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Enforcement Actions

Saferex Laboratories International Corporation 04-Mar-08

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

Public Health Service
Food and Drug Administration

 

Dallas District
4040 Norht Central Expressway
Dallas, Texas 75204-3128


March 4, 2008

2008-DAL-WL-07

WARNING LETTER

VIA FEDERAL EXPRESS
RETURN RECEIPT REQUESTED

Thomas Perry
CEO/Legal Representative
Saferex Laboratories International Corporation
3218 Abbie Street
Sachse, Texas 75048

Dear Mr. Perry:

This letter concerns your firm’s marketing of the product SlicPlus on your website, www.slicplus.com. Based on promotional claims made on your website, SlicPlus is intended to mitigate, prevent, treat, or cure disease in humans. Statements on your website that document these intended uses include, but are not limited to, the following:

SlicPlus (Slic+)

• “Greatest STD Protection Without Condoms!”

• “Destroys germs that lead to viruses, infections and STD’s”

• “Natural anti-viral, anti-fungal, anti-infections, antiseptic antioxidant, anti-bacteria and germicidal properties for greatest protection.”

• “Our products give you 600% greater protection against contracting unwanted STD’s from Oral, Vaginal or Anal sexual activities. If the condom splits, tears or breaks, you still have a 600% greater resistance against contracting an STD with adding our product.”

• “The comfort in knowing there is [sic] added STD properties with sex using Slic+ makes this product number one!”

• “I would highly recommend to anyone sexually active especially with STD'S [sic] and viruses more prevalent these days.”

• “Ladies, there is a product out there that will not only help protect us from STD's but will make our sexual experiences much, much more pleasurable and much, much more safer.”

• “These products are designed to enhance personal hygiene by safely killing germs and controlling bacteria that can lead to infections, virus s [sic] and other common sexually transmitted diseases.”

• “Sexually transmitted diseases can reduce the quality of living, interfere with a normal active sex life and proven to risk life altogether. Our finished formulated product collaborates with our aim to reduce both transmission and negative fear of transmission of sexually transmitted diseases.”

• “In addition to its extraordinary cleansing and deodorizing properties, the bacteria found in human feces ranges from hepatitis to e-coli.… The properties instilled in our product create an environment in which related growing bacteria, viruses and fungi cannot live.”

• “Propyl Hydrooxybenzoate - Helps destroy nongonoccoccal urethritis - oral STD's.”

• “Citrus Racemosa - Demonstrated to be affective against over eight-hundred different types of viruses, bacteria, yeast and fungi and is a potent weapon in disease prevention and treatment. Physicians have tested and observed that the herpes simplex virus becomes inactive just minutes after application.”

• “Melaleuca Alternifolia - another extremely powerful natural ingredient that carries great anti-viral, anti-fungal and antibacterial properties. It is successfully used to treat a wide range of skin disorders, infections, from herpes to vaginal yeast infections.”

• “Thymus Vulgaris - Its antibacterial properties have tested to act on bacterial enzymes and eliminates staphylococcus.”

• “Rosa Damascena - properties that include anti-infectious, antiseptic, astringent, bacteroidal [sic] . . . .”

SlicPlus 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 for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Namely, SlicPlus is intended to cure, mitigate, treat, or prevent a variety of sexually transmitted diseases (STDs). 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 use under the conditions prescribed, recommended or suggested in its labeling. 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 SlicPlus without an approved application violates these provisions of the Act.

Furthermore, because this product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use it safely for its intended uses. Thus, SlicPlus’ labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).

Additionally, you make false and misleading promotional statements on your website regarding the product. For example, your website states, “Our laboratory tested, special formulated, all FDA approved, personal lubricants moisturize skin tissues while safely adding protection by controlling harmful bacteria s [sic] and promoting healthy bacteria s [sic].” However, your product is not the subject of an FDA-approved application. Furthermore, you state, “Our products would not be possible without the contributions and special interest from, staff and contractors of STD prevention and development, Department of Health and Human Services, Brentag Chemical Engineering, Dole Chemicals, Rain Shadow Labs, Saferex Laboratories, Center for Disease Control, National Center for HIV, STD and TB Prevention, which continues with ongoing research, development and testing to bring the very best, most up-to-date, advanced product available to the market today.” This claim misleads consumers to believe that these entities, including government agencies, support your product and its associated claims. Thus, your product is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a).

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 your firm complies with all requirements of federal law and FDA 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.

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. If you no longer manufacture or market SlicPlus, your response should so indicate, including the reasons that, and the date on which, you ceased production. 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.

Please direct your response to the U.S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300, HFR-SW140, Dallas, TX 75204, Attention: Edwin Ramos, Compliance Officer.

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 (HFD 240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.


Sincerely,

/S/

Reynaldo R. Rodriguez, Jr.
Director
Dallas District
U.S. Food and Drug Administration

cc:

Gay Dodson
Executive Director/Secretary
Texas State Board of Pharmacy
333 Guadalupe, Tower 3, Suite 600
Austin, TX 78701-3942