A buried provision in Congress’ latest supplement broadside gives the FDA everything it wants to take away the supplements you rely on. Action Alert!
Last week, we updated you on the current threats to your supplement access. We’re facing a multi-headed snake: Sen. Dick Durbin (D-IL) has his stand-alone supplement registration bill, and separately, a similar policy has been added to the Senate version of the Prescription Drug User Fee Act (PDUFA) reauthorization. But it gets worse. Hidden deep in this 400-page PDUFA bill is a provision that is a dagger to the heart of your supplement access. We need a powerful, sustained grassroots response to stop both of these bills from moving forward.
The buried provision in PDUFA that we’re referring to prohibits “the introduction…into interstate commerce of any product marketed as a dietary supplement that does not meet the definition of a dietary supplement…” The agency says this clarification of the law is necessary so it can take action against supplements spiked with drugs. Like Sen. Durbin’s bill, this sounds reasonable, but this language allows the FDA to eliminate supplements you care about that compete with drugs.
CBD is a perfect example. The FDA has said that this incredible plant compound doesn’t meet the definition of a supplement because CBD has been approved as a drug that costs $32,500 a year. If the above-mentioned provision was in place, the FDA could have immediately swooped in and put a stop to CBD sales for good.
This would be a tragedy. CBD has many health benefits that we’re learning more about every day. It has applications for pain, anxiety, depression, sleep disorders, substance abuse, and even infections. If the FDA could easily remove CBD supplements from the market, many patients would lose access to a supplement that helps them. The alternatives are often very dangerous. We’re all aware of the national catastrophe that is the opioid epidemic, and the global catastrophe that is antibiotic resistance. But the FDA doesn’t care about that, as long as the bottom line of the drug company with the CBD monopoly is protected.
CBD isn’t the only supplement threatened by this policy. Other supplements that have been turned into drugs by the FDA back channel, such as l-glutamine, are also threatened. Pyridoxamine, a natural form of vitamin B6, has already been eliminated. The FDA has said that resveratrol, a plant-derived polyphenol found in grapes, also doesn’t meet the legal definition of a supplement because a drug company started investigating it as a drug in 2001, and the agency has no evidence that resveratrol was sold as a supplement before that date.
And those are just the ones we know about. In 2016, the FDA announced that vinpocetine, a derivative of the lesser periwinkle plant, wasn’t a supplement because a drug company was investigating it as a drug…in 1981. Untold numbers of supplements could be threatened by this secretive process, because investigational new drug applications—the forms filed when a drug company starts researching a compound for use in a drug—are not publicly available, so it’s hard to know exactly what supplements are threatened.
Again, consider what we’re losing if this policy gets enacted:
- L-glutamine helps maintain muscle, boosts the immune system, supports gastrointestinal health, and helps to maintain healthy growth hormone levels. Every cell in the body uses glutamine–it is an essential amino acid that the body cannot function without. Glutamine is food; for a pharmaceutical company to claim glutamine as a drug is similar to claiming walnuts or blueberries as drugs, and insisting they can no longer be sold as foods.
- Resveratrol has many health benefits— it is an antioxidant, anti-inflammatory, neuroprotective, may reverse arterial aging, anti-cancer, to name just a few of its life-extending benefits.
- Vinpocetine has a number of uses, including neuroprotective effects; it improves brain health and cognitive function, and has virtually no side effects. Dr. Russell Blaylock, in the February 2016 issue of his Blaylock Wellness Report, notes that other positive effects of vinpocetine include reducing cellular calcium (too much calcium in cells is very toxic), improving blood flow, reducing excitotoxicity, protecting mitochondria, reducing inflammation, reducing fat peroxidation, and exhibiting anti-cancer potential.
As we said previously, Sen. Durbin’s bill accelerates a sharp reduction in consumer choice in supplements, undermining our ability to stay healthy, naturally. We must keep up the pressure so this policy does not become law and our supplement choices disappear.
Action Alert! Write to Congress and tell them to oppose mandatory product listing for dietary supplements. Please send your message immediately.