fda

Earlier this week, on April 16, 2019, the FDA issued warning letters to 3 companies have products that are marketed as dietary supplements with a label saying they contain Phenibut. These companies have been told to stop distribution of the current products and to let the FDA know within 15 days what they plan to do to be compliant with the law.

Quite frankly, I’m surprised it’s taken this long, and I actually agree with the decision. However, there are some major problems that are being overlooked with a decision like this, such as the dire consequences for susceptible individuals currently tapering from Phenibut or needing to do a slow taper once they no longer have access to Phenibut (more on that below).

The good news is that GABA, when used correctly i.e. used sublingually as part of a trial process to find the ideal amount for each person, is as effective and with none of the dependence and withdrawal issues.

Here is the announcement on the FDA site:

Phenibut has been found in products labeled as dietary supplements, sometimes marketed for uses such as a sleep aid. Phenibut does not meet the definition of a dietary ingredient Under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Products labeled as dietary supplements that list phenibut as a dietary ingredient are misbranded.

Phenibut is also known as:

• fenibut
• phenigam
• PhGaba
• Phenigamma
• Phenygam
• 4-Amino-3-phenylbutanoic acid
• β-(aminomethyl)benzenepropanoic acid
• beta-(Aminomethyl)hydrocinnamic acid
• β-phenyl-γ-aminobutyric acid

The companies have 15 business days from the date of receipt of the letter to communicate to the agency the specific steps they will take to bring their products into compliance with the law. The warning letters also caution the companies that the FDA may take enforcement action without further notice if they do not immediately cease distribution of the products.

A reaffirmed commitment to traditional advisory and enforcement actions, such as warning letters, in combination with the newly launched rapid-response tool, the Dietary Supplement Ingredient Advisory List, are integral parts of the FDA’s overall effort to strengthen the agency’s regulation and oversight of dietary supplements. We continue to look for ways to modernize our approach to protecting consumers from misbranded, unsafe, or otherwise unlawful dietary supplements.

I have always been very open with my warnings and have never recommended Phenibut because of the dependence issues and the fact that withdrawal can be similar to benzodiazepines. I blogged about my concerns back in 2016: Why I recommend GABA for anxiety instead of Phenibut

Here are a few highlights from this blog:

• I have concerns with Phenibut and I don’t feel anyone should be using it
• It is widely used in Russia as a prescription medication for anxiety, tension, fear, to improve sleep, pre- or post-operatively, depression, post-traumatic stress, stuttering and vestibular disorders
• It’s available over-the-counter and as a supplement in the USA and the UK. It’s no longer available in Australia as a supplement
• It’s very effective for anxiety and insomnia and this is why anxious individuals really love it and many practitioners recommend it before they start to see problems
• One of the reasons Phenibut seems to work so well is because it is so similar to benzodiazepines.
• The adverse effects can be similar to those experienced with benzos. This case study is one of many that report physical dependence can develop, including tolerance and withdrawal

Here are a few more recent case studies, reviews and papers on Phenibut:

• Phenibut exposures and clinical effects reported to a regional poison center (the numbers are small: “56 exposure calls over 19 years with 48 (85.7%) calls within the past five years” but we know not everyone feels the need to call poison control)
• Phenibut (β-Phenyl-γ-Aminobutyric Acid): an Easily Obtainable “Dietary Supplement” With Propensities for Physical Dependence and Addiction

Over the last several years, multiple case reports have highlighted phenibut’s potential to produce the conditions of physical dependence, withdrawal, and addiction. In cases involving intoxication, patients have presented with a varying degree of mental status changes, from being minimally responsive to manifesting symptoms of an agitated delirium. Phenibut is a potent psychoactive substance with GABA_B agonist properties, which is emerging as a drug of misuse through growing internet sales. Its marketing as a “dietary supplement” is inaccurate and misleading, given its pharmacological profile and ability to induce the physiological changes associated with withdrawal and physical dependence

• Acute phenibut withdrawal: A comprehensive literature review and illustrative case report . In many of the published cases “Patients were typically younger and had coexisting substance abuse disorders to other drugs” but based on feedback I’ve had from folks in my community and elsewhere this is certainly not the case across the board. However it may be that prior benzodiazepine or fluoroquinolone use may play a role in individuals being more susceptible to issues.
• Phenibut (β-Phenyl-γ-Aminobutyric Acid) Psychosis. This case study was a situation of recreational abuse but even so it shows how severe symptoms can be.

I see no reason to use a product like Phenibut given the potential to cause harm and because GABA (when used correctly i.e. used sublingually as part of a trial process to find the ideal amount for each person) is as effective and with none of the dependence and withdrawal issues.

Phenibut: initially very promising results and then rebound anxiety, panic and insomnia

I’d like to share a story from someone in my community who posted on the 2016 blog above. He shared this about the addictive aspects he observed when he used a Phenibut product called GABA Wave, saying his initial reaction was very positive and quite extreme compared to his previous trials of GABA:

The initial response in the first couple of weeks was great, especially a couple of hours after taking it. The effects were a marked elevation in mood to the point of euphoria, enhanced appreciation for music, improved focus and cognition initially (but that became memory difficulty), marked relief of anxiety, increased motivation, renewed interest in things, being more talkative, a significant calming/relaxation effect, generally a deep and great night’s sleep the night of the morning it is taken.

He then shares how this changed after a few weeks with rebound insomnia, panic and anxiety, and other adverse symptoms:

However, after a few weeks it was the reaction on the following day of taking it that kicked me in the butt, literally. On the following day I began to feel very low, groggy and spaced out, almost like a hangover and then during the following night I began having brutal insomnia – a complete turn-around from the night before. A kind of rebound response. I imagine that’s when the tolerance and addiction begins to develop because one craves the next dose to provide the good night’s sleep after the bad sleep on the second night. Other side effects included mood swings, irritability, rebound anxiety, panic, loss of short-term memory, total and utter loss of any form of libido and constipation!

He shared that his diet and self-care are excellent, but he is dealing with and working past emotional and psychological traumas – and this may make him more susceptible to the adverse effects.

And this is one of the problems with Phenibut – you’ll hear excellent initial reports and for some people this continues. Not everyone is adversely affected but you just don’t know in advance if you will be someone who is adversely affected or just how badly you’ll be affected.

Merry has had very severe ongoing adverse effects from Phenibut.

Merry Citoli shares her warnings about benzodiazepine, lunesta and Phenibut withdrawal

Merry Citoli shares her warnings about benzodiazepine, lunesta and Phenibut withdrawal. Lunesta and then Phenibut were recommended to help her taper from the benzodiazepine she was prescribed for perimenopausal anxiety. At the time of this recording, she had tapered off the benzo and lunesta, but was having great difficulties tapering off Phenibut – almost as bad as her benzo taper.

You can learn more about Merry on Follow Your Bliss. She shares how cathartic it is to share her story and the desire to help stop others going through what she has been through. I’d like to acknowledge Merry for doing this (and all of you for sharing your stories and posting encouraging messages here on the blog for each other).

I’d also like to give a shout out to the Benzodiazepine Information Coalition who is doing amazing advocacy and educational work about these awful medications.

The comments in my 2016 blog: Why I recommend GABA for anxiety instead of Phenibut are worth a read if this affects you. You’ll see there are some very different thoughts on Phenibut safety and folks saying GABA won’t work. This is typical of what you can expect to hear elsewhere online.

I don’t have all the answers

I know many Phenibut users are going to be very concerned about this and we’ll be dealing with many withdrawal issues and folks looking for an alternative. I recognize that this is not going to be easy if there is no Phenibut available for tapering. There are also very serious concerns for those who can’t go cold-turkey off Phenibut and won’t have the time to taper. Abrupt discontinuation of Phenibut may result in withdrawal which can be severe and require hospitalization.

What I don’t know:

• if other companies and products will be targeted too?
• if Phenibut will be made available as prescription in some form or another?
• what resources are in place or going to be put in place for individuals who are in the process for trying to taper from Phenibut right now (or if there is even the awareness that this is an issue and very needed? For people like Merry, cold-turkeying off Phenibut could be life-threatening)
• what advocacy groups and benzo support groups know and what advice do they have?
• what my colleagues know and are planning to do?
• why so many practitioners recommended it and why so many companies made it available as a supplement, given the research/case studies and the issues so many individuals report?
• if there will be a place to submit concerns and complaints?

What I do know – GABA and the foundations

Give GABA serious consideration for safe and comfortable tapering (assuming there is enough Phenibut to do slow tapers) and for ongoing support of the low GABA symptoms of physical anxiety and tension.

It’s really best that you work with your practitioner. As with a benzodiazepine, before starting a Phenibut taper, I’ve always found it’s best to get nutritionally stable as possible first and address all root causes of anxiety before starting to taper and then tapering Phenibut very very very slowly. For some folks it’s just very uncomfortable for a few weeks and for others it’s a long-term ordeal.

I use GABA sublingually after an initial trial to find the ideal amount for each person. I have found that for both a benzo and Phenibut taper, very very tiny amounts (like a pinch or dab) will be enough for some folks.

Other nutrients are used based on each person’s need – such as theanine, tryptophan, melatonin, niacinamide, zinc and vitamin B6 and others. Light therapy, exercise, yoga, meditation, getting out in nature and essential oils like lavender, citrus and jasmine are also wonderful to incorporate. Of course, diet, blood sugar control and gut health are the foundation.

These are various GABA products I use. You can find some examples on my supplements blog here:

• Source Naturals GABA Calm (with additional information here)
• Nutritional Fundamentals for Health GABA-T SAP: gamma-aminobutyric acid (GABA) 300 mg, l-theanine 150 mg. This is pleasant-tasting when opened on to the tongue and works very well when GABA Calm can’t be used.  I find best results when it is used opened on to the tongue.
• Enzymatic Therapy GABA: gamma-aminobutyric acid (GABA) 250 mg. This is also pleasant-tasting when opened on to the tongue and works very well when GABA Calm can’t be used.  As with all GABA products, I find best results when it is used opened on to the tongue.
• ProThera 500mg GABA: gamma-aminobutyric acid (GABA) 500 mg.  You will likely need to open this up and start with less than a full capsule during the day. A full capsule may be fine at night for some individuals.

They can all be purchased from my online store here.

As you can see, I don’t have all the answers about this FDA announcement, but I wanted to share what I do know so you are aware of what’s going on.

In the next few weeks I’m going to be reaching out to benzodiazepine groups, colleagues, the companies affected and individuals who are in the process for trying to taper from Phenibut. As I learn more, I’ll share what I learn.

In the meantime, please post questions you may have, and I’ll do my best to either answer them now or find answers for you.

And please do share your Phenibut stories (both good and bad), your concerns, and any resources you may have.

And do share if GABA has help you taper from Phenibut.