By Brandon Roberts
Herbal supplements promising to "enhance performance" or "improve sex drive" are big business to adult retailers-now even most local mini-marts stock a $3 pack of pills at the counter claiming to "increase stamina" with the help of an ancient, sometimes unpronounceable, herb.
A smart novelty retailer would do well to stock the newest and most exciting supplemental products that ride the wave of consumers clamoring for the next inexpensive herbal pill or hot new lubricant that promises to add a little magic to their lovemaking. Simply, these items are selling. Big time.
A GROWING MARKET SHARE
How big? According to the Nutrition Business Journal, since 2001 sales of supplements marketed as natural sex enhancers rose from an estimated $100 million to approximately $400 million in 2006. Some industry insiders, like Rodney Tallman, CEO of Life Span Labs, put that figure closer to $500 million today. At the Adult Novelty Expo held in July, a growing number of companies touted new herbal products meant to enhance sexual performance. One company, Body Action Products, even introduced a supplemental gum, Vive, in three varieties: Male Climax Control, Breast Enhancement, and Male Enhancement. One flavor (Cool Mint), three ways to freshen more than just one's breath for that big date Friday night-and no pesky prescription required.
Like most responsible manufacturers who understand a healthy customer is a happy (and potentially returning) one, Joe Jennings of Body Action Products did his research and chose to play it safe when he introduced his new line of supplements: "We really investigate our ingredients, formulas, and any side effects. If we find anything negative, we don't use it...and we never claim to treat, cure, or prevent any disease."
IN THE KNOW
But how safe are most of the supplements widely available today...or flavored lubes or anything potentially ingested for that matter? And how does a retailer or consumer know what to look for when there are so many products that make phony claims, or worse, may contain potentially harmful ingredients? These questions are coming up increasingly as crackdowns on a few shady herbal supplement makers threaten the livelihood of largely law-abiding manufacturers in the sex supplement business that make it a point to work within established health guidelines, avoid lofty or specific medical claims, and emphasize the fun, novelty aspect of these mostly harmless products.
In July 2008, Jack Distribution, LLC, announced a voluntary recall of select lots of Rize
2 the Occasion and Rose 4 Her capsules that were potentially spiked. The recall announcement came after FDA labs found lots of the product manufactured and packaged in 2007 contained "potentially harmful, undeclared ingredients"-specifically thiomethisosildenafil, an analog of sildenafil.
According to the FDA documentation, "This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance."
Other popular sex supplements, like Stamina Rx and Vigor 25, have faced governmental warnings, recalls, or expensive lawsuits due to spiking or unlawful claims. But not all herbal supplement and novelty lubricant manufacturers are grinding up little blue Viagra pills and sneaking the stuff into their products. In fact, most are extremely concerned about consumer safety, work within FDA guidelines, and believe staying off the FDA's radar means staying in business. As Lorne Caplan, ND, on the scientific advisory board to pheromone producer Master & Mistress, puts it bluntly: "How are you going to fight the FDA?"
PLAYING THE GAME
When it comes to facing expensive recalls and lawsuits, most manufacturers choose a similar path of least resistance: compliance. Kathryn Hartman, sales and marketing director for Nasstoys, makers of popular Spanish Fly, states simply, "We follow the guidelines."
"Even though our products don't tout FDA approval, all ingredients are approved and from an FDA-approved laboratory," she adds.
Dennis Paradise of Paradise Marketing is quick to inform consumers and retailers alike that the issue of FDA approvals also involves tricky semantics: "The FDA doesn't approve anything. They do not say, ‘We approve this product; we don't approve that product.' Certain products are required to be submitted to the FDA to meet standards."
These standards aren't reserved exclusively for herbal supplements. For example, Paradise explains, "Every condom sold in the U.S. must meet or exceed certain criteria. ...If the FDA regulates a product, compliance is not optional."
Pavel elaborates: "FDA compliance, in the broadest sense, means that both your business and the products you sell meet the requirements of the Federal Food, Drug and Cosmetic Act and its implementing regulations. This may involve very little beyond ensuring and documenting that your products and their ingredients are safe and suitable for their intended use or it could involve registration, review, or even a full premarket approval process."
"Manufacturers don't have a choice whether or not to comply with the FDA. [FDA compliance] should matter [to consumers]. I don't think [consumers] think about it. If they take something and it itches an hour later, then they think about it. It's the itch, not the law, that triggers the thought," emphasizes Paradise.
Christopher Schaaf, general manager of Empowered Products who makes the popular Gun Oil and Pink personal lubricants, says applying to meet certain FDA standards can be an expensive, lengthy and complicated process, requiring an outlay of upwards of $50,000 in cash for their company.
Empowered Products is currently in the process of getting FDA approval to make condom compatibility claims for its line of premium lubricants. "The FDA regulates the use of the word ‘condom.' There are two types of lubricant [categorizations]. A cosmetic lubricant does not allow you to make condom claims. Those categorized as a medical device can make condom latex compatibility claims," meaning the lube can say it's safe to use with condoms -a claim popular with consumers concerned about using condoms to promote safer sex and looking to buy a condom-compatible lube. "If we claim our lubricants are condom compatible, in order to make those claims, we have to have FDA approval," Schaaf says.
Fortunately, for Schaaf and his company, the rigorous standards process is nearly over: "It's been a year-long process to undergo product testing and prepare our submission for FDA clearance."
Schaaf elaborates on what the company had to go through prior to submitting to the FDA: "a battery of tests, including shelf-life stability, irritation, antimicrobial preservative effectiveness testing, condom compatibility, sensitization, and cytotoxicity. If [the FDA feels] the testing isn't sufficient, they will not clear your application and tell you what is non-sufficient or what must be redone."
And it doesn't stop with testing. He adds, "Passing your testing is the first major hurdle.
Any failed tests may earn you a rejection, as will data analysis not put in the correct format. You may have to resubmit everything."
Schaaf lauds the adult industry for keeping a sharp eye on consumer safety: "The adult industry is the most self-regulating I've ever worked in; we're under a microscope." This focus on safety, Schaaf feels, is both about safety and smart marketing choices. Making condom compatibility claims, he says, is "definitely a marketing tool as well as a safety tool for the consumer."
For retailers, making such an approved claim makes it easier to service customers properly-and safely. "A customer may ask if this [lube] is safe with a condom. If a retailer is asked this question, they should be able to just look at the bottle and say whether something is safe for use with a condom," he explains.
Pavel shares some additional wisdom for retailers wondering about the safety of these products and the FDA's role in the industry: "I think from a retailer's perspective, the best way to take advantage of the FDA's oversight is to be educated as to which products you sell are regulated by the FDA and why. A general familiarity will allow retailers to better serve their customers."
WHAT ABOUT RETAILERS
"Generally speaking, most retailers do not have to worry about FDA regulatory legal issues from an enforcement perspective. Most of a retailer's concern should be focused on customer relations and product liability issues that may arise from the sale of non-approved or recalled items," says Pavel.
What should a retailer do in case of a recall or FDA warning? "In case of a recall, retailers should be diligent in responding to the manufacturer's, wholesale distributor's, and FDA's instructions. Keep very good records and document your actions and any complaints by customers. In addition to the FDA, private lawsuits are always a concern. While product injury lawyers will generally go after the deepest pockets, stocking quality products may help you avoid having your shop added to a lawsuit because of a product you sell," Pavel advises.
When it comes to safety, Paradise agrees that retailers have a responsibility to keep their customers safe and should take an active interest in the products they stock. "If [the retailer] doesn't worry about [consumer safety], that's not a store I'd buy from. He needs to know the stuff he's pushing across the counter doesn't hurt anybody," he says.
Even though retailers share part of the responsibility for product safety, Schaaf is quick to point out the burden of safety is on manufacturers to consider consumer well-being.
"If I make [an unsafe] claim, I'm liable for a lawsuit. Manufacturers have the most liability; we're the ones that have to carry product liability insurance," Schaaf explains.
Hartman adds that knowing where a product is made might help retailers to distinguish what products are safer than others: "As far as liability is concerned, you want to be able to trace something. Our customers can be assured that if a specific batch needs to be traced, we can trace it back to a specific lab and ensure that it's been FDA approved."
With new supplements and novelty products coming out on a constant basis, and few ways for the average retailer and/or consumer to know what is truly safe, Hartman feels a company or product's longevity may also be a reassuring sign that a product is harmless: "Our customers really enjoy using our products, and they've been doing so for 30 years."
Manufacturers and retailers in the adult novelty business would be wise to take heed of the growing attention the FDA is showing the lucrative erotic supplements market. As the old saying goes, an ounce of prevention may be worth a pound of cure. Complying with regulations and ensuring customer safety now is critical to avoid expensive recalls and potential lawsuits later.
This column does not constitute legal advice but, rather, serves to inform readers of legal issues and provide an editorial comment on legal developments and trends. Readers who believe anything reported in this column might impact them should contact their personal attorneys.
