They seem determined to treat supplements like drugs. Problem is, no one will pay billions for FDA approval, and most of your supplements will disappear from the shelves. Major Action Alert!
New York Attorney General Eric Schneiderman has again upped the ante in his assault on the supplement industry. We recently reported how Schneiderman used a poorly designed — and now completely discredited — test to challenge some herbal supplements. But egg on his face hasn’t slowed him down.
Recently, he sent a letter co-signed by thirteen other AGs asking Congress to “launch a comprehensive congressional inquiry in the herbal supplement industry” because “a current state investigation has raised serious concerns about the marketing and safety of the herbal supplements regularly consumed by millions of Americans.” As we and others have shown, the only concerns the investigation actually raised were about the scientific incompetence of the New York AG’s office. Even a recent compromise with GNC, one of the companies Mr. Schneiderman investigated, which agreed to voluntarily begin using DNA barcoding on its products, was apparently not enough to slow down the crusading AG.
The letter calls for certain congressional subcommittees, in conjunction with the FDA, to conduct an investigation that would consider tightening supplement regulations, including new rules regarding ingredients, labeling guidelines, and manufacturing practices — all supposedly to enhance quality assurance, in an industry that already has an exemplary track record for quality — and ramping up existing controls, supposedly to ensure the safety and effectiveness of finished products sold by retailers.
In itself this does not sound objectionable. But keep in mind that virtually all of what they’re asking for is already covered by existing federal regulations. Supplements are a highly regulated industry. The only remaining regulation they could possibly have in mind is to subject supplements to the multi-billion-dollar FDA drug safety and efficacy approval process. The NY AG knows full well that no one will ever pay for that since supplements, being natural, cannot generally be patented.
Let’s not forget the following:
- Current good manufacturing practices (cGMPs) for supplements could not be more stringent. Laws to guarantee safe products are already on the books, and it is up to the FDA to enforce those laws. FDA memos, retrieved through Freedom of Information Act requests, show that the agency has, at least in the past, deliberately refused to enforce laws in the hope that something would occur which was so bad that current supplement law would be abandoned in favor of a drug-type regulation scheme. If once in a great while some bad actors fail to meet current high standards, and the FDA fails to hold them accountable, this should not reflect on the entire industry. The FDA already has the power it needs, so passing more regulations would simply be redundant.
- The testing regimens which the supplement industry are held to under cGMPs are one reason that supplements have such a proven track record of safety — more so than food, not to mention FDA-approved pharmaceuticals. One report from the Government Accountability Office found that there were an average of 1,575 adverse event reports (AERs) related to supplements per year between 2008 and 2011. When you factor in that about half of Americans (157 million people) take supplements every day, this means that only one-hundredth of one percent of all supplement users ever experience any problems at all. It is also worth noting that AERs are not concrete evidence of supplements being a factor in an adverse event, but simply a possible correlation. By contrast, in 2008, there were 526,527 AERs from pharmaceuticals — 488 times more than the number of supplement AERs. Our counterparts at ANH-Europe found that UK residents were about as likely to get struck by lightning as die from taking dietary supplements.
- Because cGMPs already cover the lion’s share of what the AG’s letter is asking for, what Mr. Schneiderman and the other AGs really seem to be after — as evidenced by their use of specific language like “safety and efficacy” — is a regulatory regime that would subject supplements to the same pre-approval process that pharmaceutical drugs must go through. An economic analysis ANH-USA conducted in response to a less-stringent regulatory proposal than the one Mr. Schneiderman seems to be asking for found that between 22,240 and 41,700 dietary supplements would disappear from the market as a result. This hurts consumers far more than it helps them.
Given these considerations, one wonders what is motivating Mr. Schneiderman and his coalition of AGs in the first place. Is he trying to curry favor with the drug industry, in the hope that this will help him finance future campaigns — for governor, perhaps? There will be a huge political upside for him if Congress decides to act. It will create a media frenzy, with the NY AG’s name headlining all the stories, without his having to make a viable case for his position —something he has so far been unable or unwilling to do—or explain how any of this benefits New York’s taxpayers.
The possibility exists, of course, that he is simply misinformed. This is disturbing, since his initial tests have been completely invalidated. With no safety violation and no evidence of fraud, the NY AG’s office might have withdrawn its case and issued a mea culpa. If the entire process was predicated on faulty data, which appears to be the case, the AG needs to explain how his office could have acted so rashly and with such gross incompetence. Instead — and without a scintilla of scientific evidence or a single public health violation—he has redoubled his attack.
One thing is certain: consumers must speak out in a clear voice to tell congressional leaders not to cave in to these specious demands and to preserve consumer access to important dietary supplements.
© 2015 Alliance for Natural Health USA (ANH-USA), CC BY 3.0