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

Public Health Service

 

Food and Drug Administration
Room 500 U.S. Customhouse
721 19th Street
Denver. Colorado 80202
303-837-4915

July 6, 1984

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Dr. Tei-Fu Chen
Chairman of the Board
The Sunrider Corporation
452 West 1260 North
Orem, Utah 84057

REGULATORY LETTER

Dear Dr. Chen:

An inspection of the Sunrider corporation was conducted on February 27-29, and March 8, 12, 13 and 19, 1984, by Investigators Darrell T. Lee and W. Robert Hollowell of this office. This inspection revealed serious violations of the Federal Food, Drug and Cosmetic Act. These violations include, but are not limited to:

SECTION

505 (a)

BRIEF DESCRIPTION

The accompanying labeling for articles of herbal I preparations manufactured and/or distributed by you under the "Sunrider" label included but not limited to: Technical Bulletin (TB) 8201, Nutrien Concentrate and Calli Tea; TB 8206 sun Breeze Balm 2/83; TB 8207 Prime Again 2/83; TB 8208 Lifestream 2/83; TB 8209 Assimilaid 2/83; TB 8210 Concold end Concold Syrup 2/83; "Do You Know Your Products;" Sunwriter; "How to Use the Sunrider Total Health Program;" and Sunrider, contains statements that represent and suggest the herbal preparations are adequate and effective for the treatment of various disease conditions; including , but not limited to the following:

Product labeled "PRIME AGAIN" capsules in conjunction with the aforementioned accompanying labeling — "*** strength¬ening of the heart, kidney, spleen, stomach and liver *** Increasing the red blood count *** aiding in the removal of toxic materials in the blood *** Improvement of the immune-response *** regulation of hormone secretion *** strengthens the *** Lungs , and adrenal glands *** Good for *** uterus *** antispasmodic *** expel poisons from the body *** treat *** ear ringing *** Regulates the adrenal glands *** a blood cleanser *** Reduces blood pressure *** Increases blood count and circulation *** useful in treating senility ***"

Product labeled "LIFESTREAM" capsules in conj unction with the aforementioned accompanying labeling— " *** Regulation of blood pressure *** Cleansing of the blood and reduction of extraneous clotting *** Improvement of the eyesight and reduction of redness of the sclera. (There is a close relationship between clarity of eyesight and the circulatory system) *** Strengthens the liver and kidney *** antispasmodic *** Excellent for reducing blood pressure and hypertension *** Strengthens the capillary system against inflammation *** Stops bleeding *** Strengthens the heart and the vascular system *** Strengthens the lungs *** Reduces the blood sugar level *** Regulates the pancreas *** Used to treat "food poisoning ***"

Product labeled "ASSIMILAID" capsules in conjunction with the aforementioned accompanying labeling — "*** used for *** vomiting *** gastric ulcers *** abdominal pain, and stomach distention *** Strengthens the spleen and lungs *** Strengthens the heart *** Antispasmodic stops cough and vomiting *** Strengthens the adrenal gland *** Good for ulcers *** Aids in skin diseases ***"

Products labeled "CONCOLD" capsules and "CONCOLD SYRUP" in conjunction with the aforementioned accompanying labeling — "*** Relief of fevers *** migraine headaches *** protect against influenza *** Strengthens the lungs and kidneys *** Strengthens the liver and gall bladder *** Regulates the circulation to relieve *** fluid - congestion *** bleeding *** Reduces blood sugar level *** Combats infections *** Antispasmodic *** reduction of blood pressure ***"

The use of therapeutic claims, such as those cited above, in the labeling for these articles causes than to be considered drugs within the meaning of Section 201 (g) of the Act; and in the absence of any substantial evidence that any of the articles are generally recognized as safe am effective for any of the recommended or suggested conditions they are new drugs within the meaning of Section 201(p) of the Act, and no approval of an applica¬tion filed pursuant to Section 505 (b) is effective for such drugs.


502 (f) (1)

The above articles are misbranded in that the labeling fails to bear adequate directions for use for which the products are represented and suggested and they are not exempt from this requirement under regulation 21 CFR 201.115 since the articles are new drugs within the meaning of Section 201(p) and no approval of an application filed pursuant to Section 505 (b) is effective for such drugs.


502 (o) The above articles are misbranded in that they are being manufactured, prepared, propagated, or processed in an establishment not duly registered as required under Section 510 of the Federal Food, Drug, am Cosmetic Act in that the establishment has not registered as a producer of drugs and has not listed each drug produced with the Food and Drug Administration as required under regulation 21 CFR 207.20.

We wish to reemphasize that the aforementioned products and others such as "CALLI TEA," and "SUN BREEZE BALM," are but examples of unapproved new drugs and misbranding claims for products being distributed by your firm. Since many of the medical conditions referenced in your labeling include serious disease conditions for which these products are not generally recognized as safe and effective, it is imperative that immediate steps be taken by you and your firm to assure prompt and complete corrective action. If such corrective action is not taken, the Food and Drug Administration is prepared to invoke regulatory sanctions provided under the law which include seizure and/or injunction.

Please be advised that drug products must be manufactured in accordance with current Good Manufacturing Practice as per Section 501 (a) (2) (B), Federal Food, Drug and Cosmetic Act. Enclosed please find a copy of 21 CFR 210 and 211 for your reference.

Please notify this office in writing, within ten (10) days following receipt of this letter, of the corrective action you have taken and are planning to initiate. You may direct your correspondence to Gary C. Dean, Compliance Officer.

Sincerely,

LeRoy M. Gomez
District Director

Enclosure

This page was posted on December 18, 2010.

Links to Recommended Companies