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FDA GRANDFATHER Clause Petition |
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EVIDENCE THAT MEDICAL CANNABIS
Was In Use AFTER June 25, 1938
REJECTION ISSUE #2:
The FDA’s original rejection letter stated that (the original FDA petition) offered NO PROOF that Medical Cannabis was indeed being marketed for medical use AFTER the passage of the Pure Food, Drug and Cosmetics Act of 1938. And as this proof was required for grandfathering, that this of-and-by-itself was reason for rejection.
However, since that time we have been able to document that such drugs did indeed exist. In fact, there were probably hundreds of them. The following serve as examples of Cannabis Medicines Sold and Marketed, under specific brand or trade names, ON-AND-AFTER June 25, 1938, that the petitoners have been able to document.
Only the issue of Post-June 25, 1938 dating will be addressed at this time.
Example 1: - Tablets Cannabinon as per the "Elmer & Amend" 1939 Pharmaceutical Price and Product Catalog:
Cannabinon Tablets:
As mentioned in the Eimer & Amend 1939 Price and product catalog. Due to the copyright date, it is obvious that this product was on the market after July 5, 1938.
Example 2: - Tablets Cannabin Compound; Marketed and sold by at least three different manufacturers:
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LABEL READS:
[Box] CANNABIN BELL (compound) A Nerve Tonic and Stimulant for the treatment of Mental and Physical Exhaustion, Depression, Insomnia, Neuralgin, etc.
DOSE. One tablet after each meal and at bed time. Gradually increase dose to two, four times a day, as directed by the physician.
[Bottle] ONE HUNDRED TABLETS CANNABIN BELL (coumpound), Ext. Cannabis gr. 1-8, Strychnia sulphate gr. 1-40, Zine Phosphide gr. 1-10, Holling-Smith co. (Sole successor to Bell & Co., Inc. in this preparation.) Manufacturing Chemists Orangeburg, N.Y., U.S.A.
Example 3: - Cannabis Tinture, manufacturered and marketed by the Lloyd Brothers Co.:
Because the petitioners are specifically requesting FDA grandfather approval of this product [Tincture Cannabis] some emphases on it is place
[click on image for more images]
Shown above is a bottle of Lloyds specific Cannabis tincture, which we have been able to document, was offered for sale from the year 1870 all the way up to 1941.
The following, all taken from sales literature from the Lloyd Brothers Co., is presented as proof that this product was being manufactured and sold on and after June 25, 1938:
First the reader should look over the following Price List [Click on Image] that was issued by the Lloyd Brothers Co. Note that the exact date is not actually present, but that there are references to the Marihuana Tax Act, which took effect on Oct. 1, 1937 less than 9 months from June 25, 1938. It is our belief that the price guide was issued in 1939. Unfortunately, because it is undated, of-and-my-itself it does NOT constitute proof, however, it does put some icing on the cake, which may be of some use to the legal types.
A Lloyd Brothers Product & Price Catalog [No. 53], which while undated makes reference in the past tense to the "Pure Food, Drug and Cosmetics Act of 1938." Note that it contains reference to Cannabis tincture. [under the trade copy-righted brand name, “Specific Medicines”]
A Lloyd Brothers Product & Price Catalog [Price list No. 54 - era 1941], (while undated note by the serial number that this catalog has been issued well after the passage of the "Pure Food, Drug and cosmetics Act") which again makes reference Cannabis tincture. [again, under the trade copy-righted brand name, “Specific Medicines”]
It is our belief that the above references more than proves that this brand named Cannabis Tincture was indeed being marketed and sold ON and AFTER June 25, 1938.
Example 4: - Generic (Bulk or Stand Alone) Cannabis Medicines:
By far the greatest use of “Document-able” post June 25, 1938, use of medicinal Cannabis is to be found in Old Pharmaceutical Trade Magazines, which catered primarily to the drug and pharmaceutical industry. Note, that bulk Cannabis, was still being offered for sale, until after 1939.
| YEAR | PAGE | PRODUCT |
| 1939 | pg 33 | Hemp Seed |
| 1939 | pg 51 | Extracts Powdered Cannabis USP |
| 1938 | pg 48 | Hemp Seed |
| 1938 | pg 59 | Fluid Extract Cannabis USP |
| 1938 | pg 60 | Extracts Powdered Cannabis USP |
| 1938 | pg 60 | Extract Solid Cannabis American USP |
| 1938 | pg 61 | Tincture Cannabis NF |
| 1938 | pg 46 | Cannabis Tannate |
Emphasis here should be made solely to the fact that bulk Cannabis was still being listed for (wholesale) well after June 25, 1938.
Additionally, there were numerous other post-1938 Cannabis Medical products (probably hundreds) that were being sold and marketed after June 25, 1938 as required for grandfathering. Hyoscinole-Cannabin[A] by Orion Pharmacal Co. (1721 E. 85th St. chicago IL) or Cannabis Cigarrettes by Grimault, just to name two. However, we believe that we have already made our point, that Medical Cannabis was indeed being marketed and sold ON-AND-AFTER June 25, 1938 as required for Grandfathering.
FOOTNOTES:
[A]- American Druggist Blue Book [1939] Pg144
[B]- Druggist Circular Red Book [Nov 1938] pg78
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