Last year, we told you about the FDA’s massive attack on supplements that came in the form of a guidance document. That guidance is meant to provide clarity to supplement companies regarding “new supplements”—referred to as new dietary ingredients, or NDIs. The FDA’s proposed NDI notification process remains one of the largest threats to the supplement industry ever.
Vinpocetine, a natural nootropic (nōəˈträpik), is an active ingredient in several brain boosting supplement formulas. It is also sold as an inexpensive supplement by itself. Nootropics are neurologically active memory and cognitive enhancers, promoting well being and learning potential. It is the sole ingredient of an Eastern European medicine, used since 1978 for recovering stroke victims and other neurological issues called Cavinton. Its use has spread throughout Asia and other parts of Europe. Both Cavinton and Vinpocetine, extracted from the periwinkle plant, have been tested, studied, and tried internationally for several neurological issues with mostly highly positive results since 1978. Along the way, other benefits were discovered related to heart health, vision, hearing, and more. Now there is a current controversy involving the FDA and a Missouri Senator seeking to restrict public access to this supplement which has a long history of use outside the U.S.
Are Supplements Killing Children? No – Children More likely to Die from Swallowing Batteries than Vitamins
Last week, a paper in the Journal of Medical Toxicology reported that calls to poison control centers concerning dietary supplements were up 50% over the period 2005-2012, with most of those calls relating to small children. The mainstream media pounced, questioning whether parents should risk storing supplements at home. As with previous attacks against supplements, however, an analysis of the underlying data shows that supplements are overwhelmingly safe products. Nearly 90% of all consumer calls to America’s poison control centers are about drugs and other man-made chemicals. Children are far more likely to die from swallowing batteries than vitamins. Children are far more likely to die from swallowing batteries than vitamins. In 2015 alone, 42 children under the age of 5 died after ingesting analgesics, batteries, air fresheners and other chemical products – whereas not a single child died from accidentally swallowing vitamins or dietary supplements. In 2015, a similar media outcry ignited when the US Department of Health and Human Services asserted that supplements send 23,000 people a year to hospital emergency rooms. On closer inspection, though, ANH found that 20% of the cases were the result of unsupervised children swallowing pills, and 40% involved adults over the age of 65 who choked on their pills. In other incidents, heart palpitations resulted from ingesting too many diet pills, taking sexual enhancement pills, and/or downing energy drinks. The current brouhaha is likewise slanting and “cherry picking” the data. It’s probably no coincidence that the recent outcry is citing data from 2005-2012, when consumers’ use of dietary supplements vastly increased. Greater consumer use of any product is bound to produce more consumer questions and concerns, whether or not any actual cases of poisoning result. While FDA-approved drugs kill hundreds of thousands of patients a year – even when properly prescribed – the mainstream media doesn’t bat an eye. Supplements have killed zero people, yet there is a consistent media drumbeat for more regulation and government oversight over dietary supplements. What is never mentioned is that supplements are already regulated, and that treating them like drugs will raise their prices to drug like levels, or more likely eliminate them entirely from stores because producers cannot afford to spend so much on non-patentable products.
According to the most recent data, there are zero deaths from supplements. But the FDA’s tightening of supplement regulations is for our safety, right? Action Alert! Every year, the American Association of Poison Control Center’s National Poison Data System (NPDS) releases an annual report that tracks deaths and serious adverse events as a result of poisoning from a wide variety of substances, including drugs and supplements. NPDS is “the only comprehensive, near real-time, poisoning surveillance database in the United States.” According to the most recent report, ZERO Americans died from taking any supplement in 2013. That includes anything from substances that must be taken with care and medical guidance, such as kava kava or yohimbe, or ayurvedic medicines (which must be sourced with care to be sure they are free of heavy metals), to standard vitamins and amino acids, to the gentlest homeopathic remedies. Of course, to most of us in the natural health world this is unsurprising. Dietary supplements have an exemplary track record of safety. In fact, our partners at ANH International calculated that, according to the European Union’s own data, we are more likely to be struck and killed by lightning than die from taking a supplement.
The long-awaited revision of FDA guidance rules for new supplements is finally here. It is very bad news. Highest-level Action Alert! What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements. The FDA, working as usual on behalf of the drug industry, says no. We need your help to stop this right now. It will take a huge effort on all of our parts and we need to start immediately.
More supplements face the axe at the next meeting of the FDA’s Pharmacy Compounding Advisory Committee. If recent history is any indication, the outlook is not good—unless we push back.
A PBS Frontline documentary argues that supplements are useless—relying on “expert testimony” from paid Pharma representatives. Last week, PBS’s Frontline aired an hour-long program titled “Supplements and Safety.” Jointly produced by Frontline, the New York Times, and the Canadian Broadcasting Commission, the program was clearly intended to leave viewers with the one-sided impression that dietary supplements are unregulated, unsafe—and that ultimately you, the consumer, should not have the right to stay healthy in a manner of your choosing.
The mainstream media is using a new study funded by the US Department of Health and Human Services (HHS), released last week, to renew the false charges that supplements are unregulated, unsafe, and require more federal oversight. Even a cursory examination of the data provided in the study, however, demonstrates once again that the alarmist headlines and the calls for tighter regulations are completely unsupported by the evidence.
A new study has been published by a psychiatrist working for a VA hospital educating other psychiatrists on how to protect their patients against the dangerous side effects from coconut oil and other natural supplements. However, with no recorded deaths due to the side effects of coconut oil or other natural supplements in recent years, and with the medical community themselves admitting that over 100,000 people a year die from their prescription drugs, one has to wonder who is really being "protected" with this advice?
You can’t live without this vitamin. But the FDA wants to reserve the natural form for monopoly drug companies, leaving only the synthetic form for supplements. The FDA has just released a new 109-page guidance on the revision of nutrition and supplement labels. On page 69, the agency slipped in two little paragraphs that could risk the health of millions of people who desperately need folate. It’s a sneak attack so quiet and unobtrusive that few people will even realize it’s there.