There’s a saying in the supplements world when it comes to pills marketed as supporting the structure or function of a man’s penis: If the pills work, they’re adulterated. That’s because only sildenafil (Viagra) and its pharma analogues work on demand, whereas true supplements might work to gradually dilate blood vessels, sending more blood throughout the body quicker and, over the course of a few weeks, a man might notice an improvement.
This is important because there are three classes of dietary supplement products that have attracted the keen interest of the U.S. Food and Drug Administration (FDA): muscle-building products, weight-loss products and those targeting erectile dysfunction (diabetes is a peripheral fourth).
You might call these areas the sandboxes of the irresponsible industry.
To keep things on the up and up, the New Hope Standards Department has a unique role in the industry. New Hope Natural Media (disclosure: us) is the only media company to vet booth exhibitors at every one of its shows, and every print ad in every one of its publications.
The Standards staff applies a keen eye to all literature being dispensed at shows to make sure the direct claims comply with FDA regulations. These are mostly along the lines of making drug claims—marketing products as being able to diagnose, treat or prevent diseases. The FDA says that only drugs can do that (even when supplements haven been shown in studies to do so, but that’s another story).
Why standards matter
Last fall, in another industry ingredient supply show one exhibitor was openly marketing steroids. That kind of stuff would not happen at a New Hope-produced event.
When materials are found to be in violation, the Standards team works with companies to help them become compliant.
“Our standards program is in place to create the highest-quality tradeshow, and secondly to help protect exhibitors from enforcement action from FDA and FTC,” said Steve Taormina, Standards Director. “We have an ongoing relationship with FDA. Officials are welcome to attend and speak at our tradeshows, and we let exhibitors know they’re going to be there. In the spirit of improving the industry, we think it’s best that everybody’s compliant.”
Raising the bar even higher
The New Hope Standards Department is now embarking on a new phase in its diligence and quest for quality all the way around in the industry. Whereas originally the task was to vet all literature and labeling at shows, they now have begun testing finished products.
“The real focus is on the irresponsible section of the industry,” said Taormina.
Standards has an arrangement with NSF to test products for adulteration. Any exhibitor may be subject to being lab-tested. Thus far, the only products that have been tested have been selected erectile-dysfunction products. One in three did not pass.
You want fodder for the feds to clamp down on supplement regulations? Keep it up (so to speak).
“We have only tested for adulteration for PDE-5 inhibitors—sildenafil knockoffs, the broad category of analogues of sildenafil that are being found in supplements. Viagara is the brand name,” said Taormina. “When nefarious suppliers patent a pharmaceutical, they will oftentimes patent a number of analogues, which might then be pirated.”
Besides rank piracy of pharma ingredients into the supplements world, there is the real issue of human safety because oftentimes these knockoff products contain much higher levels of the pharma actives than can be found in the prescription pill.
“Our Memorandum of Understanding with NSF is critical because NSF has some of the best and most thorough testing of labs out there for these adulterants, meaning their assays can show results for more analogues than other labs,” said Taormina.
In such cases where companies are found to be forgers, and summarily dismissed from exhibiting at shows, their booth is released without charging them a cancellation fee.
“We don’t take money from companies that don’t meet our standards in that context,” said Taormina. “There’s the victory for the New Hope Standards department, and that’s good enough.”