A few weeks ago, the Food and Drug Administration (FDA) released its latest guidelines for the nutritional supplement industry, and the news is not good for health-conscious consumers. In response to this long-awaited revision of FDA guidance rules for new supplements, the Alliance for Natural Health (ANH) is calling for an urgent “highest-level action alert.”
Dietary Supplement Regulation in the US
Back in 1992, the FDA published its Task Force Report on Dietary Supplements, which included the statement that dietary supplements represented a “disincentive for patented drug research.” This report, plus the news that the clinic of medical nutritionist Jonathan Wright, MD, had been raided at gunpoint, sent shockwaves through integrative doctors’ offices and health food stores across America. As the ANH declared, “News of this raid turned out to be the shot heard ’round the world for health freedom.”
In response, Congress received over two million letters of protest and passed the landmark Dietary Supplement Health and Education Act (DSHEA) in 1994. The law was intended to expand consumer access to nutritional supplements. However, certain provisions of the law were not clear, and subsequent FDA guidelines have actually made things worse.
In 2011, the FDA released guidance rules which threatened to cripple —if not eliminate—the supplement industry. According to the Alliance for Natural Health, “an economic analysis at the time by an Emory University professor estimated that the FDA’s outrageous interpretation [of DSHEA] …would have meant the elimination of tens of thousands of supplements from the market, an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies…, and the loss of between 55,270 and 104,475 jobs in the supplement industry.”
When supporters of ANH flooded the FDA with nearly 150,000 pages of comments, the FDA agreed to review its guidance rules. Proponents of nutritional supplements had been waiting for the agency’s updated draft ever since. Well, it has just been released, and it is mostly the same old story.
What’s Wrong with the New Guidelines?
The latest draft of regulations governing new dietary supplements, arriving twenty-two years after the passage of the DSHEA legislation, and further delayed after the disastrous first draft in 2011,was finally published in August. It is a little better in some respects, but the biggest problems remain, and it still represents a dire threat to the nutritional supplement industry and consumer access to supplements.
One of the main issues facing the supplement industry has been confusion over how to comply with the FDA’s new dietary ingredient (NDI) provisions. Essentially, what we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements. By making that virtually impossible, the FDA is threatening consumer access to thousands of dietary supplements. At the core of the problem is the difference between INDs and NDIs.
An IND (investigational new drug) refers to a new drug, while an NDI refers to a new supplement. Under current law, if an IND application is filed for an ingredient — that is, an ingredient being studied for use as part of a new drug — that ingredient (even a natural one) can no longer be produced or included in a supplement if an NDI has not previously been accepted.
This has already happened in the case of pyridoxamine (a form of vitamin B6), the result of which was that this valuable form of natural B6 is no longer available as a supplement. According to the new guidelines, the FDA explicitly states that even when an IND is rescinded or does not lead to a new drug, the supplement form is still banned.
As a recent email I received from the ANH laments, “Imagine the mischief this could cause when some enterprising drug company decides to corner the market on a whole list of [natural] ingredients to keep them out of the hands of supplement formulators forever more. This could very easily be done under this guidance.”
ANH continued, “Probiotics—the “good” bacteria which our bodies, and in particular, our immune systems, absolutely depend on—could also be on the chopping block… Is it a coincidence that Big Pharma is now very interested in producing its own versions of this product? Having probiotics subject to prescription—or costing $100 a bottle—will be a disaster for the health of Americans….”
The FDA also requires additional safety studies on new supplements if the target population changes. If a history of safe use has been established with adults, but a substance will be used in a dietary supplement marketed for young children, the FDA would require another NDI notification. These safety requirements are not even expected of drugs! Most drugs–even dangerous antipsychotics, antidepressants, and stimulants—are not subject to population-specific safety studies in order to be used on children or the elderly. This makes the FDA’s new position on supplements especially hypocritical.
As stated in the ANH communication, “Why would the FDA do this? Clearly these are the actions of an agency looking to restrict the supplement market and remove as many products as possible in as many ways as possible—even though it openly defies the intent of Congress in passing DSHEA, which was meant to expand consumer access to dietary supplements.” The FDA seems to be working, as usual, on behalf of the drug industry.
What Can You Do?
Action Alert! It will take a huge effort on all of our parts, but we need your help to stop this right now. Write to your congresspersons immediately to protest this revised guidance that threatens our access to supplements. Register your opposition and dismay at what the FDA is, once again, trying to do in its never-ending war against dietary supplements.
The Alliance for Natural Health wants to help you to send your message immediately. If you
click here, a prepared version of what you read in this article will be automatically sent to your lawmakers.
ANH is right about the Food and Drug Administration: “The agency, under the guise of protecting us, is really just protecting its funder, the drug industry, and is throttling any chance of innovation and improvement in supplements. This is so corrupt that it is hard to understand how Congress can continue to turn a blind eye to it, but of course Big Pharma funds political campaigns as well.”
The newest NDI guidance needs to be amended YET AGAIN to protect the public’s access to supplements and to reflect what Congress originally intended in DSHEA: to expand, not restrict, consumer access to supplements. The new guidelines are just one more attack in the FDA’s relentless war on supplements that is clearly intended to benefit the pharmaceutical industry. By now, it should be evident that the FDA cannot provide credible oversight of the supplement industry. This is a classic example of the fox watching the hen house. Another regulator is needed.