Are Your Dietary Supplements FDA Approved ?

You’d be surprised to learn that how many people think they are. FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed. The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to market.

If the dietary supplement contains a NEW ingredient, manufacturers must notify FDA about that ingredient prior to marketing. However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness.

Manufacturers are required to produce dietary supplements in a quality manner and ensure that they do not contain contaminants or impurities, and are accurately labeled according to current Good Manufacturing Practice (cGMP) and labeling regulations.

If a serious problem associated with a dietary supplement occurs, manufacturers must report it to FDA as an adverse event. FDA can take dietary supplements off the market if they are found to be unsafe or if the claims on the products are false and misleading.

When the FDA updated some of its guidelines around dietary supplements last year, many critics of the nutraceutical business were pleased to see a bit more regulation in an industry that enjoys surprisingly little oversight. Focusing on premarket safety, the new guidelines state that manufacturers/distributors must notify the FDA at least 75 days before beginning to market a dietary supplement that contains a new dietary ingredient.

However, that seems like a relatively small measure, especially when you consider the massive amount of regulation that the FDA subjects the pharmaceutical industry too. In an article demystifying the differences, Felicia D. Stoler of Fox News Health explains, “In a general sense, dietary supplements fall under the purview of the FDA – where there are regulations that pertain to labeling and “claims.” However, when it comes to the measurement of safety and effectiveness – as prescription drugs must do – it is not the same. The FDA does not ensure potency, purity or biologic activity of the ingredients in dietary supplements. There is no registration or clearance by the FDA before a dietary supplement goes on the market.”

Perhaps one of the most shocking differences is that, while drug makers are expected to maintain strict pharmacovigilance, reporting adverse effects from supplements is entirely voluntary. Writing for Salon, Lynn Stuart Parramore says the lack of standards opens the door for unethical business practices: “Some who promote ‘alternatives’ — the manufacturers, distributors, and sellers of supplements, aka Big Herba —take advantage of regulatory loopholes, public distrust of the medical realm, and consumer confusion to push pills and potions that may do absolutely nothing for your health, or worse.”

As Harvard Health’s Patrick J. Skerrett notes, according to the terms of the Dietary Supplement Health and Education Act of 1994, supplements with established ingredients (i.e. those that had been sold in the U.S. before ‘94) can be marketed without any evidence that they are effective or safe. “Compare this hands-off approach with the strict rules and regulations for drugs,” Skerrett writes. “No drug can be sold until the FDA has proof clear proof that it is safe and effective. And every FDA-approved drug must be made to strict specifications.”

One can imagine that some pharmaceutical drug makers might fume over this situation. After all, while they take on the serious and costly work of running intensive drug trials and conducting post-market surveillance, dietary supplement makers can just grind up a few plants, put them in a bottle and then forgo responsibility. Except for one thing: the reality is that even though the regulations on pharmaceuticals and nutraceuticals are as different as night and day, the companies creating them are not.

“Increasingly, Big Pharma and Big Herba are indistinguishable,” claims Parramore. “The very same mega-companies with gigantic chemical labs that make drugs are cooking up vitamin and herbal supplements labeled with sunny terms like ‘natural’ and ‘wholesome.’ Pfizer, Unilever, Novartis, GlaxoSmithKline and other big pharmaceutical firms make or sell supplements.” While she does acknowledge there are a few small companies still in the mix, Parramore says they represent a tiny amount of the total sales in the $23 billion-a-year supplement business.

Many of these pharma companies have made the foray into supplements because it plays to their strengths while being far, far cheaper than drug development. Meanwhile, though, there are other large companies coming at it from a different direction. Nestlé has established a subsidiary, Nestlé Health Science, which, according to STAT, “employs 3,000 people globally and brings in annual revenue of about $2 billion. The big drivers: high-protein nutritional shakes sold under the Boost brand, and shakes and soups marketed under the Meritene brand as reducing ‘tiredness and fatigue,’ among other benefits.”

And now that they have had that much success with just shakes and soups, Nestlé Health Science aspires to get in the pharmaceutical game. They’re readying to start late-stage human trials for a “medical food” that targets Crohn’s disease and they want to do testing for a drug compound (licensed from a biotech company) that treats ulcerative colitis.

As big companies pursue both drug development and nutraceutical manufacturing, it seems the lines between supplements and pharmaceuticals will continue to blur. In a Forbes interview conducted by Joanne Belbey, medical expert Dr. Kevin Campbell suggests that the two really shouldn’t be approached so differently when it comes to oversight. “Supplements are the ‘Wild Wild West’ in terms of regulation, whereas I consider pharmaceuticals over-regulated,” he says. “It’s two wide extremes. I’d like to see something more in the middle with more regulation of supplements to protect the consumer and more meaningful streamlined regulatory action on the pharmaceutical industry.”