Inspections, Compliance, Enforcement, and Criminal Investigations
Yamila Abraham 02-Jan-02
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 596-7896
VIA FEDERAL EXPRESS
January 2, 2002
102 Vernon Street
Apartment No. 3
Worcester, MA 01610
Dear Ms. Abraham:
During an inspection of your business facility, located at 102 Vernon Street, Worcester, MA on April 3, 4 and 9, 2001, our Investigator documented that you distribute a number of products that are promoted as alternatives to illicit street drugs.
In addition to brand names or label claims that may promote your products as street drug
alternatives, your Internet website at http://www.pleasureherbs.com also promotes the following products with claims the products are useful as alternatives to illicit street drugs. This list is not all inclusive:
Ecstasy ek-sta-sis: "Herbal Ecstasy. The most discriminating connoisseurs of Herbal XTC love this one. The strongest one we sell, may be too much for some metabolisms.though DO NOT LOAD on these pills."
Rush: "Ecstasy Rush 2-3 tablets, empty stomach. Get higher and higher."
Pure: "Ecstasy Pure 2 tablets, empty stomach. Insanely happy happiness."
Magic Mushroom: "Herbal Hallucinogen. Contains real psychedelic Mushrooms and
Ephedra: Good trippy fun.
Ecstasy White Powder: "Columbian Style White Snuff. White Powder. Columbian style."
Bliss Extra: "SuperEcstatic Sensory Overload. Bliss Extra Herbal Ecstasy Bliss extra is a
great MDMA-like product. If you liked XTC, do your brain a favor and switch to Bliss
Tripadelic: "Spacey Japanese psychedelic, Effects are crazy "sinking" loss of balance,
***giggly euphoria. *** Has Chtlchuhuasi: muscle relaxer, adrenal gland stimulant, Lettuce Opium, Cannabliss Mugwort & Psychedelic Mushroom."
Weed X / Herbal XTC: "Weed X my friend. It is bar none the best marijuana alternative.
*** If taking pills scare you then go for the Cannabliss. Weed X feeling is similar to
Cannabis. Lasts as long, feel as strong. No paranoia. No brain rot. Lightly psychedelic."
Yellow Jacket: "Yellow Jackets are a great stimulant for day to day use."
Roadrunner Super: "Total amphetamine-like euphoria."
Druids Fantasy: "Time to fly. Dark Psychedelic. *** Has D-lysergic amide taken from
Morning Glory Seeds. Magic Mushrooms has legal psychedelic mushrooms in it. Space
Cadets or Druids Fantasy are also good alternatives. I don?t know why anyone would eat
Morning Glory Seeds to get high when there are so many palatable legal products out there. Space Cadets and Druids Fantasy have the LSA compound in them."
Lust: " *** like the other THHC products (Druids, Bliss, Cadets) a little trippy."
Sunkissed: " I want to trip but I?m afraid I?ll black out or do something crazy. The only ?thing we sell that will do that is the Salvia 5X. other hallucinogens we sell like Sunkissed
and Tripadelic do not cause blackouts when it is used responsibly. Euphoriant, hallucinogen, inebriating:. *** This contains a potent hallucinogen called arazone *** Arazone is the substance used to make TMA-2. It is extremely potent in large doses."
Salvia 5X: "I want to trip but I?m afraid 1?11black out or do something crazy.. The only ?thing we sell that will do that is the Salvia 5X. Other hallucinogens we sel++ike Sunkissed and Tripadelic do not cause blackouts when it is used responsibly."
Kannabliss: ?"Weed X my friend. It is bar none the best marijuana alternative. If taking
pills scare you then go for Cannabliss."
Catmint: "An intoxicant and mildly hallucinogenic."
Buddha?s Blend: "Ancient blend of herbs may contain ***Lopium, Prickly Poppy,
California Poppy *** The effects of Buddha?s Blend vary with each person and their
The Bulldog: "Use in moderation. This stuff is strong, so don?t fool around."
Proze-smoke: "The effects of smoking St. John?s Wort vary with each person but generally induce a mental calming."
Demonphilia: "Psychotropic Herbal Blend."
Space Cadets: "DO you have anything that feels like tripping on Morning Glory Seeds? I
don?t know why anyone would eat Morning Glory Seeds to get high when there are so many palatable legal -products out there. *** space cadets and Druids Fantasy have the LSA compound in them. Magic Mushrooms has legal psychedelic mushrooms in it. Space Cadets and Druids Fantasy are also good alternatives. Same D-Lysergic acid amide as Druids, but has strong stimulants. *** like the other THHC products, *** a little trippy."
Based on the claims cited above, the products are "drugs" as defined in Section 201(g) of the Federal Food Drug and Cosmetic Act (the Act). Even though the labeling may claim that they are dietary supplements, they do not fall within the scope of claims permitted for such products. Moreover, they are also "new drugs" (Section 201(p) of the Act) because there is no such evidence that these products are generally recognized as safe and effective for their intended uses. Since these products are "new drugs" they may not be legally marketed in the United States without an approved New Drug Application (Section 505(a) of the Act).
This letter is not intended to be an all-inclusive list of violations at your facility. You are
responsible for ensuring that all Products marketed by your firm are in compliance with "
applicable United States laws.
We request that-you take prompt action to correct these violations. Failure to promptly correct violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Federal Food, Drug, and Cosmetic Act provides for seizure of illegal products and for an injunction against the-manufacturer and/or distributor of illegal products.
You must notify this office in writing, within fifteen (15) working days of your receipt of this letter, of the specific actions you have taken to correct the stated violations. You should also include an explanation of each ?step you have taken to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made.
You may direct your reply to Karen N. Archdeacon, Compliance Officer, at the address noted above. If you have any questions concerning this letter, please contact Ms. Archdeacon at (78l) 596-7707.
Gail T. Costello
New England District Office