Inspections, Compliance, Enforcement, and Criminal Investigations
Omega Supply 17-Sep-08
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
September 17, 2008
Erick Del Rio
129 Alverson Rd, Apt 3
San Ysidro, CA 92173-2464
Dear Mr. Del Rio:
This letter concerns your firm's marketing of Amygdalin/Laetril (sic) tablets, Amygdalin/Laetril inyectable (sic) solution, Cyprenil/Selegiline, Hydrazine Sulphate capsules, Clodromax (Clodronate Disodium) capsules, and Cloracesium/Cesium Chloride capsules on your website, www.laetrilesupply.com. According to information on this website, your products are intended to prevent, treat, or cure disease conditions in humans and, therefore, are considered drugs as defined by Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ("FDCA" or "the Act"), 21 U.S.C. § 321(g)(1).
Your firm makes general, all-inclusive statements about the intended use of the aforementioned products on the front page of your website. These statements include, but are not limited to, the following:
• "ALTERNATIVE MEDICINE FOR CANCER THERAPY"
• "Omega Supply is a company that offers professional service focused on the patient and their cure needs. We also offer unique and exclusive innovative medicine and treatments to fight cancer and other diseases."
These claims are supplemented by metatags used to bring consumers to your website through Internet searches. The metatags from your website include "cancer."
In addition to the disease claims cited above, you list the ingredient "laetrile" on the labeling of a number of your products, including Amygdalin/Laetril (sic) tablets and Amygdalin/Laetril inyectable (sic) solution. If a product claims to have an ingredient that has been regulated by the Food and Drug Administration (FDA) as a drug and is well known to consumers for its use or claimed use in preventing or treating a disease, the ingredient listing will be construed as a disease claim and the product will be considered a drug under the Act. See, e.g., 21 C.F.R. 101.93(g)(2)(iv)(B). FDA has long considered and regulated laetrile as a drug, see, e.g., United States v. Rutherford, 99 S. Ct. 2470 (1979), and laetrile's claimed use as a cancer treatment is widely known by consumers. As such, listing the ingredient "laetrile" on the labeling causes your products Amygdalin/Laetril (sic) tablets and Amygdalin/Laetril inyectable (sic) solution to be drugs under section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1).
For these reasons, Amygdalin/Laetril (sic) tablets, Amygdalin/Laetril inyectable (sic) solution, Cyprenil/Selegiline, Hydrazine Sulphate capsules, Clodromax (Clodronate Disodium) capsules, and Cloracesium/Cesium Chloride capsules are drugs, as defined by section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. Moreover, these products are new drugs, as defined by section 201(p) of the Act, 21 U.S.C. § 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 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 the aforementioned products without approved applications violates these provisions of the Act.
Furthermore, since Amygdalin/Laetril (sic) tablets, Amygdalin/Laetril inyectable (sic) solution, Cyprenil/Selegiline, Hydrazine Sulphate capsules, Clodromax (Clodronate Disodium) capsules and Cloracesium/Cesium Chloride capsules are offered for conditions such as cancer 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 the products safely for their intended uses. Thus, your products' labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). These drugs are not exempt from this requirement under 21 C.F.R. § 201.115 because they are new drugs within the meaning of section 201(p) of the FDCA, 21 U.S.C. § 321(p), and they lack approved applications filed pursuant to section 505 of the FDCA, 21 U.S.C. § 355.
We note that you have attempted to disclaim some of the statements on your site that indicate that the products are intended to prevent, treat, or cure disease conditions. For example, your website states:
"Statements made on this website have not been evaluated by the Food and Drug Administration. Products are not intended to diagnose, treat, cure or prevent any disease. Remember, Omega Supply makes no claims or promises as to health benefits of its health supplements. All research information is provided as courtesy to customers."
This disclaimer does not change your products' status as drugs. Untrue or misleading information in one part of your site will not be mitigated by inclusion of such a "disclaimer." Cf. 21 C.F.R. 202.1(e)(3)(i).
Additionally, based on the graphic representations included on your website for some of your products, it appears that several of the products, including Amygdalin/Laetril (sic) tablets and Amygdalin/Laetrile inyectable (sic) solution, are labeled solely in Spanish. In fact, Amygdalin/Laetril (sic) tablets and Amygdalin/Laetrile inyectable (sic) solution purchased from your website were labeled solely in Spanish. However, your products are not permitted to bear the required information solely in Spanish because the products are not distributed exclusively in the Commonwealth of Puerto Rico or in a U.S. Territory where the predominant language is Spanish. 21 C.F.R. § 201.15(c). Therefore, these products are misbranded under section 502(c) of the Act, 21 U.S.C. § 352(c).
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 products. 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. We advise you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
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. Please direct your response to the U.S. Food and Drug Administration, 19701 Fairchild, Irving, CA 92612, Attention: MaryLynn Datoc, Compliance Officer. 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 the aforementioned products, your response should so indicate, including the reasons that, and the date on which, you ceased production. Additionally, if another firm manufactures 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.
Alonza E. Cruse
Director, Los Angeles District
Erick Del Rio
PO Box 435079
San Ysidro, CA 92173