Complaint Review: Visiontel Communications - (dba Vision Labs) - Nationwide

In reference to Epiclear and Vision Labs complaints and comments. My friend was ripped off by the company and brought it to my attention. While trying to get her money back I did some research on Vision Labs. I found the warning letter on the following web page; FOI Homepage | Warning Letters FDA Home Page | Search | A-Z Index | Site Map | Contact FDA FDA/Web site Management Staff Web page created by god 7/19/02 AS OF 11/27/2004 NO RESPONSE ON FILE to the warning letter. Department of Health and Human Services Public Health Service Food and Drug Administration New England District One Montvale Avenue Stoneham, Massachusetts 02180 (781) 596-7700 FAX (781) 596-7896 WARNING LETTER NWE-19-02W June 24, 2002 VIA FEDEX Michael J. McNaboe, President Vision Laboratories DBA VisionTel Communications LLC 51 Dow Highway, Suite 11 Eliot, Maine 03903 Dear Mr. McNaboe: This letter is written in reference to the marketing of "Epiclear Liposomal Facial Remedy" by your firm. The product labeling and promotional literature indicate that the product is for over-the-counter (OTC) treatment of acne. According to labeling and promotional literature, the product contains water, glycerol, phosphatidylcholine from natural lecithin, vitamin C, ethanol, vitamin E-acetate, menthol, vitamin A-palmitate, and chlorhexidine-salt as ingredients. Your "Epiclear Liposomal Facial Remedy" package insert "INSTRUCTIONS FOR USE" states "For the first 3 days, spray epiclear onto affected area 4 to 5 times a day (use 8 times a day if you have large, red pimples), and rub liquid gently into skin with fingertips." Also, the package insert states "Continue using epiclear twice a day, every other day until blemishes have disappeared and skin has healed." Other promotional literature entitled "Epiclear Amazing new all-natural formula" for your product states "Do you suffer with acne or other skin irritations.. .I and "Unique and highly effective, epiclear is specially designed to penetrate deeply into your pores, unclogging and killing the bacteria that cause pimples, blackheads, whiteheads, and patches of redness." Based on the intended uses established by the claims cited above, the product is a drug as defined in Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act). As labeled and promoted "Epiclear Liposomal Facial Remedy" is subject to the acne final regulations found in 21 CFR 333.301, 333.310, 333.320, and 333.350. Although the active ingredients in this product are not specifically identified on the product label, labeling distributed with the product promote the ingredients in the formula for acne treatment. None of these ingredients are permitted as active ingredients under the regulations for OTC acne products. Because the labeling and formulation of "Epiclear Liposomal Facial Remedy" do not comply with the final regulations, your product is a "new drug" (Section 201 (p) of the Act) which may not be legally marketed in the United States without an approved New Drug Application (Section 505). The product is misbranded (Sections 502(f)(l) and 502(f)(2) of the Act) for failure to comply with the final regulations covering topical acne products under 21 CFR Parts 333.301 with respect to directions- for use and required warnings. You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Possible actions include seizure and/or injunction. Please notify this office in writing within fifteen (15) working days of receipt of this letter and the specific steps you have taken to correct the violations described above. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be implemented. You should direct your reply to Bruce R. Ota, Compliance Officer, at the address noted above. If you have any questions concerning this matter, please contact Mr. Ota at 781-596-7762. Sincerely, /s/ Gail T. Costello District Director New England District Office

Fran is a little misunderstood. The notice from the FDA regarding EpiClear was fromquite a while ago. Shortly after that was sent to the company, EpiClear was taken off the market. Otherwise, the company would have been shut down. There were a few ingredients in it that were safe but had recently been declassified by the FDA from an herbal product to a drug. The company that sells EpiClear sells only herbal, all natural products and market them that way so the ads had the be taken off the air. A few months later (and quite a few dollars later I may add), Visiontel had the formula for EpiClear revamped to meet the FDA and Visiontel standards of all natural. After the getting the OK to resell it, they began the campaign that they are promoting now. In regards to making a ton on shipping, the charge is only $9.95 or $14.95 if you want Priority mailing. The product normally runs $60 and is sent for free (incl. s+h). Although the promotion is set up to send more product to those who want it, they are given a 3 week trial to cancel if they decide they dont. Having worked with the company for a while, I can state that no "Scams" as Fran would say are being formulated or used by the company. Please learn the truths before posting negative information. Legal types may call it slander, I call it naive.

Fran is a little misunderstood. The notice from the FDA regarding EpiClear was fromquite a while ago. Shortly after that was sent to the company, EpiClear was taken off the market. Otherwise, the company would have been shut down. There were a few ingredients in it that were safe but had recently been declassified by the FDA from an herbal product to a drug. The company that sells EpiClear sells only herbal, all natural products and market them that way so the ads had the be taken off the air. A few months later (and quite a few dollars later I may add), Visiontel had the formula for EpiClear revamped to meet the FDA and Visiontel standards of all natural. After the getting the OK to resell it, they began the campaign that they are promoting now. In regards to making a ton on shipping, the charge is only $9.95 or $14.95 if you want Priority mailing. The product normally runs $60 and is sent for free (incl. s+h). Although the promotion is set up to send more product to those who want it, they are given a 3 week trial to cancel if they decide they dont. Having worked with the company for a while, I can state that no "Scams" as Fran would say are being formulated or used by the company. Please learn the truths before posting negative information. Legal types may call it slander, I call it naive.

Fran is a little misunderstood. The notice from the FDA regarding EpiClear was fromquite a while ago. Shortly after that was sent to the company, EpiClear was taken off the market. Otherwise, the company would have been shut down. There were a few ingredients in it that were safe but had recently been declassified by the FDA from an herbal product to a drug. The company that sells EpiClear sells only herbal, all natural products and market them that way so the ads had the be taken off the air. A few months later (and quite a few dollars later I may add), Visiontel had the formula for EpiClear revamped to meet the FDA and Visiontel standards of all natural. After the getting the OK to resell it, they began the campaign that they are promoting now. In regards to making a ton on shipping, the charge is only $9.95 or $14.95 if you want Priority mailing. The product normally runs $60 and is sent for free (incl. s+h). Although the promotion is set up to send more product to those who want it, they are given a 3 week trial to cancel if they decide they dont. Having worked with the company for a while, I can state that no "Scams" as Fran would say are being formulated or used by the company. Please learn the truths before posting negative information. Legal types may call it slander, I call it naive.

Fran is a little misunderstood. The notice from the FDA regarding EpiClear was fromquite a while ago. Shortly after that was sent to the company, EpiClear was taken off the market. Otherwise, the company would have been shut down. There were a few ingredients in it that were safe but had recently been declassified by the FDA from an herbal product to a drug. The company that sells EpiClear sells only herbal, all natural products and market them that way so the ads had the be taken off the air. A few months later (and quite a few dollars later I may add), Visiontel had the formula for EpiClear revamped to meet the FDA and Visiontel standards of all natural. After the getting the OK to resell it, they began the campaign that they are promoting now. In regards to making a ton on shipping, the charge is only $9.95 or $14.95 if you want Priority mailing. The product normally runs $60 and is sent for free (incl. s+h). Although the promotion is set up to send more product to those who want it, they are given a 3 week trial to cancel if they decide they dont. Having worked with the company for a while, I can state that no "Scams" as Fran would say are being formulated or used by the company. Please learn the truths before posting negative information. Legal types may call it slander, I call it naive.