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U.S. Department of Health and Human Services

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Enforcement Actions

Gulla, Jennifer 31-Jan-08

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900


WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

January 31, 2008

W/L 09-08

Jennifer Gulla
30262 Crown Valley Pkwy,
Suite 289
Laguna Niguel, CA 92677

Dear Ms. Gulla:

This letter concerns your firm's marketing of the product "Blow" on your website, www.iloveblow.com. According to information on your website, Blow is marketed as an alternative to an illicit street drug and is intended to affect the structure or function of the body.

The following information found on your product container or on your website demonstrates that your product is intended as an alternative to an illicit street drug:

• The name of your product, "Blow," is well known street drug terminology for illicit cocaine, and as such suggests that the product is intended to affect the structure or function of the body. In conjunction with the information below, the name "Blow" may suggest to the ordinary observer that the product may have effects on the body similar to cocaine.

• The letters in the product name appear to be spelled out in a white granular substance that resembles cocaine powder.

• The product labeling and website contain multiple images of a white granular substance that appears to be cocaine powder.

• Some of the images that appear to be cocaine powder illustrate that the powder has been "cut" by an object (presumably a credit card or a razor blade) and formed into "lines," suggestive of the practice used to divide cocaine powder into very fine particles to increase the efficiency of nasal absorption prior to insufflation, i.e., snorting, the most common method of using illicit cocaine.

• The product comes packaged in a vial suggestive of street drug paraphernalia, such as the small vials used to store "crack cocaine."

• Well-known terminology associated with and suggestive of illicit drug use is employed, such as in the names of products sold: "The Stash Box Sampler Pack," "The Recreational User Pack," and "The Fiender's Hook-Up."

• Multiple photographs and other images are used that imply illicit cocaine production, storage and transport. These include:

• a photograph illustrating bare-handed sieving of a white substance resembling cocaine powder,
• camouflaged vehicles with palates of white bales - presumably cocaine - in an unpaved, remote-looking area, and the image of a speedboat being followed under the gun of what appears to be a law enforcement officer in a helicopter, suggestive of illegal cocaine trafficking and distribution.

FDA has become aware of the proliferation of various products that are being manufactured, marketed, or distributed as alternatives to illicit street drugs (street drug alternatives): FDA is concerned that these products pose a potential threat to the public health.

Some street drug alternatives are being marketed as dietary supplements. But FDA does not believe that street drug alternatives are intended to be used to augment the diet, to promote health, or to reduce the risk of disease. Accordingly, street drug alternatives do not qualify as dietary supplements. See United States v. Undetermined Quantities of Articles of Drugs, 145 F. Supp. 2d 692 (D. Md. 2001). In March of 2000, FDA made available a guidance for industry on street drug alternatives. This document contains additional information and is available at http://www.fda.gov/cder/guidance/index.htm.

Your product, Blow, is a drug, as defined by Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because it is intended to affect the structure or any function of the body of man or other animals. Moreover, this product is a new drug, as defined by Section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses. Under Sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of Blow without an approved application violates these provisions of the Act.

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that you comply with all requirements of federal law, the Act and its implementing regulations.

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. Individuals and businesses that violate the Act may also be subject to criminal prosecution.

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 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. Additionally, if another firm manufactures the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer.

Your response should be sent to:

Pamela B. Schweikert, Director
Compliance Branch, Los Angeles District
U.S. Food and Drug Administration
19701 Fairchild, Irvine CA 92612-2506

If you have any questions about the content of this letter please contact Mr. John J. Stamp, Compliance Officer, at (949) 608-4464.

A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (BFD-240), Center for Drug Evaluation and Research., 5600 Fishers Lane, Rockville, Maryland 20857.

Sincerely,

/S/

Alonza E. Cruse
Director
Los Angeles District
U.S. Food and Drug Administration