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

Public Health Service
Food and Drug Administration
Philadelphia District

 

900 US Customhouse
2nd & Chestnut Sts
Philadelphia, PA 19106
Telephone: 215-597-4390

October 5, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Ronald G. Betz, President & CEO
Penn Herb Co, Ltd
10641 Decatur Rd
Philadelphia, PA 19154

Ref. No. PHI-06-01

Dear Dear Mr Betz:

On June 23, 2005, an investigator from the Food and Drug Administration (FDA) concluded an inspection of your herbal and dietary supplement manufacturing, repacking, and distribution facility located at 10601 Decatur Rd, Philadelphia, PA. During this inspection, you provided our investigator with labeling, including various labels and product catalogs. FDA has reviewed your labeling, including your websites at www.pennherb.com, for your products Gluco-Ease Plus™ (formerly Diab-Ease Plus™), Joint Ease™ (formerly Arth-Ease™), Prostaid Plus™, Soothing Bowel Support™ (formerly Irritable Bowel Support™), Golden Seal and Myrrh™, and Colostrum and found that they are promoted for conditions that cause them to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)]. The therapeutic claims on your websites establish that these products are drugs because they are intended for use in the cure, mitigation; treatment, or prevention of disease. The marketing of these products with these claims violates the Act. You can find the Act and implementing regulations on FDA's website at www.fda.gov.

Specific examples of disease claims as defined under 21 CFR 101.93(g) in your product labeling are as follows:

Furthermore, FDA has no information that your products are safe and effective for the above referenced conditions and, therefore, these products are also new drugs under section 201(p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 USC 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. In addition, your products are misbranded under Section 502(f)(1) of the Act in that they fail to bear adequate directions for use.

This letter is not intended to be an all-inclusive review of the labeling and products your firm may market. You should review the labels for all of your products to ensure that they comply with the applicable requirements of the Act and implementing regulations. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.

Please notify this office in writing within fifteen (15) days of receipt of this letter as to the specific actions you have taken or intend to take to correct these violations, including any steps taken with respect to product currently in the marketplace, and, an explanation of each step taken to assure that similar violations do not recur. If corrective action cannot be completed within fifteen days, please include in your reply the reason for the delay, the time within which the corrections will be completed, and any documentation necessary to indicate correction has been achieved.

Your reply should be directed to William J. Forman, Compliance Officer, at the above address.

Sincerely,
/s/
Thomas D. Gardine
Division Director

This page was posted on March 28, 2006.

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