Dynamine Achieves GRAS Status With Several New Safety Studies!

Compound Solutions

Major news is here from Compound Solutions…

In early 2018, we wrote the first major article about Dynamine™, the patented neuro-activating “stimulant” sold by Compound Solutions. More technically referred to as Methylliberine, the ingredient has since been put into countless pre workout supplements, fat burners, nootropics, and energy formulas, and we’ve found that we love really enjoy it at higher doses (around 100mg) when paired with caffeine.

Dynamine™ is similar to Theacrine, but takes effect more quickly, which made it popular for pre workout supplement formulators looking for a little something ‘extra’.

Things are now looking even better for safety-oriented brands, stores, and consumers alike:

Dynamine has achieved GRAS status, as in Generally Recognized as Safe!

Dynamine GRAS

Dynamine is Now GRAS! Prepare for Improved Energy Drinks, Gaming Supplements, Nootropics, and far more!

Dynamine™ is GRAS!

Around July 3, 2019, after years of research and three new safety studies, the FDA sent their Letter of No Objection (LONO) to Compound Solutions, in response to their rigorous, in-depth GRAS application. Per a panel of industry experts, scientists, and PhDs, Dynamine is now generally recognized as safe!

The GRAS dose is 105mg, as determined from the 90-day seminal toxicity study. This means that it must be safe at 100x that effective dose. That’s great news because Compound Solutions used 100mg as the clinical dose in their studies, and it’s also our preferred dosage for improved energy and mood!

We discuss the safety studies in more detail below, but first, it’s best to hear it from the CEO of Compound Solutions himself, Matt Titlow:

Matt Titlow, CEO of Compound Solutions, discusses the Dynamine™ News with PricePlow:

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Download Compound Solutions’ Dynamine GRAS Dossier and the 2019 Dynamine Media Kit

(Compound Solutions has additional documents available by request)

Official statement from Compound Solutions

The company’s press statement publishes on Monday, July 8th, and this is a part of that statement:

It’s EXTREMELY rare to find a compound with a sensory experience as good as Dynamine™ with a safety profile so benign. The FDA requires that our dose is safe with a 100x safety factor. That is, it would still be safe if you took 100x the dose. If caffeine were subjected to the same scrutiny, caffeine would be unsafe! Again, Dynamine™ is truly extraordinary and will redefine the energy drink industry.

— Compound Solutions

How Dynamine™ Works

Dynamine

Dynamine (methylliberine) is a caffeine derivative developed by Compound Solutions that’s considered to be a faster-acting theacrine (TeaCrine). We’re huge fans at a 100mg effective dose!

You can read more on our main Dynamine™ page for details, but the quick synopsis is that Dynamine™ and Theacrine both serve as methylurates, a rare class of bioactive ingredients that are neuro-activating yet don’t affect heart rate, blood pressure, or vasoconstriction (pressor response). So they stimulate the CNS, but not the cardiovascular system.

This methylliberine molecule can cross the blood-brain barrier (BBB) faster than Theacrine for faster effects, and providing a smooth-feeling activation of dopamine receptors as well as downstream signaling for other neurotransmitters (norepinephrine, serotonin and GABA).

It’s also hypothesized that it Dynamine gently inhibits adenosine receptors, yielding less tiredness (compared to caffeine, which is more of an adenosine blocker).

Ultimately, you’re left with a strong but smooth mood-enhancing ingredient with many of the euphoric properties we love, without being overwhelming. More importantly, it’s also free of side effects we don’t like from similar ingredients, since it doesn’t alter cardiovascular status.

Dynamine’s Safety Studies

Upon its early 2018 launch, Compound Solutions informed us that they had performed several genotoxicity studies, chromosomal aberration, and mutagenicity studies. Many of these were on animal models, but in order to achieve GRAS status — which was the plan from the start — they would also need human safety research.

Dynamine Safety

Compound Solutions did things right with Dynamine, and that cost a ton of money. Worth it for both brands and consumers? Absolutely.

So in addition to five comprehensive safety studies in animals on Dynamine to achieve GRAS, there are three safety and efficacy studies underway in humans, as well as another studying pharmacokinetics.

That research is now surfacing, and it looks incredibly promising:

  • ISSN Presentation: 4-Week Dynamine Study (with and without Theacrine) on 100 Subjects

    The first study was recently presented at ISSN (International Society of Sports Nutrition), with an abstract provided.[1] 100 college-aged men and women were randomly assigned to the following groups:

    • Low dose Dynamine (100mg)
    • High dose Dynamine (150mg)
    • Low dose Dynamine with TeaCrine (100mg Dynamine + 50mg TeaCrine)
    • High dose Dynamine with TeaCrine (150mg Dynamine + 25mg TeaCrine), and
    • Placebo (125mg Maltodextrin).

    For the first dose, Baseline ECG, RHR, BP and psychometric parameters (energy, feeling of productivity, alertness, desensitization, motivation to do physical tasks, motivation to do mental tasks, and perceived level of focus) were taken, as well as after the dosage every 30 min until 120 min.

    Dynamine Research

    We haven’t seen this amount of research go into a new ingredient — especially a stimulatory one — for quite a long time!

    They were then instructed to take their supplement upon waking up for four consecutive weeks. The visual measurements above were repeated after one and two weeks, while all baseline assessments were repeated after four weeks of supplementation.

    What they determined was downright crazy:

    A supplement safety improver?!

    The study showed that the Dynamine group actually had healthy decreases in heart rate and blood pressure! This means that it’s possible for a formulator to decrease the caffeine content, substitute in Dynamine, and get the same or better response with fewer adverse event reports – a total game-changer!

    We’ve never known a compound with this significant of a sensory experience combined with that kind of safety profile.

  • Upcoming Safety Study 1: Cardiovascular Effects of Dynamine (with and without Theacrine)

    125 subjects were recruited into five different groups (25 per group) to understand the cardiovascular effects (or lack thereof) of Dynamine, both when used alone and when paired with Theacrine.

    The researchers measured:

    Caffeine Theacrine Dynamine

    Both theacrine and dynamine are derived from caffeine, the ‘king’ of all stimulants, and they combine forces to make for an extremely positive experience.

    • resting heart rate, blood pressure, and heart function via electrocardiogram (ECG),
    • clinical blood biomarkers such as lipids, metabolic panel, and white blood cell count, and
    • the self-reported psychometric measures of energy, focus, alertness, feelings of productivity, desensitization, and motivation to complete mental and physical tasks.

    Five dosage groups:

    1. 150 mg placebo
    2. 75mg Dynamine™
    3. 150mg Dynamine™
    4. 125mg TeaCrine® + 75mg Dynamine™
    5. 62.5mg of TeaCrine®+ 150mg of Dynamine™

    The data will be released to the public in August of 2019, but Matt told us in our interview above that it performed as suggested in early 2018.

  • Upcoming Study 2: Marksmanship

    Dynamine Caffeine

    Consider This: If Caffeine were held to the standards that Dynamine was held to here, it would have failed!

    54 subjects were placed into three groups (18 per group) in order to determine and compare the cognitive performance and marksmanship effects of TeaCrine®, Dynamine™, and/or caffeine against a placebo or caffeine condition, after a mentally fatiguing protocol.

    The study was randomized, placebo-controlled, and double-blinded.

    The groups included:

    • 300mg Placebo (P)
    • 300mg Caffeine (C) condition, or
    • 350mg Caffeine + 50mg TeaCrine + 100mg Dynamine (DC) condition.

    Subjects were given the pill with water, and after waiting 30 minutes, would complete a 30-min mentally fatiguing protocol. They then performed a spatial reaction time test immediately followed by a marksmanship assessment using optical targetry.

    In addition, blood pressure was tested both before and after, and it was all completed a second time.

    Once again, the data will be released to the public in August of 2019, but given Compound Solutions’ push for Dynamine as a gaming supplement ingredient, we’re confident that this worked out well.

  • Upcoming Study 3: Acute Safety, Tolerability, Mood, and Pharmacokinetics

    Dynamine Supplement

    Dynamine goes beyond pre workout supplements. Prepare for energy drinks and mood boosters infused with the ingredient as well!

    Finally, a double-blinded, cross-over study of 12 subjects split into two groups was performed to evaluate the acute safety, tolerability, mood-enhancing effects, and pharmacokinetics (PK) of single oral doses of methylliberine at 25mg and 100 mg, both alone and in combination with caffeine and/or theacrine in healthy men and women.

    The groups:

    1. Dynamine 25mg
    2. Dynamine 100mg
    3. Caffeine 150mg
    4. Dynamine 100mg + caffeine 150mg
    5. Dynamine 100mg + theacrine 50mg
    6. Dynamine 100mg + theacrine 50mg + caffeine 150mg

    Similarly, the data will be released to the public in August of 2019. Needless to say, if GRAS status has been achieved, and the four-week safety study was successful, we’re confident a single dose showed high safety results as well.

What does it take to become GRAS

Here are the components of a typical GRAS Dossier, but it often goes far deeper than this:

  • Description and Characterization

  • History of Consumption

  • Manufacturing, Production, and Quality Management

    Includes Manufacturing Overview, Good Manufacturing Practice, Specifications, Batch Analysis, and Shelf-Life Stability.

  • Safety Assessment

    Dynamine Effects

    Compound Solutions CEO Matt Titlow’s stack: 200mg caffeine, 100mg Dynamine, and 50mg Theacrine. Give it a shot and you will agree!

    Includes Toxicological Evaluation, Bacterial Reverse Mutation Assay, Chromosomal Aberration Study, Mouse Micronucleus Study, a Fourteen-day Repeated-Dose Oral Toxicity Study, and a Ninety-day Repeated-Dose Oral Toxicity Study.

  • Current Regulatory Status

  • Intended Use

  • Basis for GRAS Determination

    Includes both a Technical Element and a Common Knowledge Element.

  • Conclusion

  • Expert Panel

  • References

Compound Solutions provided all of the above — and more — in order to achieve this determination.

The implications of GRAS

Along with several expert opinions and research studies demonstrating that it’s safe even at high doses, this enables Dynamine-based products to reach a wider audience, especially at stores that require all ingredients to be fully compliant.

New markets, new venues

Dynamine Energy Drink Formula

Compound Solutions helps brands formulate their products. This is just the first page of a three-page document – contact CSI for the rest!

Major grocery stores (which is why Compound Solutions CEO Matt Titlow brought up energy drinks) and sites such as Bodybuilding.com are two major places where we may now see Dynamine-based products from our favorite brands.

Outside of the energy drink market, we see a strong push into the growing gaming supplement market with Dynamine.

This also serves as strong legitimacy for the supplement industry, which has had some legal troubles regarding other stimulatory ingredients. Compound Solutions’ work shows that there are supplement-centric companies working hard to comply with the letter of the law, and provide brands who also wish to do so a strong option.

Finally, we’d like to close off by congratulating Compound Solutions and the Dynamine patent-holders on their efforts. We understand that GRAS status can be greater than a million dollar investment, and given the incredible profile of this ingredient, it seems like it will pay off for everyone involved, both brands and consumers alike.

Stay tuned to PricePlow’s Dynamine and Compound Solutions News

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About the Author: Mike Roberto

Mike Roberto

Mike Roberto is a research scientist and water sports athlete who founded PricePlow. He is a biohacker with extensive experience in supplementation and dietary modification, whose personal expertise stems from several "n=1" experiments done on himself.

Mike's goal is to bridge the gap between nutritional research scientists and non-academics who seek to better their health in a system that has catastrophically failed the public.

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References

  1. Michaela G. Alesi, Matthew T. Stratton, Alyssa R. Bailly Alyssa J. Holmes, Andrew Modjeski, Megan Barie, Yuri Feito, Gerald T. Mangine, Karleena R. Tuggle, Tiffany A. Esmat, Garrett M. Hester, Katy Hayes, and Trisha A. VanDusseldorp; “Effect of Dynamine™ With and Without TeaCrine® Over Four Weeks of Continuous Use on Cardiovascular Function and Psychometric Parameters of Healthy Males and Females”; Presented at the International Society of Sports Nutrition; June 2019; https://blog.priceplow.com/wp-content/uploads/dynamine-abstract-issn-june-2019.pdf

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