Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Region VI

November 14, 1985
86-DAL-4

Office of the Regional
Food and Drug Director
3032 Bryan Street
Dallas, Texas 75204-6191
Telephone: 214-767-0317

REGULATORY LETI'ER

CERTIFIED MAIL -
RETURN RECEIPT REQUESTED

Elmer Heinrich, President
The Rockland Corporation
d/b/a Rockland International
12215 E. Skelly Drive
Tulsa, Oklahoma 74128

Dear Mr. Heimrich:

An inspection conducted on July 10, 1985 of your facility at the above address by our investigators has determined that your firm is marketing the product, BODY TODDY. Promotional material (labeling) distributed with the product states or suggests that BODY TODDY is useful in treating hemorrhaging ulcers, sciatica rheumatism (sic), various skin disorders, varicose veins, sore throat, thyroid trouble, gum blisters, sclerosis of the liver, leukemia, enlarged spleen, anemia, low blood pressure, sexual potency problems and for cleansing the circulatory system.

Because such labeling includes statements which represent and suggest that the article is intended to be used in the cure, mitigation, treatment or prevention of disease, or is intended to affect the structure or any function of the body of man, this product is a drug as defined in section 201(g) of the Federal Food, Drug and Cosmetic Act. F'urther, we are unaware of any substantial evidence which demonstrates that this drug is generally recognized as safe and effective for its intended use. Accordingly, continued marketing of this drug is a serious violation of the Federal Food, Drug and Cosmetic Act as follows:

SECTION BRIEF DESCRIPTION
502(a) The aforesaid article of drug is misbranded in that its labeling is false and misleading by representations and suggestions that there is substantial scientific evidence to establish that the article is safe and effective for the treatment of hemorrhaging ulcers, siatica rheumatism (sic), various skin disorders, varicose veins, sore throat, thyroid trouble, gum blisters, sclerosis of the liver, leukemia, enlarged spleen, anemia, low blood pressure, sexual potency problems and for cleansing the circulatory system.
502(f)(1)

The article of drug is misbranded in that the labeling fails to bear adequate directions for the use for which the article is represented or suggested (as described above), and it is not exempt from this requirement under regulation 2l CFR 201.115 since the article is a new drug within the meaning of section 201(p) and no approval of an application filed pursuant to section 505(b) is effective for this drug.

The article of drug is further misbranded in that its labeling does not contain adequate directions for use as this term is defined in 20 CFR 201.5 since the conditions for which it is offered are not amenable to self diagnosis and treatment by the laity: therefore adequate directions for use cannot be written under which the layman can use this drug safely and for the purposes for which it is intended.

505(a) The aforesaid article is a drug within the meaning of section 201(g) of the Act which may not be introduced or delivered for introduction into interstate commerce under Section 505(a) of the Federal Food, Drug, and Cosmetic Act, since it is a new drug within the meaning of section 201(p) of the Act and no approval of an application filed pursuant to section 505(b) is effective for such drug.

The violations listed above are not intended to be all-inclusive. It is your responsibility as a drug distributor to market drug products which are in compliance with the Federal Food, Drug, and Cosmetic Act.

We request that you reply within ten (10) days of your receipt of this letter stating the action you will take to discontinue the marketing of this drug product. If such corrective action is not promptly undertaken, the Food and Drug Administration (FDA) is prepared to initiate legal action to enforce the law. The Federal Food, Drug, and Cosmetic Act provides for seizure of illegal products or injunction against the manufacturer or distributor of illegal products (21 USC 332 and 334).

Your reply should be sent to the Food and Drug Administration, Dallas District Office, 3032 Bryan Street, Dallas, Texas 75204, Attention: Philip R. Lindeman, Compliance Officer.

Sincerely yours,

Donald C. Healton
Regional Food and Drug Director

PRL/vw

This page was posted on Novembe 26, 2006.

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