Warning Letter to Saturn-Chem

August 20, 2006

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

Public Health Service
Food and Drug Administration
Southwest Region
Kansas City District


11630 W 60th St
PO Box 15905
Lenexa, KS 66265-5905
Telephone: 913-752-2100

December 20, 1996

Jeffrey Topper, Owner
2206 W Hwy 76
Branson Mall #9
Branson, MO 65616

Ref. No. KAN-97-Q6

Dear Mr Topper:

This is in reference to [redacted] which is distributed by your firm. The product contains [redacted] as the active ingredient and the immediate container label offers the product for relief of conditions such as sinus, sinus headaches, cold and head congestion, asthma, bronchitis, laryngitis, emphysema, and chest congestion. A promotional brochure bears additional claims for the relief of cold sores, bacterial infection of the feet, carpal tunnel syndrome, and gout. These make [redacted] a drug within the meaning of Section 201(g) of the Federal Food, Drug, and Cosmetic Act (Act).

The product is subject to final regulations which cover topical OTC cough and cold preparations contained in Title 21 Code of Federal Regulations (21 CFR 343 — copy enclosed for your reference). [redacted] is not generally recognized as safe and effective (GRAS/E) for any of the indications permitted under the final rules covering the cough and cold preparations. Further, eucalyptus oil offered for relief of cold sores and fever blisters is not acceptable as a topical analgesic preparation [21 CFR 310.545(a)(10)(v)], and there is no evidence to show that eucalyptus oil is acceptable for bacterial infection of the feet, carpal tunnel syndrome, or gout. Therefore, we consider [redacted] a new drug within the meaning of Section 201(p) of the Act which may not be 1egally marketed in this country unless it has an approved New Drug Application (NDA). [redacted] is also misbranded within the meaning of Section 501(f)(1) of the Act in that its labeling fails to bear adequate directions for the labeled uses.

The above list of violations is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that the drug products you distribute are in compliance with the Act and regulations promulgated under the Act. Federal agencies are routinely advised of Warning Letters issued so that they may take this information into account when considering the award of contracts. You should take prompt action to correct these violations. Failure to correct these violations may result in regulatory action, including seizure and/or injunction, without further notice.

You should notify this office in writing within fifteen (15) working days of receipt of this letter of specific steps you have taken to correct the new drug and misbranding violations. If correction cannot be completed within fifteen working days, state the reason for the delay and the time frame within which corrections will be completed. Your reply should be directed to Clarence R. Pendleton, Compliance Officer, at the above address.

W. Michael Rogers
District Director

21 CFR 341

This page was posted on August 20, 2006.