Take Your Premarket Approval and Shove it

September 3, 2008

7 Min Read
Take Your Premarket Approval and Shove it

Boy, am I glad Berkeley and its founder, Steve Warshak, got in big trouble. These types of "supplement" providers do so much damage to the public image of the greater, responsible dietary supplement industry. As usual, the media inflames.

While the media is s-l-o-w-l-y accepting the notion that supplements ARE regulated—even more so today than 10 years ago—they still want to treat supplement like drugs.

A piece in the LA Times, "Supplement Makers Need Stricter FDA Oversight," by David Lazarus, starts off his argument against current dietary supplement regulation with a few valid points/concerns. There undoubtedly are a few quality control issues facing the dietary supplement industry, from contamination to irresponsible marketing. The former involves the FDA, the latter the FTC. FDA has more to do with product safety, while FTC has more to do with fair, responsible business operations such as advertising and marketing.

It was the FTC that went after Berkeley et al. for business practices related to its undisclosed automatic charging policy. There are unethical businessmen trying to profit from any successful industry. Doesn't make it right...or acceptable.

I offer two important developments in dietary supplement regulation from the past year or so, one cited by Lazarus in his article, that will help situations like the case with Berkeley. Adverse event reporting and good manufacturing practices (GMPs) were both supported by the supplement industry, which had been calling for such regulation for years, since DSHEA even.

As Lazarus points out, adverse event reports (AERs) can help alert the feds of any growing trends. There is a similar system in place for pharmaceuticals, which tend to have way more side effects than most supplements. Ahhh, ephedra then. Lazarus ignores the thousands of years ephedra has been used safely and links the herb to "more than 100 deaths."

This, to me, brings up an important issue that, I believe, is tied to the ephedra mess. Ephedra was popular in weight-loss and sports products, as well as some allergy formulas (a la its pharma cousin pseudoephedrine). The opportunity for misuse runs high here.

If properly labeled and used as recommended, the risk for danger appears very low. As herbal expert Mark Blumenthal has reported, ephedra products "are relatively safe when they are properly labeled and used for appropriate purposes ... people need to heed warnings and follow the directions on the label."

I contend that even if ephedra were to go through pre-approval for OTC status, people would take it in the same way as they did when it was freely available as a dietary supplement. How would this change the outcome?

When people want results, the temptation to misuse or overuse a product goes up. Using mainstream media's own reporting, USA TODAY published this article in 2007, detailing the alarming overuse of legal drugs like OxyContin and Ritalin. In a NY Times article on OTC weight drug Alli, eight-loss doctors touted the drug's safety when used as directed, but expressed concern over potential abuse. Whenever anything is over the counter, there is a potential for abuse, and I have no doubt that that’s going to happen,” said Jana Klauer, a weight-loss expert and nutritionist from New York. “I think people who don’t really need it will take it. People who don’t need to lose weight will take it.”

There is nothing to stop people from misusing a substance, if they are determined to overdo it. In the case of ephedra, the back-and-forth ban of ephedra was based on a risk-to-benefit assessment, meaning FDA claimed the potential dangers of ephedra outweighed the health benefits. Despite objecting to the ban during the hearings, now that the ban has been upheld in court, the responsible supplement industry is adhering to the law.

Next up for Lazarus and his regulation argument is Airborne. Make no mistake, marketing is a big part of why Airborne got so big. Its formulation notwithstanding, celebrity backing to the degree seen with Airborne (the "Oprah" effect) will tap into the fame- and gossip-starved culture in which we currently live here in America. If you look at the case brought by FTC, Airborne was popped for marketing gaffes and misleading advertising claims, not for being unsafe. Thousands or millions of customers took to the marketing of the product, and some seem to have experienced benefits. Some, it would seem, did not. Given the size of the judgment, cases like this serve as mighty big deterrents to any companies looking to take similar marketing advantage of consumers. FTC did its job.

Here is where I take one big issue with Lazarus. "How's this for a rule: If you put something in your mouth, and if that something is purported to improve your health or well-being in any way, then it needs regulatory approval before being marketed."

When I eat an apple or piece of whole-grain bread, I am expecting it to deliver its purported benefits to my health. Same for spinach or lettuce. None of these need regulatory approval before marketing. Yet given recent contamination crises, eating food comes with the risk of salmonella, e. coli or any number of health dangers.

Maybe this is a bit like comparing apples to oranges, but supplements have long been considered as foods, seeing as how they supplement food. This connection works well for vitamins and similar nutrients, but the situation gets a bit fuzzier when it comes to herbs, apparently. Even sports nutrition and weight-loss dietary supplements are intended to support the diet, but they can be misused, for sure.

While once regulated just as foods are, supplements now have their own regulations, their own oversight. It started in 1992 with DSHEA (Dietary Supplement health and Education Act) and the game plan the law established. Today, with GMPs now finalized (by FDA) for dietary supplements, manufacturers are held to manufacturing and handling standards that should eliminate or greatly minimize the risk of contamination (heavy metals etc.) and other product content concerns. The FDA has every right to inspect facilities for compliance. If a company is operating outside of the GMPs, FDA should be closing them down, just as the feds do with illegal pharma operations.

Premarket approval for dietary supplements is unrealistic and unnecessary. It would require way bigger government than is already in place. In utopia, I don't see why premarket approval would be a burden, assuming money were no object and time were of no essence. Still, the few problems seen with dietary supplements (ephedra, Berkeley, Airborne, etc.) are aptly addressed by FDA, FTC and their reams of regulation over supplements, including DSHEA, GMPs and AERs.

Lazarus ends his editorial with: "The supplement market is awash in snake oil. If that's not what we pay our regulators to protect us from, what is?"

The dietary supplement industry acknowledges there are some rogue participants taking advantage of ill-informed consumers and a weakened FDA. However, it's not fully the government's job to protect us from "snake oil" (so long as the products don't promise things they can't deliver...then FTC steps in.) Consumers have many high-quality choices, but often opt for the cheaper options, which is generally where the snake oil operates. They also fall for wild claims and quick fixes, especially in the weight-loss arena. Do I need to mention the phen-fen fiasco? How about Vioxx? That made it to market, despite premarket approval. So did spinach, tomatoes and jalapeno peppers. By the way, all these contamination and safety issues point at FDA failing to do their job efficiently, not the lack of additional major legislation to prevent problems. PREMARKET APPROVAL HAS NOT RID THE HEALTH MARKET OF SAFETY ISSUES. That's asking too much.

The market for dietary supplements is improving, as the industry and regulators work to push out the rogue players, and as consumers begin to take a more careful approach to the supplements they buy and use. America has always supported the notion of "buyer beware," no matter how regulated an industry is.

The dietary supplement industry is well-regulated by appropriate legislation. Enforcement of said legislation is the real key, especially going forward with the recent AER and GMP rules. It remains to be seen how many adverse events supplements are linked to over the next years. Industry is confident these numbers have been and will continue to be low. Let's not try to over-regulate to protect consumers from an inefficient federal government (namely FDA) and handful of cases of poor product choices and misuse.

To my fellow consumers, I say, take your health seriously. If you plan to ingest something (exotic fruits, OTC products, drugs, supplements, etc.) to improve your health, your immunity, your physique, your performance, take the time to ask questions, research products and buy from a reputable retailer and brand. Use products only as directed, and only for intended uses. It's common sense, whether it's an OTC product, prescription drug or dietary supplement.


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