Inspections, Compliance, Enforcement, and Criminal Investigations
A Perfect Food Company, LLC 25-Aug-05
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|555 Winderley Place, Suite 200
Maitland, Florida 32751
August 25, 2005
RETURN RECEIPT REQUESTED
Ms. Karen Pignato, President
A Perfect Food Company, L.LC.
6920 SW 56th Court
Davie, FL 33314
RETURN RECEIPT REQUESTED
Michael Patriquen, Founder
Med Marijuana Inc.
1600 Bedford Highway
Bedford, Nova Scotia
B4A 1 E8
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.med-marijuanausa.com and has determined that the product Med-Marijuana™Cannabis Sativa is promoted for conditions that cause the product to be a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)]. The therapeutic claims on your web site establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
Examples of some claims observed on your web site include:
- "Cannabis Sativa . . . A Natural Health Choice! Rheumatoid arthritis, Fibromyalgia, Diabetes, MS . . . . Cannabis Sativa-the Marijuana plant-has been used by many suffering from those conditions, for all of that time."
- "Positive effects of low-THC Cannabis oil on Rheumatoid Arthritis"
- "Cancer Tumor shrinking abilities of non-psychoactive Cannabis."
- "Acting as a blood thinner, Cannabis Sativa has been reported to prevent the formation of blood clots which can [sic] heart attacks. Anyone with a family history of heart disease or is suffering from heart disease itself should be using this product daily to immediately assist their cardiovascular health which will help avoid a future cardiac event."
- "Acting as a vasodilator, Cannabis Sativa has been reported to open the veins of the body which helps prevent stroke while at the same time reduces blood pressure."
- "Diabetics taking our product tell us that they have tapered completely off Insulin, have normal sugar levels . . . ."
- "Clients using Cannabis Sativa in relation to their MS, Fibromyalgia and other painful auto-immune disorder symptoms have reported a major decrease or total elimination of their pain levels after continuing with the product for 30 to 90 days."
Furthermore, your product is not generally recognized as safe and effective for the above referenced conditions and therefore, the product is also a "new drug" under section 201(p) of the Act; [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Your Med-Marijuana™ is also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for this drug fails to bear adequate directions for use [21 U.S.C. 352(f)(1)].
This letter is not an all-inclusive review of your website and the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products [21 U.S.C. 332 and 334]. You should take prompt action to correct the violations identified in this letter and any other violations of the Act. Failure to do so may result in enforcement action without further notice.
Furthermore, this letter does not address whether the importation of your product into the United States, or the distribution of the product within the United States, is permissible under the Controlled Substances Act (21 USC 801 et seq.) and the Controlled Substances Import and Export Act (21 USC 951 et seq.), which are administered by the Drug Enforcement Administration.
Please advise this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your reply should be addressed to Shari H. Shambaugh, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751.
Emma R. Singleton
Director, Florida District