I found the manufacturer's response on another forum -
Q: Phenibut can quickly lead to significant withdrawals after short term use. Have you done enough to warn the consumer of this danger?A:
Quote: Open1 does have clear warnings that it must not be consumed above specific daily and weekly intake levels. Open1 also clearly indicates that it contains calming amino acids that may cause drowsiness and that caution should be used when operating a motor vehicle. Open1 also clearly indicates that it should not be combined with
alcohol or sedatives. It is clear from the warning statement that Open1 is a highly functional and effective product, and that it must not be consumed to excess.
If a consumer is willing to exceed 240 mg of
caffeine per day and 240 mg of 5-HTP per day, the consumer may achieve levels of
Phenibut consumption which could potentially cause this issue to become relevant. However, the question I would ask you is as follows: If the consumer does not read the existing label warnings or follow the use directions on the can, why would adding additional warnings on our packaging change this? Also, should we also include warnings that exceeding 240 mg of caffeine per day can also lead to caffeine tolerance and
withdrawal?
We currently feel that clear, unambiguous daily and weekly intake guidance on our label is sufficient warning to the consumer, given the level of Phenibut in Open1, and given the level of Phenibut in proportion to the other, highly active ingredients. However, we are open to feedback on this point. If our customer base tells us that stronger and more prominent warnings are in order, or that they do not feel a Phenibut containing tonic is unacceptable at any Phenibut level, we will update our packaging or reformulate accordingly.
Q: Even if addiction/withdrawal is not yet documented in scientific documentation at this time, I and countless others can confirm that this is very real. Why is there no warning on the can or packaging to explain this danger to the consumer? A:
Quote: The simple answer is that the level of Phenibut in Open1 is too low, at the directed use levels, to approach the levels that have been discussed as leading to problems with Phenibut addiction and withdrawal. It would require exceeding the label directions, and consuming large amounts of other active ingredients with self-limiting properties (overstimulation from caffeine, nausea from 5-HTP, etc), in order to consume the amounts of Phenibut that have caused reports of addiction and withdrawal.
As mentioned earlier, we currently feel that clear, unambiguous daily and weekly intake guidance on our label is sufficient warning to the consumer, given the level of Phenibut in Open1, and given the level of Phenibut in proportion to the other, highly active ingredients. However, we are open to feedback on this point. If our customer base tells us that stronger and more prominent warnings are in order, or that they do not feel a Phenibut containing tonic is unacceptable at any Phenibut level, we will update our packaging or reformulate accordingly.
Q: Why is phenibut not listed as an ingredient on your amazon(dot)com listing or Open1 facebook? A:
Quote: Phenibut is shown on the Amazon.com listing in the large photo of the product. It is listed on both the can supplement facts, and prominently called out on the top panel of the 4-Pack cartons. It is a valid suggestion to update the Amazon product description text to individually list the components of the Celevate blend.
We do not have an ingredient listing on Open1's Facebook page, because there is a low character limit on the page summary. Several posts on our Facebook page show large, high resolution photos of the cans and 4-pack cartons, each of which clearly shows the ingredients. It is a valid suggestion to make a series of Facebook posts going through each of the individual ingredients in the product, discussing what they are, what they do, what risks they might pose, and links to research.
Q: Phenibut would be the main active in the product, unless the content is extremely miniscule. A:
Quote: This is not correct. There are seven ingredients in the nutraceutical blend in Open1. Each one is present in substantial and effective amounts, that, on their own, would be quite noticeable even if the Phenibut was not present. I will not list the amounts of each ingredient, but possibly with the exception of Inositol, you would definitely be aware of taking the quantity of each one on its own, whether it is the caffeine, the 5-HTP, the GABA, the hordenine, or the L-
Theanine. Removing Phenibut would make it a less helpful product, but absolutely would not render it an ineffective or inactive one.
Q: The reason I bring this up is there are a lot of people who don't want to see FDA action against phenibut or your product. A:
Quote: The FDA would have two reasons to take action against Phenibut or Open1.
The first reason is if they determine that Phenibut is not a valid dietary ingredient. The statue defines a dietary ingredient:
'A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites, extracts or concentrates of any of the above.' Phenibut is structurally defined as an amino acid, and thus meets the definition of a dietary ingredient.
The second reason is if they determine that Phenibut is not a safe ingredient.
Open1 does not contain enough Phenibut, compared to the other ingredients, and in light of the cost per Phenibut content, to come close to posing the same risk as is raised simply by making Phenibut available in pure form, as is currently done by most Phenibut sources. Open comes with clear use instructions and warnings that direct the consumer to avoid consumption levels, combination with other substances, or activities which could lead to a determination by the FDA that Phenibut is not a safe ingredient. It is not practical to consume more than 1200 mg of Phenibut by consuming Open1, without being overstimulated by caffeine, nauseated by 5-HTP, and limited by the 15x higher cost of buying Open1 compared to just getting pure Phenibut.
Q: I am in no way bashing your product, I am just worried that people may not fully know of the nature of phenibut before they consume the beverage. Which could lead to Issues.Quote:
Open1 is currently, and for the foreseeable future, distributed in very limited amounts to a very limited number of stores. There is no advertising or marketing for Open1. Unlike many widely marketed products such as energy drinks and relaxation drinks, Open1's packaging and positioning steers it clearly away from under 18's, being perceived as a substitute for legally restricted substances, or "extreme" users. It is designed to avoid controversy or sensationalism which could trigger FDA attention, and the approach to putting the product on the market will keep this as a foremost priority.
As we get continued feedback from our consumer base, we remain open to updating the product to add more prominent warnings, calling out Phenibut in more places, reducing the can size, and reformulating to further reduce (or even eliminate) Phenibut content.
At this point we do not feel all of these steps are necessary, but we will keep an open mind, be informed by the community discussion on this issue, and remain mindful that Phenibut is a truly helpful supplement for lots of folks, to which many concerned people wish to preserve access
Sincerely,
Mark, Open1
This all sounds reasonable enough - but everyone knows that lots of people totally disregard the warnings on energy drinks. I've worked with a lot of idiots at overnight jobs who literally drink three Monster energy drinks a night that each contain two servings.
Putting phenibut in beverage form just encourages people to use it every day as part of their usual routine, in the same way that people use energy drinks. Once someone drinks a couple cans of Open1 every day for a few months and then develops crippling insomnia when they stop, that's all it's going to take to get significant FDA attention.
I'm liberal, but I really hate this nanny state b.s. when it comes to drugs. It's definitely unethical to put a psychiatric drug in an "all natural" energy drink, but the main issue is that the average person is going to just consume this stuff with absolutely NO research and then they'll scream for phenibut to be banned after they develop health problems.
Edited by moleface, 31 December 2012 - 05:05 PM.
