extracts that cost them as little as $50/kilo to make but net them around $400/kilo in the marketplace.
The standardized extract of saw palmetto should contain at 85 percent to 90 percent fatty acids and plant sterols, such as beta-sitosterol, per the supplements used in the many studies showing benefits to men suffering from enlarged prostate or benign prostatic hyperplasia (BPH). A short-harvest period and weather-affected crop only found in abundance in Florida sets this herb up to have some high prices in certain seasons. To combat this, rogue suppliers will boost their saw palmetto product with other oils, such as palm or olive oils, rich in the fatty acids found in saw palmetto.
In the case of pomegranate, the exploding popularity of the vague segment called superfruits, coupled with the expense required to make its extract standardized to ellagic acid (40 percent or higher), makes this herbal product a prime target for adulteration. According to Lora Xiong, MS, Xianguo He, Ph.D., pomegranate fruit typically contains only 0.3 percent to 0.5 percent ellagic acid, so to achieve the 40 percent exclusively from pomegranate would require tons of fruit and a great expense. The price on the market would be about $400/kilo, yet the market is riddled with 40-percent extracts selling for as little as $35 to $75/kilo by fraudsters that boost their extracts with pure ellagic acid, which is reportedly cheap to obtain. In fact, a study of 27 commercial pomegranate supplements found only five had a profile typical of pomegranate tannins, while 17 products had ellagic acid as the predominant chemical. The researched anti-cancer and antioxidant benefits of pomegranate are likely due to the synergistic effects of the multiple constituents found in the whole pomegranate, not just the ellagic acid, so these adulterated, fake standardized extracts are misleading and detrimental to the progress being made in the legitimate market.
It is easy to see the main scofflaws responsible for these crimes of economic adulteration are the people or companies that perform the adulteration and create the harmful unapproved drugs or artificially boosted products. However, there is more blame to go around, and this messy situation of economic adulteration and the problems it is causing for the supplement industry and DSHEA can be partially pinned on many players.
He has committed the crime who profits by it. One crime has to be concealed by another. - Seneca, Roman philosopher
Some buyers make purchases based purely on price and promise. Unfortunately, a certificate of analysis (C of A) is not sufficient documentation of a raw material's quality, and buyers must perform additional due diligence to learn more about the materials and the supplier. Whether some manufacturers willingly turn a blind eye to numerous red flags adorning suppliers that pedal adulterated ingredients, or such manufacturers are just negligent and/or lack the resources to undertake proper due diligence, the crime of adulteration is still propelled by a lack of proper quality control by secondary parties.
If you share your friend's crime, you make it your own. - Latin Proverb
Buyers and manufacturers who accept adulterated product and fail to qualify the supplier or properly test the incoming product are just as criminal and hurtful to the consumer and the industry. Under GMPs, any company manufacturing and marketing a product as a supplement is required to perform adequate identity and quality testing.
AHPA recommended FDA revisit a July 2007 petition submitted by American Herbal Products Association (AHPA) that suggests FDA require under dietary supplement GMPs that companies receiving product in manufactured form conduct examinations or tests to verify that identity and other specifications were met, as is required of dietary supplement manufacturers receiving dietary ingredients. This requirement for dietary ingredients provides significant protection against any manufacturer inadvertently, including a deliberately adulterated dietary ingredient in a manufactured dietary supplement.
Still, Andrew Shao, vice president of scientific and regulatory affairs at CRN, explained to FDA the global supply chain has made the sourcing and tracing of raw materials exceedingly complex. He warned GMPs, even when thoroughly implemented are not themselves adequate to defend against economically motivated adulteration.
The GMPs for dietary supplements do not include any requirements for ingredient suppliers, which will remain under food GMPS, but they do require manufacturers to qualify their suppliers. However, in the void where specific supplier qualification guidelines from FDA should be, the opportunity for economic adulteration is great.
The supplement industry trade groupsCRN, Natural Products Association (NPA) and AHPAhave touted their collaborative SIDI (Standardized Information on Dietary Ingredients) protocol, which helps improve communication and data sharing between manufacturers and suppliers. Any supplier not using this or a similar method of qualifying suppliers may very well be contributing to the perpetuation of economic adulteration and increased scrutiny of the supplement industry and DSHEA.
In the end, the only way to be sure the incoming material is high quality, and is what it is supposed to be, is to test it after the shipment is received. For some materials, this might mean complex, expensive testing, but for other ingredients, the tests can be basic and cheap, such as organoleptic testing.
Commit a crime, and the earth is made of glass. - Ralph Waldo Emerson
One of the greatest tools food and supplement industries have is testing. It isnt easy to stay ahead of the cheats, but only through the continued development and use of effective testing methods and protocols will the market be made of glass and the criminals unable to walk away from their crimes unnoticed and unscathed.
For most of the ingredients affected by adulteration, there are test methods developed to help weed out the fake product. For some ingredients, such as saw palmetto, the best test method to ensure pure herbal extract is not widely known and can be expensive to conduct in-house. For other ingredients, such as bilberry, the test methods are relatively easy to implement, according to Christian Artaria, Indena, who noted the problem is one more based in ethics, regulation and enforcement.
Crime and bad lives are the measure of a State's failure, all crime in the end is the crime of the community. - H.G. Wells
The continuing lack of enforcement of the tenets of DSHEA by FDA, not to mention the slow handling of the controlled substances act by DEA, is contributing to increased economic adulteration and the negative attention on the supplement industry and DSHEA.
I see no reason to anticipate that any serious effort will be made to enforce DSHEA in a manner that suggests the law works, said Marc Ullman, partner at Ullman, Shapiro & Ullman. You will see enforcement activity when it provides a platform to say this problem was created by DHSEA and might not have existed if we didnt have DSHEA, but I dont think you will see enforcement undertaken in a way that remotely suggest DSHEA works. This is evident through [FDAs] actions and inactions, especially under current regime.
For its part, DEA has complained that it takes too long to schedule new controlled substancesin the five years since their powers were expanded, the agency managed to only schedule three new steroidsand by the time they schedule a steroid, many more, new steroids have infiltrated the market. The Senate has indicated changes might be considered to the process DEA must follow, especially in cases where a compound is a known steroid. Removing the red tape involved in this process would go a long way to keeping up with those who continuously design new steroid-like compounds for use in products marketed as supplements.
Every society gets the kind of criminal it deserves. What is also true is that every community gets the kind of law enforcement it insists on. - John F. Kennedy
A grassroots effort helped drive the passage of DSHEA. Where is this outcry and effort to get better enforcement of existing regulations, better deterrents to the criminality of EA? Where is the support for those in the industry who are defending DSHEA?
DSHEA is under siege; it is at risk, Ullman warned. The supplement industry has done an abysmal job getting its message out, and that goes back to lack of resourcesthe industry representatives in Washington, the trade associations, are working very hard with incredibly limited resources.
The lack of outcry for more funding and pressure on FDA from the public and their Congressional members only perpetuates this condition.
In a recent Senate hearing on steroids in bodybuilding products, Arlen Specter (D-PA) suggested Congress may look at premarket approval for bodybuilding supplements and all dietary supplements. Other Congressional members, such as Henry Waxman (D-CA), have suggested DSHEA is not adequate for regulating supplements and protecting Americans.
Locks keep out only the honest. - Jewish Proverb
Many in the supplement industry argue premarket approval would not solve the problem, but punish the responsible companies. If criminals dont obey the laws that already exist, why would they obey new laws? The key is enforcement and deterrents.
In the case of designer steroids, Richard Kingham, Covington & Burling LLC, suggested it is important FDA exercises it authority and follow through on enforcement threatsseizures, injunctions and criminal prosecutionin cases of continued flouting of the law.
Ullman echoed this sentiment, saying, Putting something cheap into a product to increase your profit, putting a drug ingredient into something and labeling it a dietary supplement, or including a NDI in a product without giving FDA a 75-day notification are all cases of economic adulteration and are all illegalthis was the case before DSHEA and today. He noted these cases are all in FDAs discretion as potential criminal offenses, reminding the agency has the authority to push the Justice Department to bring criminal cases, but never uses this tool. GMPs will, in general, improve the situation but if there is no enforcement, if FDA doesnt shut down companies that ignore laws, what would make anyone think a company that adulterates would care following about GMPs?
FDA contends it is motivated to curtail economic adulteration due to the ongoing public safety concerns, and held a public meeting to get input from stakeholders on the situation. However, consumer confidence is waning in certain areas of food, drug and supplements, as well as the regulators of these products. Adulteration cases have left the public unsure and not trusting of what is in the products they ingest. Whether its marketing unapproved drugs as supplements or faking a specific ingredient level for increased profit, economic adulteration is a crime committed by criminals, but DSHEA is the one on trial. In both cases there is a coordinated effort to suggest that this is DSHEAs fault, Ulmman said. And the people advancing that argument are either ignorant or are lying. No matter who is to blame, the industry is squarely on the media and regulatory radar, and the time for those whose livelihood depends on DSHEA to act is now. This means earnestly working together, utilizing industry resources and information, improving QC, following GMPs, supporting the trade associations, pressuring Congress and banishing the criminal adulterators.
The Quality Control section is sponsored by Ethical Naturals; however, the company does not review or approve editorial content.