Import Alert 66-35
(Note: This import alert represents the Agency’s current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert Name:
Reason for Alert:
Dallas district has reported that some clinics in Nuevo Laredo, Mexico are engaged in the business of selling potentially dangerous combinations of otherwise possibly useful drug products to U.S. citizens for weight loss.
According to newspaper accounts, the diet regimen consists of several drugs including diuretics, laxatives, thyroid hormones, depressants and antihistamines. The primary drug associated with the diet regimen is called Redotex, manufactured by Medix, a Mexican pharmaceutical company. According to the Mexican Diccionario de Especialidades Farmaceuticas (Mexican equivalent to PDR) each capsule of Redotex consists of the following:
English Translation (Spanish)
o Tri iodothyronine (Triyodotironina) 75 mcg. A hormone used to increase the metabolic rate of tissues.
o Norpseudoephedrine (Clorhidrato de D Norseudoefedrina) 50 mg. An amphetamine like drug.
o Atropine sulfate (Sulfato de Atropina) 0.36 mg. Used as a respiratory and circulatory stimulant.
o Aloin (Aloina) 16.2 mg. Laxative.
o Diazepam (Diacepam) 8 mg. A depressant (Valium).
Other drugs associated or used in conjunction with Redotex include:
1) Ponderex 40 (Clorhidrato de Fenfluramina) 40 mg. Manufactured by A.H. Robbins de Mexico
2) Moduretic Manufactured by Merck Sharp and Dome de Mexico.
3) Asenlix (Clorhidrato de Clobenzorex) 30 mg. Manufactured by Grupo Russellsa Mexican Pharmaceutical Co.
4) Ionamin (Complijo de Resina de Fentermina) (equivalente a 30 mg. de fenil ter butiliamina) 142 mg., manufactured by Pennwalt Labs de Mexico.
5) Fluddro Furosemide
The products normally given to patients consist of Redotex and product number 1 and number 2 listed above. Products 3 and 4 listed above have been reported to be substituted for Redotex in some instances. Newspaper accounts have also reported the occassional use of product 5.
A health hazard evaluation by CDB of the product Redotex has revealed that the use of Redotex poses a health hazard, especially when taken without adequate medical supervision. The irrational combination of these thyroid, diurectic, stimulant and tranquilizer drugs may cause serious and potentially fatal adverse reactions. These would include alteration of metabolic rate, increased heart rate, lowering or increasing of blood pressure, loss of body electrolytes by diuretic action, as well as confusion and hallucinatory states. Note: Charge statement revised on 04/23/2019.
Districts may detain without physical examination all entries, including those encountered by U.S. Customs during routine examination of personal baggage, of Redotex; and the other diet drugs mentioned above if encountered in combination with Redotex and charge: “The article(s) are violative within the meaning of 801(a) (3) in that it appears to be a new drug without an approved New Drug Application (NDA) pursuant to section 505; and it is misbranded under Section 502.”
Alert your local Customs of FDA’s interest in these products, however, emphasize to Customs that FDA’s interest regarding examination of personal baggage is limited only to routine examination.
“The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA) [Unapproved new drug, Section 505(a)]”