You know, over the past few years I’ve very peripherally heard about some drug/supplement called “ephedrine”. I heard that it was banned from sale in the USA, and didn’t give it much thought. After all, I could still run down to the local pharmacy and pick up Sudafed, which was my one-stop-drug whenever I had a runny nose, and had been for years. It contained pseudophedrine — thus the name — and worked fine. If I were having trouble sleeping due to breathing congestion, I’d pick up NyQuil, which IMHO is the best night-time cold remedy on the planet and has been for decades. No biggie, right?
Then one day a few months ago, I tried to buy my tried-and-true remedy for nasty colds, and found that I couldn’t find one that worked. The old Sudafed formulation had been replaced with a new one that, well, was about as effective as not taking anything at all. Also, the same NyQuil I’d always taken had been removed from the shelf, renamed NyQuil-D if I wanted the same ingredients, and hidden behind the pharmacy counter.
There was a little card instead of a product, telling me to go to the pharmacy counter if I wanted to buy the product.
WTF?
I didn’t buy anything that day because the pharmacy was closed, and suffered through using some of the remedies in our cabinet, including the crippled Sudafed. Unfortunately, most of the medications in our cabinet stink at actually alleviating cold symptoms for me.
On the plus side, I cleared out several dozen expired medications from the cabinet in the search for something that would work well for my runny nose that day.
Ephedrine and pseudophedrine-based medications are where it’s at for alleviating cold symptoms. They simply do a better job quicker than anything else for me. The “secret sauce” has been removed — or renamed to indicate the old formulation is now a behind-the-counter-only remedy — and I wanted to get to the bottom of the mystery.
So, of course, I turned to the Internet for research (note I don’t use the phrase “the facts”). Let me tell you, if you google “ephedrine ban”, you’re going to come up with several thousand pages with various explanations of what happened. From ephedrine loyalists to Chinese Herb practitioners to the FDA defending its ruling to the court cases that eventually upheld the ban, there are a thousand stories.
Here are the basic facts, as far as I can glean them. Note that this story has two parts to explain why ephedrine is harder to come by today than it used to be. I’m not going to delve into the pharmaceutical-company conspiracy theories; you can read plenty of those yourself in the front-page links on a Google search for the topic.
Ephedra is an herb that contains very small amounts of ephedrine, a highly potent bronchial dilator with powerful metabolism-boosting side effects. Ephedrine can be refined from naturally-occurring sources or synthesized in the lab. It gained popularity in the nineties as a weight-loss supplement because, combined with caffeine and a calorie-restricted diet, it both boosted the basal metabolic rate of study subjects as well as dramatically diminished appetite. At one point, it was estimated that approximately 10% of the American adult population — some 20+ million people — were taking ephedra or ephedrine-based supplements, mostly to aid in weight loss.
The FDA began investigating ephedra (the un-refined version of ephedrine) almost immediately after the passage of the dietary supplement act in 1992. Ephedra’s effects were quite drug-like, and in fact refined and synthetic ephedrine had been an ingredient in cold remedies and asthma medications for decades. However, as a dietary supplement under the Act, the burden of proof was on the FDA to prove an ingredient was not safe.
Eventually, the FDA’s research concluded that ephedra is deadly in sufficient quantities, implicated in a higher incidence of brain hemorrhage (at 32 mg/day or more) in otherwise healthy people, and that no dose is safe for people on antideppresants, MAOI (antidepressant) drugs, or with a heart condition or diabetes.
Type 2 diabetics represented a large proportion of the people taking ephedra because type 2 diabetes is associated with obesity, and the obese have the greatest interest in weight-loss. Unfortunately, Type 2 diabetics and the obese also are the most likely to have heart disease, high blood pressure, thyroid disease, and be on antidepressants.
The FDA passed a rule intending to ban the substance in 1998, and in 2002 the rule took effect. By 2004, they issued a final ruling and were prosecuting companies that did not comply with the rule against putting ephedra/ephedrine in herbal supplements that did not require labeling like over-the-counter drugs did. The ruling was challenged and in 2006, and eventually the FDA’s decision was upheld. Ephedra is now regarded as a drug, and now the burden-of-proof is on manufacturers to demonstrate the safeness of their product before putting it on the shelf with the “drug facts” labels, active ingredients, and all the usual disclaimers.
There were some exceptions to the ruling: traditional Chinese herbal remedies and herbal teas which were both regulated as “foods” rather than “supplements”. So the Chinese herbalists can be assuaged — though I expect this loophole to be abused — and those who like teas with ephedrine in them are unaffected.
Now here comes punch #2 in the one-two punch: the Combat Methamphetamine Epidemic Act of 2005. Really, the FDA ban on ephedrine in herbal supplements never affected me in the least. However, Congress’ act to try to reduce meth production really did. Basically, this act enforces the following provisions related to ephedrine:
- Minors may not purchase.
- You may purchase no more than 7.5g every 30 days via mail-order. Note that this is a bigger issue for pseudophedrine than ephedrine, because the dosage is typically 3-4 times higher for the same effect.
- You may not purchase more than 9g per month total.
- All purchases must be logged, and all products containing ephedrine or pseudophedrine must be kept in a locked or secure location to enforce logging of purchases.
- All purchases must be logged, and you must provide a valid ID to purchase.
- Products must be sold in individual-dose blister packs. I guess this makes it less convenient than just dumping a whole bottle in for the meth manufacturers.
So basically, it turns out ephedrine and pseudophedrine are both still perfectly legal for personal use, if a bit irritating, time-consuming, and risky to purchase if buying for an entire family. However, if you buy over-the-counter allergy, sinus, or asthma medications for your children, you might be charged with a misdemeanor for going over the magical 7.5/9g limits.
For perspective, 9g/month is around two to three times the dose any adult should be expected to reasonably take, even if that adult is taking the usual 60mg/day dosage that people recommend in the ECA (ephedrine/caffeine/aspirin) stack for weight loss. The only downside for those using ephedrine for weight-loss is that now you have to buy your ephedrine in the form of asthma, allergy, or cold medication. And I think it’s important to keep in mind that most of the clinical trials of ephedrine for weight loss used 25mg/day or less in the subjects, and that anything over 32mg/day has been implicated in strokes in otherwise healthy subjects.
I’m going to give a home-made ECA stack a try, since I’ve really nailed the diet and exercise program and am losing a reliable 1-2 pounds per week. I’ll provide a report as to the effectiveness at some point in the future.
But hey, at least I know how to get my “real” Sudafed and NyQuil now. And I’m no longer scared of taking that little placard up to the pharmacy counter. I’m not making methamphetamines, I’m not buying an herbal supplement, and I’m not buying enough to cover multiple children with asthma or colds. One signature and a very scary-sounding stern warning about not falsifying my identity later, and I walk out with an actual effective cold & allergy remedy instead of the ineffective almost-a-placebo crap that is now sitting on the store’s public shelves.