Dietary Supplement Quality, Safety and Regulation: The Real Story

As the former Director of the Dietary Supplement Division at the Food and Drug Administration (FDA) charged with enforcing the federal government’s regulatory regime that ensures dietary supplements in America are safe, I am particularly interested in the recent New York attorney general’s enforcement action that led to the request for removal of selected herbal supplements from retailers’ shelves in one of our country’s largest states, as well as the formation of a coalition with other states to broaden the investigation into these products.

More than one month since the attorney general’s cease-and-desist letters were sent to retailers, however, there are many more questions than answers.  And as the current CEO of the Natural Products Association, the nation’s leading trade association for dietary supplement manufacturers, retailers, and suppliers, I hope the attorney general will change course and bring transparency to the process and research that led to this dramatic request.

To begin, we must first review the facts on dietary supplement regulation by the FDA, the science and methods used as the basis of the attorney general’s study of these products, and supplements’ positive role in health.

Over 180 million Americans take supplements.  And supplements are just that — an addition — and should never be used as a substitute for a good diet.  But let’s face it, most of us don’t eat enough broccoli or consume enough fish to derive a sufficient benefit from eating healthy foods alone.  Many of us, myself included, take a multivitamin or other supplement safely each day, often at the direction of a doctor.

One reason dietary supplements are used safely daily is because they are regulated by the FDA.  This might come as a surprise to those who have seen the recent inaccurate media coverage on supplement industry regulation, but it is a cold hard fact and something that can be easily checked.  The FDA has the tools to enforce against unsafe products. The FDA can and should pull any product off the shelf if it is determined to be unsafe, and the agency has done just that in several cases.  Not only can the FDA pull a product that has already gone to market, but the agency can also block, and has blocked, the movement to market of products it determines might be unsafe for the general public.

The FDA may also enter into consent decree agreements with firms to stop the sale of products. More important to this story, the FDA has and continues to enjoin manufacturers, shutting them down or seizing products that do not meet the current Good Manufacturing Practices (CGMPs), the required quality standards all dietary supplement manufacturers must meet. All of these actions are in place to protect consumers from the bad actors posing as legitimate dietary supplement manufacturers. The FDA clearly regulates dietary supplements, and if it has seen a problem like the one purported by the New York attorney general, the agency has been active in addressing it and we applaud those enforcement activities.

The issue of the methodology used in the New York attorney general’s study is a separate but equally important issue.  First, it is critical to note that the FDA does not use this particular study method because it seeks to prove the absence of DNA, which is very difficult especially when applied to botanical extracts, the exact material being analyzed by the attorney general.

FDA scientists know that if a botanical is extracted, the DNA is no longer intact, so it makes perfect sense that the DNA markers, indicative of particular botanicals, in the products the attorney general tested were not present.  In other words, the attorney general’s hypothesis is akin to testing the integrity of a vessel with the capacity to hold water and then saying the vessel is useless or broken because there was not any water in it.  It is surprising and risky for the attorney general to use a methodology that is well known and commonly rejected by the FDA as the basis for such action.  At the very least, the attorney general should make this study public and make the research available for peer review. At this point, the attorney general has not done so.  That should tell us quite a bit. Because testing for the absence of DNA in botanical extracts is not a gold standard, the test methods adopted by the New York attorney general should have used a confirmatory method.

The report also suggests that other plants were found that were not supposed to be there, which could possibly lead to allergic reactions. DNA methods amplify genetic material, making DNA authentication a qualitative rather than quantitative method. If small amounts of genetic material were present, using a method to make multiple copies of genetic material would not be the method of choice to tell whether it contained trace or significant amounts. Setting aside what has already been said about the study methodology, if there were problems with the product like undeclared allergens, the FDA has the tools for the job and would have identified the problem per the Dietary Supplement and Nonprescription Drug Consumer Protection Act.

This law requires manufacturers of dietary supplements and over-the-counter drugs to report all serious adverse events, such as an allergic reaction, to the FDA. This bipartisan law ensures that the FDA receives good and timely information about any safety concerns associated with these products, so those concerns can be investigated, and appropriate action can be taken to protect consumers.

What’s more, the FDA is not the only agency that regulates supplements.  The Federal Trade Commission enforces the law barring false claims on labels and has issued millions in fines and penalties, including prison time, for criminal activity.

An unregulated industry?  Hardly.  And these are just some of the ways in which the federal government regulates the dietary supplement industry.

The real risk would be to scare the American people into thinking that botanical dietary supplements and other safe natural products, when used properly and with the consultation of a physician, are somehow detrimental to their health or are of substandard quality.  On the contrary, these products, are well-made by responsible manufacturers, and have and should play an important role in improving America’s health, nutrition and wellness.



Dan Fabricant is CEO and Executive Director of the Natural Products Association (NPA)

Morning Consult