Cannibidiol label claims

OK you folks, I rarely ask a question of anyone ("I give and I give, but rarely do I get"), but here is one for the forum.  The label "protocol" established here in North America for topical products bearing CBD typically states "XX mg CBD" in this or in that, usually just "XXX mg" or "XX mg per pump". Excuse my street patois, but WTF is going on here? If you do the math, nobody is putting 250mg of actual, pure, broad-spectrum CBD into a 2 oz. jar and selling a lot of it, for the simple logic that there isn't enough CBD to consistently supply our industry - yet. (Canada is working on it.) My presumption is this: they are stating the mass in mg of CBD as a blend in a carrier, or they are outright lying to the end-user in their eager attempt to profiteer in this mad CBD gold rush environment. Or, just maybe they just cannot do the math - not an uncommon attribute here in the U.S.A., I am chagrined to say. Your educated opinions are encouraged.

Comments

  • Ain't Cannabidiol a controlled substance?

    According to Wikipedia it's Schedule I, except for some low concentration formulations that are Schedule V
    https://en.wikipedia.org/wiki/Cannabidiol

    Although CBD doesn't seem to be clearly listed
    https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf

    Several papers say CBD remains illegal
    https://www.brookings.edu/blog/fixgov/2017/02/06/cannabidiol-illegal-and-always-has-been/

    and so says a court
    https://eu.statesmanjournal.com/story/news/2018/05/04/court-rules-cbd-cannabidiol-schedule-1-controlled-substance-marijuana-pot/580835002/

    So, at the end
    trust no one, don't even trust lawyers
    it looks like you'll have to ask the DEA directly for clarification.

    BTW how much do DEA chemists typically make a year?
  • edited October 2018
    Hemp-derived CBD oil is approved in all 50 States and has a low THC yield (less than 0.3% THC present.)

    Cannabis-derived CBD oil is available in US States with Medical and/or Recreational Hemp laws such as CA and CO. Many studies have shown that the cannabis-based CBD is superior due to the presence of the THC (20:1 CBD/THC or 10:1 CBD/THC). The Israeli studies and anecdotal evidence supports the need for the THC as part of the "entourage effect."

    We pushed for 25-50mg per metered dose.

    The DEA doesn't monitor CBD or THC in products but merely Interstate Transport across State lines. The FDA has ignored the issue essentially.

    Of note, in Canada where it is legal and treated as a Medicinal product, it is no longer allowed in Cosmetic products. There was a recent article pertaining to this issue in C&T recently.
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications.
  • I did not inquire about the legal status of CBD, guys, nor its efficacy attributes; those I know well - and yes it is still Schedule 1 status as of today. I am interested in knowing the market label logic and presumptions about dosing that it implies. Mark, you partially answered, so thanks. Your client no doubt has to decide what mass "metered dose" is. From what I gleaned, and unless another party weighs in here, these label claims are just bull$&!#. I can put 0.01% w/w into a 60g jar and advise a client to  label it "200mg CBD", even though it only contains 6. Who's to know and who's to care? It becomes a morality question only.
  • I'm sure most are stating a certain percentage, but in actuality, is much lower. Really hard to say how they are dosing for certain. I have worked with dispensiaries, and many are not honest... Could be 1000mg, but that was made in a batch of 5 gallons of oil etc. So actual dosage in a one ounce bottle for instance will obviously be less. 
  • I would expect it to be the amount in carrier, not living in the US i went to google and found only few claiming use of pure cbd.
    Unless everyone else use standardized extracts I presume they state the amount of total extract with/without excipients. Just like many small producers list an extract in the top, not considering the solvents used.

    But it is difficult without puchasing and analysing to say if they actually tell the truth.
    Dabbling Formulator — Qualified Cosmetic Safety Assessor — experienced in claim substantiation & EU regulatory affairs.
  • edited October 2018
    The claims (as touted) are bull as pointed out. I hold out hope that once adequately investigated it will have some legitimate uses, likely based upon ingested CBD not topical.

    As far as claiming a wide variance in the CBD products, that is for the most part in the past. The States where the cannabis based is legal the products are required to be tested, cGMP to be followed and for the final products to be consistent from batch to batch. To prove this assertion to yourself, read the 137-page Medical Regulations California issued December 2017. The Industry is generally moving to a more sophisticated standard.


    Many products I have consulted on were for edibles (easy to control actual dosage), and topical products. They general settle on a standard %wt/wt percentage (say 25mg/5 grams perhaps) and then generally recommend a "pea-sized" amount. Obviously, this is much cruder.


    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications.
  • I'm now thinking about this quite hard, because I bought both cbd oil and cream for my back. I have degenerative discs disease and NSAIDS used regularly give me rebound headaches.

    Creams and lotions are measured in volumes, not weight, correct?

    So the cream I own, 500mg 2oz, is claiming to be 8.45mg of CBD per ml of cream

    I'm going to have to do stoichiomtry to figure out if I've been ripped off, aren't I?
  • I am working on a couple of CBD projects at the moment.  Unless you can get pure CBD that is not in a carrier, you're going to have to use a CBD loaded at 1,500 mg per fluid ounce of hemp seed carrier oil ... that's roughly 1,500mg CBD in 30 grams of carrier oil.

    To get a load of 250 mg CBD in 100 grams of product, you would have to use such a high load of CBD in carrier oil that ... you'd have to make a cream with a 50% oil phse  ... see what I'm talking about Vern?

    So, when they list 150 mg CBD, it's generally the amount of CBD in the carrier oil base, not the load of CBD in the end product.  But, again, if you can get pure CBD, then you can load at accurate level, if you can afford it.
    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    Provides Formulation Development and Lab-Scale Contract Manufacturing Services.  See website for details www.desertinbloomcosmeticslab.com

  • After doing a little more research it looks like the target dose is about 8mg-22mg, depending on the size of the person. So I'm at least at the low end of that. 

    But this method of listing concentration is intentionally misleading and imprecise at best. I think I'm going to look up medical studies of CBD tomorrow and see what dosages were being used.
  • I am working on several CBD projects too and we are primarily using CBD pure isolate at $10,000 kg. The requests are between 50-100 mg/oz product. They send each batch we manufacture in to test, ensuring their specified amount is in each. Honestly I know very little about this CBD isolate except it incorporates well into the oil phase. Lol.  Such a lame marketing bubble as we also incorporate other “actives” that really do the job such as menthol, etc.
  • I was ready for it to not work at all, but surprisingly it does reduce my pain when applied to specific areas. I also have a sublingual supplement that's 1000mg in 30ml.

    The sad part is there is very little research on its transdermal absorption, so we're going into this blind as scientists. The half life of a sublingual dose seems to be 1.44 hours
  • And menthol didn't help my pain AT ALL. I slathered on enough biofreeze to send me running for a hot shower to warm up when my pain is muscle based. It did nothing 
  • We're going off our suppliers statement of 30% CBD added to MCT oil, and calculating the mg per the whole container.  It's very pricey, like @Gene mentioned. 
  • That's actually a really good price on isolate.It's super expensive. I'm hoping the price will drop a bit because of this year's farm bill, but not so much it hurts small farmers who've gotten the industry off the ground
  • Small farmers will not be significant in the Market in 4 to 6 years. The bug companies such as Alliance One and Pyxus are making huge investments and they are producing the product to a much higher level of purity.
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications.
  • I’m hearing rumors some XYZ Pharmaceutical Company has a patent on the process of CBD isolate. Don’t hold your breath on market or price..... I think this whole market is in for some surprises. My opinion on functionality is its still placebo. But hay, let’s make hay while the sun shines. 
  • There is no rumor. There is a CBD analog Epidiolex (cannabidiol) [CBD] oral solution approved by the FDA. It is NOT CBD properly. It has been altered slightly through Medicinal Chemistry to increase affinity for the receptors.

    I can say for sure without citing rumors that the Tobacco Companies are poised to transition to the cannabis and hemp-based CBD Markets and are heavily invested with money and talent. They will likely dominate the market in 4-6 years.
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications.
  • It is ironic that the same industries that were behind the push to declare Marijuana and Hemp as illegal substances in the US are now looking to dominate the industry.
    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    Provides Formulation Development and Lab-Scale Contract Manufacturing Services.  See website for details www.desertinbloomcosmeticslab.com

  • I was always under the impression that it was due to Hearst owning many acres of Forest Land. He wanted to eliminate the use of hemp in paper for that reason. He was behind the appointment of Anslinger, https://www.massroots.com/learn/the-man-responsible-for-marijuana-prohibition/

    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications.
  • edited February 5
    It's bit more complicated than that and actually you're seeing it play out again in our current politics.

    Marijuana was introduced into the US by migrant workers from Mexico.  Yes, Anslinger was the point man, but his backing was by not only Hearst, but Tobacco, Liquor, Paper and Fabrics industries who all did not want Hemp to compete with their products.

    Anslinger used a variety of means to demonize both the migrant workers and marijuana ... the film "Reefer Madness" was actually a government propoganda film.  Remember, this is shortly after the Great Depression, so there is an undertone of railing against cheap immigrant labor in addition to demonizing hemp.

    You can hear it from the likes of Steve King & Trump ... the Mexicans are dangerous ... the marijuana makes them violent and they'll rape and pillage your women.  Same tactic we're seeing today.
    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    Provides Formulation Development and Lab-Scale Contract Manufacturing Services.  See website for details www.desertinbloomcosmeticslab.com

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