The FDA, Big Pharma and CBD from Hemp CO2 Extract: Will CBD Be Banned?

Legally grown "industrial" hemp, source of CBD CO2 extract.

It was recently reported by Natural News that the FDA intends to ban CBD as a nutritional supplement, and is “waging war” against this and all cannabis extracts. Why? Because “Big Pharma” has synthesized CBD and is beginning its push to having it approved as a new drug.

We’ve written these these posts to introduce you to CBD:

CBD is available in Ananda’s 5 CBD formulas: CBD 100, CBD Plus, CBD x3, CBD Calm and CBD DeFlame.

A Summary of the FDA & CBD Controversy

  • CBD (cannabidiol) is the most abundant naturally-occurring cannabinoid in 100% legal “industrial” hemp. This is the same plant which provides hemp seeds, hemp seed oil, hemp fiber and hemp protein.
  • CBD has been positively researched for its benefits for a wide variety of health conditions in over 350 scientific studies, published in peer-reviewed journals.*
  • CBD has been synthetically produced by GW Pharmaceuticals. This company had submitted application to the FDA for an Investigation as a New Drug (IND) in 2014.
  • The FDA prohibits sale of a molecule or compound as a dietary supplement if an IND had been applied for prior to its marketing as a supplement.
  • However, CBD was in fact marketed as a supplement long before an IND was applied for by GW Pharmaceuticals with the FDA.

CBD Research Results are Solid Enough for Big Pharma to Pursue it as a New Drug

CBD has clearly demonstrated efficacy in reduction of epileptic seizures, with great safety, in a series of studies reported by the American Epilepsy Society in www.ScienceDaily.com. CBD has, in fact, shown promise in support of a great many health conditions*, and Big Pharma is eager to make a profit…and so is the FDA.

GW Pharmaceuticals has applied for a New Drug Investigation with its synthetic Cannabidiol for treatment of severe epilepsy in children. Both GW Pharmaceuticals and the FDA would like to see this proceed in the “normal” fashion. The reason why is obvious…

How the FDA Get’s Paid

In 2010, the total cost of review and approval of a new drug was approximately $500M. Yes, that’s right, about $500,000,000 dollars are paid by a drug company to the FDA for new drug review and approval. And there’s been a record number of new drug applications this last year than ever before. Approving new drugs is one of the primary ways the FDA stays in business, and it’s not about to let go of this income source anytime soon.

What, Now, is the Legal Status of CBD?

The controversy surrounding the banning of CBD as a nutritional supplement – and perhaps why CBD may actually remain available as a supplement – is that by the FDA’s own rules, it should be “legal” to sell in this manner. It remains to be seen what will result in this battle between the hemp industry and the FDA.

The FDA’s “crackdown” on CBD has been to send warning letters regarding labeling to the largest CBD distributors in the Country. It has, as of yet, left open the outright banning of sale of this ingredient. Because CBD is simply concentrated from 100% legal industrial hemp through CO2 distillation, it’s difficult to imagine its sale being stopped. The FDA can prevent it from being marketed as a supplement, though there will certainly be very significant resistance from the hemp and cannabis industries.

We are of course  offering our CBD formulas, including ingestible essential oils and CO2 extracts which may work in concert with CBD.

See all of Ananda Apothecary's synergistic CBD formulas here...

*These statements have not been evaluated by the FDA. These products are not intended to diagnose, treat, cure, or prevent any disease.

 

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Best Practices for Storing Your Essential Oils

We’re often asked what the “shelf life” of our oils are, or of a particular oil, as well as how best to store essential oils for their longevity. Here’s the scoop on how best to care for your oils!

Bergamot Fruit

Bergamot fruit, from which the incredible sweet-tart essential oil is pressed. One of the 'citrus' oils, which should be carefully stored if kept for more than 6 months.

The shelf life of essential oils is a complicated question. First because each oil has a different shelf life. Much of that has to do with how the oils are stored, and some oils improve with age!

What Does “Shelf Life” Mean for Essential Oils?

First, what does “shelf life” mean for essential oils? The truth is they don’t go “bad” as a carrier oil could (which we’ll get to in a bit). They can, over time, loose a sense of freshness, and could smell “flat” or less lively.

For example, the oils which can “go flat” fastest, if not properly cared for, are the cold-pressed citrus oils: Grapefruit, Lemon, Lime, Orange, Bergamot and Mandarin. This is because they’re pressed directly from the fruit, without ever being heated — so they’re in the most natural state of all essential oils. These oils are considered to have a shelf life of anywhere from 6 months to a year, yet this only means they loose some of the freshness in their aroma, not that they “go bad” as the term is commonly understood.

For long-term freshness however, the citrus oils should be used within their first 6 months of purchase, or stored in the refrigerator if you expect to keep them longer.

Lavender

Lavender: One of the few floral oils you should ensure proper storage of if it will be topically applied.

A couple specific oils have been shown to cause skin irritation in a small amount of the population if they’ve oxidized, if kept for over a year improperly stored. Scientific examination has shown this can happen with Tea Tree and Lavender, though thus far these are the only ones known to do this. (The study discussed oils that are an ingredient in a cream or other compound, where you can imagine the life of the oil: shipping from the distiller, to the manufacturer, to the store — and at each point the oil could sit for some time). Compare these to Helichrysum for example, which doesn’t necessarily have a shelf life — it’s aroma improves over the first year, and it doesn’t oxidize in a way that causes irritation of any sort.

Frankincense Trees

Boswellia trees, the source of Frankincese...an oil that can improve with age.

As you can see, “shelf life” means different things for different oils. For most oils, it really comes down to their aromas being as fine, bright and potent as they were when they were fresh. Looking at it this way, the cold-pressed citrus oil have the shortest shelf life, then some of the floral oils (though not really Rose or Jasmine), herbal, and conifer needle oils.

Oils Which Age Well

Then we get to the woods and resins: Cedarwood, Frankincense, Myrrh — these can age quite nicely. And some oils are more highly valued the older they get: Sandalwood and Patchouli are the most renown of this group.

Storage Conditions and Shelf Life

Given all that, the storage conditions of your essential oils makes a huge difference in how long they’ll stay fresh (when we’re talking about oils that don’t necessarily improve with age). Grapefruit, kept in a tightly capped bottle, with as little “air space” as possible, in a dark cabinet, refrigerator, can be kept for at least two years (perhaps longer) without any change in the aroma. Even if not kept “cold”, but still in a dark cool cabinet, it’s likely there would be no detectable change even for a year.

So essentially, if you’re buying oils you plan on using up within a year, there’s really no concern about shelf life at all, should you store your oils properly. And for all oils other than the cold-pressed citrus, this extends to two years or more.

The factors which age an oil are heat, light, and oxygen. Hence the ideal condition being in a cool, dark place, capped tightly. And should you decide to refrigerate your oils, though use them frequently, it would be best to pour yourself a smaller bottle that’s not kept refrigerated, as taking the oil from cool to warm to cool to warm (etc.) isn’t ideal (frequent change in temperature can affect the oils too, and they can collect moisture if this is done often as well).

The bottom line is that as long as you’re storing your oils properly, there’s really no reason to be concerned about their “shelf life”, should you expect to use them within two years of their purchase.

Shelf Life and Carrier Oils

Carrier oils are more like food than essential oils. Some can go rancid, and some do this faster than others. Oils with the most unsaturated fatty acids are the most sensitive. Hempseed, with it’s high amount of omega-3′s, Sunflower, Borage Seed, Rosehip Seed, Avocado, and Evening Primrose oils are best kept refrigerated if they’ll be kept for longer than a month.

At the other end of the spectrum, Jojoba and Fractionated Coconut last for years, without need for keeping them cool. And to extend the life of ALL carrier oils, you can add a few drops per ounce of vitamin E, or even better, Rosemary Antioxidant (it’s more effective because of the way it quenches oxidative radicals). This is a good idea when making blends that may not be used very quickly as well.

We hope this helps you understand about shelf lives and essential oils! It is a complicated subject, because each oil ages differently. At the same time, it’s easy to keep them fresh, simply by with proper storage.

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5 studies concluding ingesting Lavender capsules safe & effective (and they’re easily made at home!)

A series of five studies has positively evaluated the safety and efficacy of 80mg (about 3 drops) of Lavender essential oil ingested in a capsule per day.

Researchers conclude Lavender essential oil resulted in significantly better sleep, relief from anxiety ~ and one study in this series notes Lavender use “pronounced antidepressant effect and improved general mental health and health-related quality of life”.

The formulation studied is simply 3 drops of pure lavender in a gel capsule, which is easily made at home. Buy yourself empty gelatin or cellulose capsules, and use a small dropper (removing any orifice reducer from your bottle first) and add 3 drops in a capsule.

All of our Lavenders are from Lavendula angustifolia, the species highest in Linalool and Linalyl Acetate, considered in this research the most 'active ingredients'.

We have found better results when taking this on an empty stomach, and only a little bit of burping-up lavender when taken with food.

These studies appear validate the anti-anxiety and sleep supportive nature of Lavender essential oil in general, as other studies have noted when the oil was inhaled or applied via massage. Lavender oil both diffused and topically applied are actually absorbed in the bloodstream. We think it is very interesting you don’t have to smell it to work. (Scroll down to see the studies and the researcher’s conclusions for each).

According to Robert Tisserand in “Essential Oil Safety”, oral ingestion of an essential oil increases absorption by about 10 times compared to topical application. And lavender is noted in as to be non-toxic and non-sensitizing in this and other literature.

In summary, the “take home messages” are that:

  • Lavender essential oil is safe for ingestion in the amounts tested (up to 160mg/day ~ about 4 drops).
  • Lavender essential oil taken once daily in a capsule significantly improved sleep quality.
  • Lavender was found as effective as prescription sedatives (benzodiazapines, such as Valium) for anxiety relief and sleep, without side effects or the potential for addition.
  • Lavender was found as effective as prescription anti-depressants (compared to Paroxetine, ie. Paxil) at relief of GAD – ‘generalized anxiety disorder’ – with markedly lower adverse affects (“AE” in the research).

Lavender essential oil is distilled from lavender flowers ~ the best is considered from France, as is our High Elevation and Wild varieties.

These human studies have been randomized and placebo-controlled, ensuring the validity of the results. This means participants were randomly selected to either receive lavender, placebo, or comparable pharmaceutical preparation. In some cases the control was anti-depressant, and others a benzodiazapine – the anxiety-relief ‘gold standard’ in Western medicine.

 

Finally here’s the titles and conclusions of the 5 studies, in chronological order:

  1. Title: A multi-center, double-blind, randomised study of the Lavender oil preparation Silexan in comparison to Lorazepam (Valium) for generalized anxiety disorder. Published in Phytomedicine. 2010 Feb;17(2):94-9.

    The authors concluded: “In conclusion, our results demonstrate that silexan is as effective as lorazepam in adults with GAD. The safety of silexan was also demonstrated. Since lavender oil showed no sedative effects in our study and has no potential for drug abuse, silexan appears to be an effective and well tolerated alternative to benzodiazepines for amelioration of generalized anxiety.”

  2. Title: Efficacy and safety of silexan, a new, orally administered lavender oil preparation, in subthreshold anxiety disorder – evidence from clinical trials. Published in Wien Med Wochenschr. 2010 Dec;160(21-22):547-56.

    The authors concluded: “Across all trials 280 patients were exposed to silexan 80 mg/day, 37 were treated with lorazepam 0.5 mg/day and 192 received placebo. Average within group HAMA total scores at baseline ranged between 24.7 and 27.1 points. Patients treated with silexan showed average HAMA total score decreases by between 10.4 ± 7.1 and 12.0 ± 7.2 points at week 6 and by between 11.8 ± 7.7 and 16.0 ± 8.3 points at week 10. In GAD silexan and lorazepam showed comparable HAMA total score reductions”

  3. Title: An orally administered lavandula oil preparation (Silexan) for anxiety disorder and related conditions: an evidence based review. Published in Int J Psychiatry Clin Pract. 2013 Nov;17 Suppl 1:15-22.

    The authors concluded: In patients with subsyndromal anxiety or generalised anxiety disorder (GAD) an anxiolytic effect of Silexan was evident after 2 weeks. Patients treated with Silexan showed Hamilton Anxiety Scale (HAMA) total score decreases between 10.4 ± 7.1 and 12.0 ± 7.2 points at Week 6 and between 11.8 ± 7.7 and 16.0 ± 8.3 points at Week 10.

  4. Title: Lavender oil preparation Silexan is effective in generalized anxiety disorder–a randomized, double-blind comparison to placebo and paroxetine. Published in International Journal Neuropsychopharmacol. 2014 Jun;17(6):859-69.

    The authors concluded: Silexan showed a pronounced antidepressant effect and improved general mental health and health-related quality of life. In GAD Silexan is more efficacious than placebo. AE rates for Silexan were comparable to placebo and lower than for the active control paroxetine.

  5. Title: Efficacy of orally administered Silexan in patients with anxiety-related restlessness and disturbed sleep – A randomized, placebo-controlled trial. Published in European Neuropsychopharmacol. 2015 Aug 7. pii: S0924-977X(15)00242-4.

    The authors concluded: In all outcome measures the treatment effect of Silexan was more pronounced than with placebo. The study confirms the calming and anxiolytic efficacy of Silexan.

 

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