New Prescription Drugs Safety Issues

New drugs have a 1 in 5 chance of causing a serious adverse reaction after they are approved. Properly prescribed medications cause 128,000 deaths in the U.S. alone each year, making them the 4th leading cause of death; 1.9 million hospitalizations and 2.74 million serious adverse drug reactions are also courtesy of prescription drugs. On the other hand, an investigation by the U.S. National Poison Data System revealed zero deaths from dietary supplements in 2013. And out of the over 150 million dietary supplement users in the U.S., less than one-tenth of one percent will visit the ER as a result. So why is it that the FDA’s recently published revisions of “the guidance of new dietary ingredients” include safety requirements and red tape that is more stringent than what is required of the pharmaceutical companies? We wish we had a good answer.

Though most of us would agree that the dietary supplement industry should be regulated at some level for the purpose of assuring safe and effective products for consumers, it is clear that the FDA is not fit for this job – especially in light of the revisions released in August. When the Food & Drug Administration published its Task Force Report on Dietary Supplements in 1992, it was difficult to believe that the organization was acting primarily out of concern for the American public. The document made bold statements such as “disincentive for patented drug research” when referring to the supplement industry, resulting in the agency’s motives coming under fire.

Ultimately, the outcry to Congress (in the form of roughly 2 million letters) from both the public and natural health advocacy groups, led to the enactment of the 1994 Dietary Supplement Health and Education Act (DSHEA). Congress hoped this Act would help to protect and even expand consumers’ access to safe dietary supplements. The FDA, however, ignored Congress and the public and proceeded to put guidelines into place that have done – and will continue to do – the exact opposite of what Congress had intended. This conclusion was not just speculation from the public. In 2011, when the FDA finally published the first draft of the guidance rules for new dietary ingredients (which basically refers to new supplements), Congressman Peter Roskam (R-IL) spoke up and accused the FDA of reversing the intent of congress when they passed the 1994 DSHEA. Overall, the guidelines would make it much more difficult and much more expensive for supplement developers to make and market new dietary supplements. Again, there was an outcry and the FDA eventually agreed to make some revisions.

Considering the promised revisions took five years, you would think the new guidelines released just a few weeks ago would be nothing less than earth-shattering. While a few of the revisions appear to be supportive and aimed at easing a little of the burden heaped upon supplement manufacturers, this cannot distract from the major problems that still remain – ones that are drastic enough to cause irreversible damage to the supplement industry. In other words, the small positive changes are not nearly enough to outweigh the bad. The main stipulations imposed by the FDA’s guidelines will drastically affect new dietary supplements getting into the hands of consumers and could very likely devastate the industry as a whole.

Some of these include:

• The requirement for more extensive safety studies than are required for pharmaceuticals (costing millions per ingredient)
• Vague/confusing wording which will inevitably lead to misinterpretation and wrongful enforcement by the FDA
• The requirement of additional safety studies if the target population changes (again, not required for drugs)
• The decision that synthetic botanical ingredients are not considered dietary ingredients unless it is one that is already present in the food supply (this was actually an improvement from the 2011 version)
• The rule that once a drug company submits an IND (Investigational New Drug document) for a pharmacological agent, supplement companies cannot submit a NDI (new dietary ingredient document) for the same substance
• An expanded list of which substances require a NDI to be submitted

In a nutshell, these requirements seek to “fix” an industry that’s not broken to begin with, all the while shifting the FDA’s focus away from the industry where the dangers are much greater. If no one intervenes and holds the agency accountable for overstepping its limits and directly going against Congress, the end result will be skyrocketing supplement costs, the loss of roughly 55,000 to 100,000 jobs, and drastically reduced access to current and any future dietary supplements. Ironically, this comes at a time when industry compliance, empirical data on the positive effects of natural pharmacologic agents on health, and technological advancements to improve manufacturing and quality of dietary supplements is at an all-time high.

This blow to the supplement industry also gives pharmaceutical companies the chance to use their money and power to essentially step in, molecularly alter a natural substance enough to market it as a drug (because remember, natural substances can’t be patented), and prevent that substance from ever appearing in a dietary supplement again. The ramifications of all this could be downright disastrous for the consumer. If you want to learn more about these changes and how you can take immediate action against these guidelines, visit:

FDA: Massive Attack on Supplements 要么 Supplement-Killing Guidance Just Issued by the FDA Must Be Opposed

Let’s take the future of dietary supplements out of the hands of those with profit motives and place it into the hands of those who truly value health freedom and access to safe and effective dietary supplements.

References

1. FDA: Massive Attack on Supplements. Alliance for Natural Health website. Aug 15, 2016. Available
2. at: http://www.anh-usa.org/fda- massive-attack- on-supplements/
3. Light, D. “New Prescription Drugs: A Major Health Risk With Few Offsetting Advantages.” Jan 16, 2015. Available at: http://ethics.harvard.edu/blog/new-prescription- drugs-major- health-risk- few-offsetting- advantages
4. O’Conner, A. Dietary Supplements Lead to 20,000 ER Visits Yearly, Study Finds.” Oct 14, 2015. Available at: http://well.blogs.nytimes.com/2015/10/14/dietary-supplements- lead-to- 20000-e- r-visits- yearly-study- finds/
5. Saul, A. “No Deaths from ANY Dietary Supplement. Orthomolecular.org. Jan 16, 2015. Available at: http://orthomolecular.org/resources/omns/v11n02.shtml
6. Tips, S. “Supplement-Killing Guidance Just Issued by the FDA Must Be Opposed.” GeenMedinfo. Aug 16, 2016. Available at: http://www.greenmedinfo.com/blog/supplement-killing- guidance-just- issued-fda- must-be- opposed