Bad Sex

Good sex is invaluable, or at least expensive. The price of pharmaceutical sex drugs such as Viagra® and Cialis® have skyrocketed in the past few years. While sales for these top erectile dysfunction (ED) brands have finally tapered off after years of strong growth, the overall revenues in this category are still about $2.9 billion (GlobalData). Given the cost of ED drugs and the increased demand created by the effectiveness and growing acceptance of the ED problem, it is no surprise consumers have turned to natural alternatives to ED drugs.

ED dietary supplements are not as fast-acting as ED drugs. This plus the market opportunity for alternative ED products have ripened the ED supplement market for economic adulteration. If an unscrupulous supplier or manufacturer gets consistent positive feedback for its immediate efficacy, the customers of that company are sure to continue to buy that material or product. In the ED market, immediate and consistent win quick fans and quick bucks.

Sexual function supplements, including ED and libido products, were among three supplement categoriesbodybuilding and weight loss are the other twocalled out by FDA as having alarming adulteration problems. And the alarm sounded in the form of a stiff warning letter issued in December 2010 from FDA chief Margaret Hamburg:

How big is the problem? FDA said it had, to date, alerted consumers to hundreds of cases of supplement adulteration and has worked with industry to recall more than 70 sexual enhancement products tainted with drug ingredients such as sildenafil (Viagra®), tadalafil (Cialis®) and vardenafil (Levitra®).  The list of such products that have generated warning letters, recalls or even seizure include: Rock Hard Extreme, Stiff Nights, Vitalex, Super Shanghai, Night Rider Maximum Sexual Enhancer for Men, STUD capsules, ReviveXXX, Stamina-Rx, Libipower Plus, Hard Drive, Monster Excyte and many other  products with suggestive and colorful brand names.

We think there are more tainted products in the market than clean ones, said Rekha Patel, business manager for Exotic Naturals, which makes HeezOn sexual health supplement. FDA is increasing vigilance and is also increasing consumer awareness; this is good for ethical marketing.

For once, the call to arms has used the word criminal in its potential enforcement description. In announcing the letter, Hamburg said companies operating in this illegal manner face not just warning letters but enforcement actions such as product seizures, injunctions and legal action. Individuals involved in the illegal operation can also face criminal prosecution, she added. Her letter punctuated this point, citing United States v. Park, 421 U.S. 658 (1975), as evidence of the ability to criminally prosecute responsible individuals, whether such person did not participate in, encourage or have personal knowledge of the violation. It also stated felony charges are possible.

The letter also spelled out the legal statutes at play:

In a strong statement about adulteration motivations, FDA noted meaningful levels of active drug ingredients, such as those in products marketed as sex supplements, are not accidental, but somewhere in the supply chain, the active ingredient is incorporated into the ingredient or the finished product. The agency suggested a strong program of qualifying suppliers, testing incoming ingredients and verifying the contents of finished products can help minimize those risks. These suggestions are all part of the recently implemented GMPs (good manufacturing practices) for dietary supplements.

R.V. Venkatesh, managing director of the Gencor Pacific Group, said his company ensures tainted raw materials never enter its TESTOFEN product, which is manufactured by the group's sister company, by taking a pharmaceutical approach to nutraceutical manufacturing and marketing.  The facility is ISO-approved and has GMP certification, he noted. We have strict quality control procedures in place from procurement of the fenugreek seeds used in the manufacture to every step of the manufacturing process. Our manufacturing procedures, SOP's [standard operating procedures] and documentation procedures are of rigorous pharmaceutical standards.

Exotic Naturals reported its ingredients and its final product are both manufactured in compliance with GMPs. Patel further suggested scientific studies are needed to clearly demonstrate product safety, and third-party or consumer watchdog groups can also test product to determine safety and contents.

Longtime researcher Jay Udani, M.D., CEO of Medicus Research is acutely aware of possible adulteration in sexual function supplements. His company recently performed a pilot study on a Eurycoma longifolia freeze dried water extract (as Tenaga, from Biotropics) and included a test for adulteration in the protocol. Results of the randomized, placebo-controlled trial in men with ED showed the supplement was free of adulterants and was linked to improved sexual performance and satisfaction. While not common, this is the gold standard for products with the potential for adulteration, Udani said. This study was initiated over a year before the current regulatory announcements concerning this problem, and Medicus Research required this testing as part of the startup process of the study.

Udani confirmed due to growing distrust of products in the sex supplement marketplace, the bar has been raised for scientific proof of not just efficacy, but also safety and purity in sex supplements. He said this level of accountability is required to follow current regulations, including GMPs. Collaboration between industry groups, regulatory agencies, consumer watchdog groups, and the companies themselves will be required to fully address this problem.

Venkatesh also trumpeted science as a cornerstone of quality and efficacy in sex supplements, noting his companys products have undergone double blind, placebo-controlled, randomized research in Australia to validate and prove efficacy in increasing adult male libido. He reported one study has been accepted for publication in  Phytotherapy Research journal. Our animal study showing the aphrodisiac, anabolic and androgenic properties of TESTOFEN was also published last year in the same journal, he added, noting these publications are a testament to the quality of our science and the efficacy of the ingredient. Science of this quality assures our clients that in TESTOFEN they have the guarantee of a top quality genuine ingredient backed by science and clinical studies.

Sending tips to FDA can finger the potential adulterated products, but science and testing is what ultimately fingerprints the criminal activity and leads to enforcement. In fact, for marketers who buy ingredients and contract their manufacturing, the only way to truly know a finished product is adulterant-free is through supplier qualification, which is dominated by testing.

When Natrient Inc. received a warning letter from FDA in summer 2006, the company was extremely concerned. FDA informed management the product, Nasutra, contained acetildenafil, which FDA explained was a synthetic analogue of sildenafil.  Natrient CEO Ira Josephs said his company received pre-blended finished product from one supplier/manufacturer, which was sent to a contract manufacturer for encapsulation only. So, the problematic ingredient was present in the formula from the manufacturer, he noted. Natrient had previously submitted a sample from every batch for independent analytical testing, but because there was no standard for identifying acetildenafil at that time, the analytical tests came back negative.

We were introduced to the supplier by a mutual contact, he said, noting the supplier was a team of three individuals: a Ph.D. with a long resumé of product development projects for well-known companies, an experienced naturopath with an extensive background in Traditional Chinese Medicine (TCM) and a business partner.  They supplied the complete formula in pre-blended powder form, ready for encapsulation.

 After the warning letter and recall, Natrient initiated legal action, but the supplier's entity was foreign, so the action didn't get far. The naturopath claimed the acetildenafil found in the formula was derived naturally and qualified as a dietary supplement, Josephs noted. He claimed there's a professor in the U.K. who demonstrated this fact, but it didn't matter to us. The bottom line was that the FDA said it was an unapproved drug.  End of story.

Josephs said Natrient did not have any direct contact with FDA, but instead chose to hire an experienced FDA attorney, who was recommended by a trusted industry veteran and who guided them through the process.  Josephs noted FDA was neither helpful nor aggressive.  They were serious, and we responded to every request accordingly.

A testament to lessons learned and the power of education and enforcement, Natrient has re-launched the brand using a new formula from a new and qualified supplier. The company now sources and purchases every ingredient that goes into the Nasutra formula, and it is fully compliant with all dietary supplement regulations, according to Josephs, who said his company was not required to provide the FDA with any information in order to re-launch the brand.

The story of companies such as Natrient that are unprepared for quality operation in a GMP supplement world and that may be, to some degree, unfortunate victims of an unscrupulous supplier underscores the importance of supplier qualification.  The supplement industry has tried effortlessly to promote not just the idea and criticality of supplier qualification, but also a set of tools to help companies with this process. The leading supplement trade groupsthe Council for Responsible Nutrition (CRN), American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA) and Natural Products Association (NPA)developed the SIDI (Standardized Information on Dietary Ingredients) protocol to help supplement companies perform supplier qualification to support GMP compliance.

The SIDI protocol was designed to integrate information on raw materials sourcing by way of a voluntary, standardized system, thereby eliminating the need for questionnaires. The standardized format was also intended to improve the audit process, as well as educate smaller, less-experienced firms on regulations, requirements and best practices.

A SIDI working group, comprised of the founding trade associations plus the United Natural Products Association (UNPA) and a number of leading supplement companies, maintains the SIDI protocol. At the recent SupplySide West trade show in Las Vegas, November 2010, members of the working group updated a packed room of industry attendees on SIDI, including the importance of a risk-based assessment model for better categorization of suppliers, in addition to the need for industry-wise adoption to set common standards and practices. Information on SIDI can be found at CRNUSA.info/SIDI/.

Chris Kilham, the Medicine Hunter and scientific advisory board member for EuroPharma, which makes its Organic Andes Maca product for improvement of healthy libido and energy, among other benefits, takes supplier qualification to a higher level by personally witnessing every aspect of the handling of this maca, from seed to finished extract. I know the maca product is not adulterated, because I personally visit the fields where the maca is grown, I know the growers personally, I observe every aspect of maca processing, and I also work directly with Naturex, which extracts the maca, he explained. I know the bacterial tests, the heavy metal tests, the pesticide tests, the other contaminant tests. This is very rare. Most companies get their ingredients by picking up the phone and calling some guy somewhere. He advised other supplement companies that really want to know a product to actually participate in every phase of that product; otherwise there is no way to claim knowledge of your product.  Forget relying on certificates of analysis (CoA), he said. They are like promisesthey are cheap to make, and people never run out of them.

For its part, Natrient changed the way it approached sourcing and found new suppliers.  Several months prior to receiving the warning letter, we began working with a leading nutraceutical R&D firm to expand our product line, Josephs said. That relationship was the beginning of our evolution from a one trick pony to a real natural products company.  We developed relationships with individuals who opened our eyes to new ingredients and new possibilities. He noted even though the company now knows exactly what it is putting into the product, it still submit samples to a leading analytical lab to demonstrate the product is adulterant free.

Still, for every story of a naïve sex supplement company righting its QC ship relative to adulterated ingredients and sourcing and manufacturing protocols and regulations, there are undoubtedly many companies that are not bent on operating within the rules. This situation is the most concerning, as the consequences for the entire sex supplement market, if not the entire dietary supplement industry, are potentially dire.

The actions of a few fly-by-night operators have given a bad name to the whole industry, Venkatesh lamented. It is time the authorities cracked down heavily on marketers of such products. Stringent measures are required.

FDAs former deputy commissioner, Joshua Sharfstein, identified several red flags, such as: any labeling about being an alternative or similar to FDA-approved drugs; marketing primarily in a foreign language; products marketed via mass e-mails; and sexual enhancement products promising rapid or long-lasting effects.

Patel said his company and product operate outside this red light district of promises of fast, strong and hard sexual benefits. HeezOn is not positioned and is not effective as a male enhancement, performance or leisure product for healthy males desiring instantaneous and super effects, he affirmed. Hence, we are not competing with hundreds of instant performance boosters. He explained his product is intended to support consumers who are looking for health and not leisure, and who are actually suffering from loss of libido, ED and premature ejaculation due to factors such as age, stress, diabetes and hypertension.

Maca has far broader uses than delivering a stiff erection, Kilham stated. In fact, it isn't an erectile product. He said maca is more of an adaptogen that imparts energy, stamina, endurance and overall well being, while enhancing libido. Maca is not likely to be tainted by the adulteration scandals that have plagued erectile herb formulas, he claimed.

Still, Kilham confirmed the challenge of launching a new sexual health product is significant, because the market is flooded with products, many companies make wildly exaggerated claims, and many consumers dismiss the efficacy of such products out-of-hand. Adulteration of sex herbals with pharmaceutical drugs is yet one more layer of nonsense we don't need, he bemoaned. The climate is rough.

Venkatesh added, It is indeed tough to get customers to believe that a libido-enhancing supplement is legitimate and of high quality. But in the end, a combination of persistence, education and science always wins, as the success of TESTOFEN has shown.

Kilham assured convincing customers that the product is safe and not adulterated falls largely upon the reputation of the finished product company. EuroPharma has an excellent reputation, as does the companys founder, Terry Lemerond, he said. He's not about to tolerate adulteration of one of his products to make a fast buck; it would destroy his business, and there is no benefit to that.

In the case of a company that learned a hard lesson and suffered damage to its reputation, Josephs said Natrient deserves a second chance in the marketplace because people and companies sometimes make mistakes. In our case, it was inadvertent, he reminded, but it happened and we had to deal with the consequences, including damage to our brand, our reputations and severe financial losses. He said his company handled the situation with integrity and used the experience as an opportunity to grow as individuals and as a company, and would never make the same mistake again.  

When it comes to his customers, Josephs reasoned the combination of the old bad press and the companys commitment to making things right will serve it well in the long-run and establish Nasutra as a reliable brand.  We could have easily come up with a new name, but we love the brand and consumers love it too. Regarding the authorities, he noted this wasn't a case of an intentional or repeat offense like the industry has seen with other adulterated product manufacturers or unscrupulous advertisers marketing products with false claims.  We are committed to being fully compliant and don't plan on giving the FDA any reason to ever contact us again, he promised. My primary concern is getting a second chance from supplement retailers. When a retailer recommends a product to their customers and it turns out to be adulterated, it reflects poorly on them.  It's going to take some effort on our part to win back their trust.

Overall, makers and marketers of high quality, legal sexual health supplements still see potential in this market category, despite the difficulties the adulteration problem has created. Kilham reminded in every category of consumer products, there are hustlers and lousy products, and sexual health supplements are no different.  If a company will put together a good formula (like Andes Organic Maca), will stick to existing science without exaggeration and will build business by satisfying customers honestly, there will still be room for sex-enhancing herbals, he assured. The category is tainted, for sure, but people are not going to stop having sex. They are going to want to be sexually energized, and they will continue to try products. This is a perennial category.