Inspections, Compliance, Enforcement, and Criminal Investigations
B & A Health Products Inc 8/19/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2506
RETURN RECEIPT REQUESTED
August 19, 2010
Sam Ahn, CEO
B&A Health Products Inc.
12065 Clark Street
Santa Fe Springs, CA 90670
Dear Mr. Ahn:
This letter is in reference to the over-the-counter (OTC) liquid drug product Pancold A distributed by your firm. According to the package labeling for this product, Pancold A is intended for use as a pain reliever-fever reducer, antihistamine, sputum suppressant, sneeze suppressant, and nasal decongestant. Based upon these claims, Pancold A is a drug under section 201(g)(1)(B) of the Act (21 U.S.C. § 321(g)(1)(B)), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, and under section 201(g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)(C)), because it is intended to affect the structure or function of the body.
In order for OTC cold, cough, allergy, bronchodilator, and antiasthmatic drug products to be generally recognized as safe and effective and not misbranded, and thus be marketed without an approved NDA, they must meet the requirements of the final monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC use, 21 CFR Part 341. Pancold A is an unapproved new drug because it does not meet this final monograph. Specifically, the product contains active ingredients that do not comply with the final monograph, such as anhydrous caffeine and di-methylephedrine hydrochloride. Additionally, the product contains indications that do not comply with the final monograph, such as sputum suppressant and sneeze suppressant.
As formulated and labeled, Pancold A is not generally recognized as safe and effective for the indications described in its labeling, and it is, therefore, a new drug under section 201(p) of the Act (21 U.S.C. § 321 (p)). Under section 505(a) of the Act (21 U.S.C. § 355(a)), a new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA-approved application. As the distributor of this product, your firm's marketing of Pancold A without an FDA-approved application violates this provision of the Act..
In addition to the above violation, Pancold A is not labeled in accordance with the "Drug Facts" labeling requirements described in 21 C.F.R. § 201.66. Therefore, this product also misbranded under section 502(c) of the Act (21 U.S.C. § 352(c)), because the information that is required to appear on the labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
The violations cited in this letter are not an all-inclusive list of products or deficiencies. You are responsible for investigating and determining the causes of these violations and for preventing their recurrence and the occurrence of other violations. Your firm distributes other products. Some of these products may also be unapproved drug products. You should ensure that the distribution of such products does not violate the provisions of the Federal Food, Drug and Cosmetic Act.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the referenced violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your reply should be addressed to:
U.S. Food and Drug Administration
Attn: Dan Solis
Director, Imports Operations Branch
Los Angeles District
222 W. 6th Street, Suite 700
San Pedro, CA 90731
If you have any questions about the content of this letter please contact Deborah Parks, Compliance Officer, at 310-971-2312.
Alonza E. Cruse
Los Angeles District Director
CC: Dongwha Pharm. Ind. Co., Ltd.
5 Soonwha-dong, Joong-gu
Cc: Branch Director
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413