Inspections, Compliance, Enforcement, and Criminal Investigations
Good, Cheryl 12-Jul-06
Department of Health and Human Services
Public Health Service
New Orleans District
July 12, 2006
WARNING LETTER NO. 2006-NOL-12
Ms. Cheryl Good
212 Foster Landing Road
Guntersville, AL 35976
Dear Ms. Good:
This letter concerns your firm's marketing of the products RAE'lex Circulation Formula, RAE'lex Wound Gel, and RAE'lex Lotion on your website, www.raelex.net. As reviewed on March 31, 2006, according to the claims and information on your website, these products are intended for topical use to prevent, treat, or cure disease conditions or to affect the structure or function of the body. The statements on your website documenting these intended uses include, but are not limited to, the following:
RAE'lex Circulation Formula
"Do you have painful, numb, or burning feet from diabetic neuropathy? Try the soothing relief of RAE'lex Circulation Formula"
"For swelling of lower legs, improved circulation, relief of pain symptoms of diabetic neuropathy and for smaller surface diabetic related wounds we recommend RAE'lex Circulation Formula."
"Helps to relief [sic] pain symptoms of diabetic neuropathy."
"After dealing with the bedsore for five months with no success, the doctor said the only alternative was to amputate [my mother's] foot. I ordered the circulation formula and the doctor, wound care specialist and home health care [sic] are amazed at the good results that we have had with the product'. [sic] Note: Mrs. Kirkland's mother's foot was not amputated."
"She suffered a minor injury to the leg that would not heal. The wound continued for over a year. . . . She began using the circulation formula every day on her leg, and after one month, we were amazed to see the redness and the swelling that had been there for years was gone completely."
RAE'lex Wound Gel
"RAE' lex Wound Gel used for diabetic ulcers . . . ."
"Used for non-healing wounds of all stages."
"For diabetic preventive §kin care use RAE'lex Lotion"
"Use for diabetic preventive skin care . . . ."
These claims are supplemented by the metatags you use to bring consumers to your website, www.raelex.net. These metatags include "Diabetic Foot Ulcers," "Relief of pain symptoms of diabetic neuropathy," and "Improved circulation."
Your products, RAE'lex Circulation Formula, R.AE'Iex Wound Gel, and RAE'lex Lotion, are drugs, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) § 321(g)(1)(B) and (C)] , because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or to affect the structure or any function of the body of man. Moreover, these products are new drugs, as defined by section 201(p) of the Act [21 USC § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. Under sections 301(d) and 505(a) of the Act [21 USC §§ 331(d) and 355(a)], the introduction or delivery of a new drug into interstate commerce without a U. S. Food and Drug Administration (FDA) approved application is a prohibited act. No such applications exist for these products. Accordingly, your sale of RAE'lex Circulation Formula, RAE'lex Wound Gel, and RAE'lex Lotion without approved applications violates these provisions of the Act.
Furthermore, because the above-mentioned products are offered for diseases or conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so a layman can use these products safely for their intended uses. Thus, because the labeling for RAE'lex Circulation Formula, RAE'lex Wound Gel, and RAE'lex Lotion fails to bear adequate directions for the products' intended uses for diseases or conditions, which are not amenable . to self-diagnosis and treatment, they are misbranded under section 502(f)(1) of the Act [21 USC § 352(f)(1)].
The above violations are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure the drug products you manufacture or distribute, meet all the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so they may take this information into account when considering the award of contracts.
You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action without further notice. The Act provides for the seizure of illegal products and for an injunction against the manufacturer and distributors of illegal products.
You must notify this office in writing within fifteen (15) working days of receipt of this letter as to the steps you have taken to correct the above-listed violations and to assure similar violations will not recur. You should include with your response any documentation necessary to show the corrections have been achieved: If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Additionally, if your firm does,not manufacture the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier, in addition to the manufacturer. Address your reply to the U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001, Attention: Rebecca A. Asente, 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 FDA, Division of Drug Information, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
H. Tyler Thornburg
New Orleans District