Inspections, Compliance, Enforcement, and Criminal Investigations
HSAC Enterprises, Inc. dba Kare-N-Herbs 8/2/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
Phone: (781) 587-7500FAX: (781) 587-7556
August 2, 2012
Richard J. DeSoto, President
HSAC Enterprises, Inc.
26 Brickyard Court, Unit #8
York, Maine 03909
Dear Mr. DeSoto:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your firm located at 26 Brickyard Court, Unit #8, York, Maine, on March 26 to May 1, 2012. In addition, we reviewed your website at the internet address www.karenherbs.com in August 2012. The review of your product labeling, including claims on your website, revealed that your products Kold Kare, Energy Kare, and Tranquility Kare are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims in your product labeling 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 FDA regulations through links on FDA’s home page at www.fda.gov.
Specific examples of claims in your product labeling that promote such products as drugs are as follows:
- “Cold & Flu, Sinusitis”
- “Kold Kare is deemed effective in reducing headache pain, fever, irritation, congestion & general fatigue, quickly and naturally.”
- “Prevents Colds & Flu”
- “Relieves Sinus Pain”
Your web site also contains disease claims in the form of personal testimonials about your Kold Kare product, including:
- “I have tried just about everything for my sinus headaches, and nothing works, Since getting Kold Kare, I have had two bouts with a sinus headache, and Kold Kare actually did the trick ”
- “Improves sexual performance”
- “A recent scientific study has shown that this herb successfully treats sexual disorder in men”
- “Rhodiola Rosea [an ingredient in your product] . . .has now been clinically proven to … successfully treat sexual disorders in men ranging from weak erections to premature ejaculation. Clinical studies on patients suffering sexual impotency, weak erections, premature ejaculations … showed significant improvement in sexual functions, including a normalization of prostate gland fluids … when using Rhodiola Rosea”
Your web site also contains disease claims in the form of personal testimonials about your Energy Kare product, including:
- “I have fibromyalgia, which causes me extreme fatigue. Rhodiola [an ingredient in your product] improves the overall quality of my life”
- “TRANQUILITY KARE has been known to reduce … insomnia. Also reduces Inflammation at joints.”
In addition, these products are not generally recognized as safe and effective for the above referenced conditions for which each is promoted and, therefore, these products are also new drugs under Section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]. 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 U.S.C. § 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.
Further, your Energy Kare and Tranquility Kare products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your Energy Kare and Tranquility Kare products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)], in that the labeling for these drugs fails to bear adequate directions for use.
A written response was received on May 15, 2012. Your response indicated that “medical claims and unsubstantiated claims” would be removed from your websites within 60 days; however, we note that as of August 1, 2012 the claims had not been removed. Further your response regarding your hardcopy product labeling is inadequate, as you state your intention is to exhaust existing inventory over the next 12 -18 months.
This letter is not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to do so may result in enforcement action without further notice, including, but not limited to, seizure and/or injunction of violative products.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Bruce R. Ota, Compliance Officer, at the above address. If you have questions regarding any issues in this letter, please contact Mr. Ota at 781-587-7487
Mutahar S. Shamsi
New England District