Department of Health and Human Services
|Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
January 15, 2009
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 09-10
Joseph E. Todesco, President
Haelan Products, Inc.
18568 142nd Avenue Northeast
Woodinville, Washington 98072-8520
Dear Mr. Todesco:
During an inspection of your firm on September 10 and 11, 2008, an investigator from the United States Food and Drug Administration (FDA)collected your firm's label for the product Platinum Formula Haelan 951 Fermented Soy Beverage (Haelan 951). Our review of the product label noted that it lists your website at the Internet address www.haelan951.com. Although your product label and website describe Haelan 951 as a "beverage" (i.e., a conventional food) or "nutritional supplement," promotional claims on your website cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)]. You can find copies of the Act and FDA's regulations through links on FDA's website at www.fda.gov.
Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man are drugs [section 201(g)(1)(B) of the Act]. The labeling for Haelan 951 on your website bears the following claims demonstrating your product's intended use as a drug:
- "Clinical trials prove that Haelan's fermented soy beverages, when used in combination with chemotherapy and radiation, protect the cancer patient from the toxic side effects."
- "Haelan's protection from the adverse side effects of chemotherapy and radiation was excellent in a clinical study involving 318 patients (276 receiving chemotherapy and the balance radiation). Haelan's 951 reduced the toxicity of the side effects of the treatments and, in addition, none of the patients required a blood transfusion nor did anyone have to discontinue a scheduled course of treatment because of physical weakness."
- "Prior research indicates the combined use of Haelan 951 and chemothreapy [sic] will result in protected [sic] the cancer patient from the toxic effects of the chemothreapy [sic] treatments as well as increase the chemotherapy's cancer cell kill to a minimum of 8-10 times greater than is experienced from the use of chemothreapy [sic] by itself."
- "Haelan Research Foundation, Inc.... has committed to fund several clinical studies to facilitate research in te [sic] fermented soy based nutritional studies as an adjuvant to the .... current conventional based [t]reatment regimes for all types of cancers and HIV/AIDS Pilot and randomized clinical trials are being conducted to assess the impact of Haelan's fermented soy based nutritional supplementation on life extension and life enhancing threapies [sic] including, but not limited to, improvements in pain management, tumor reduction, immune functioning and quality of life."
- "We have secured an Investigational New Drug (IND) status from the FDA for formal clinical study of prostate cancer patients. Case studies of persons using Haelan 951 have been submitted for review to assess Haelan 951 merit and accepted by the National Cancer Institute (NCI) for their Best Case Series (BCS)."
- "Our research approach broadens the scope of our products, notably Haelan 951, to look at other disease states particularly chronic auto-immune disorders, degenerative diseases: cancers, heart disease, asthma, and diabetes."
- "[C]onsumption of soybeans significantly decreased chemically induced rodent mammary cancer.... Whether the soybeans were raw or cooked made no difference in the degree of inhibition of mammary cancer..."
- "Frequently Asked Questions... 4. If Haelan has many successes, why is it not more widely publicized as a cancer cure? There have been about 6,000 overall cases over the last eight years Haelan Products has been in business."
This list of claims is not intended to be all-inclusive, but represents the types of claims found on your product labeling.
These claims cause Haelan 951 to be a drug, as defined in section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. Because Haelan 951 is not generally recognized as safe and effective for the above referenced uses, the product is also a "new drug" as defined in section 201(p) of the Act [21 U.S.C. 321(p)]. Under section 505(a) of the Act [21 U.S.C. 355(a)], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Because this product is offered for conditions which 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 them safely for their intended uses. Therefore, Haelan 951 is also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for this drug fails to bear adequate directions for use [21 U.S.C. 352(f)(1)].
Even if your product Haelan 951 did not include the above claims in its labeling that cause it to be a drug, Haelan 951 would still be misbranded as a food under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] because of the following statement on your website www.haelan951.com: "Haelan 951 is approved by the Food and Drug Administration (FDA) for distribution as a nutritional supplement." This statement is false and misleading because FDA does not approve distribution of conventional foods or dietary supplements.
Further, because your product is an article used for food or drink by humans as described in section 201(f) of the Act [21 U.S.C. 321(f)] and does not meet the definition of a dietary supplement in section 201(ff) of the Act [21 U.S.C. 321(ff)], Haelan 951 is subject to regulation as a conventional food as well as a drug. Haelan 951 is not a dietary supplement for at least two reasons:
- Haelan 951 is represented as a conventional food [section 201(ff)(2)(B) of the Act] because it is characterized as a "beverage" on the product label and on your website, and because its label contains a "Nutrition Facts" panel applicable to conventional foods instead of a "Supplement Facts" panel applicable to dietary supplements. See also section 403(q)(5)(F) of the Act[21 U.S.C. 343(q)(5)(F)]; 21 CFR 101.9, 101.36.
- Haelan 951 is not labeled as a dietary supplement [section 201(ff)(2)(C) of the Act].
As a conventional food,your product is also misbranded under section 403(q) of the Act[21 U.S.C. § 343(q)] because of the following Nutrition Facts panel violations:
- Your product fails to declare trans fat in its Nutrition Facts panel as specified by 21 CFR 101.9(c)(2)(ii). Regulations requiring the declaration of trans fat went into effect on January 1, 2006 [see 21 CFR 101.9(c)(2)(ii); 68 FR 41433]. You should review all of your product labels to ensure they comply with these regulations. For additional information on trans fat labeling, go to http://www.cfsan.fda.gov/~dms/lab-cat.html#transfat.
- Your product fails to properly declare its serving size as specified by 21 CFR 101.9(b) and 101.12(b). Serving sizes are determined based on the Reference Amounts Customarily Consumed (RACC), which are set forth in 21 CFR 101.12(b). The Haelan 951 label declares the product's serving size as "4 fl oz (118ml)," but based on the RACC for "Beverages: Carbonated and noncarbonated beverages," the correct serving size is 8 fl oz (240 mL). 21 CFR 101.12(b), Table 2.
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 (15) working days of receipt of this letter, please notify this office in writing of the specific steps 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.
In addition to the above violations, we have the following comments:
- FDA reviewed other websites that include promotional claims that Haelan 951 cures," mitigates, treats, or prevents disease. Specifically, www.haelanproducts.com references Haelan 951 by name at the top of each page, includes your company's contact information, includes a printable order form for Haelan 951, includes certain text that is exactly the same as text on the www.haelan951.com website, and includes numerous promotional claims concerning use of Haelan 951 as a drug. If you own or control www.haelanproducts.com, it is your responsibility to ensure that statements on this website do not cause your product to violate the Act.
- Another website, www.haelanresearchfoundation.com, also references Haelan 951 by name and includes claims that the product cures, mitigates, treats or prevents disease. Haelan Research Foundation, Inc. and its research are also specifically referenced on your website (www.haelan951.com). The Haelan Research Foundation uses the same mailing address as your company, and you indicated to the FDA investigator that brochures stored in your facility belonged to the Haelan Research Foundation. If you own or control www.haelanresearchfoundation.com, it is your responsibility to ensure that statements on this website do not cause your product to violate the Act.
- "Your website states: "For those who cannot drink the beverage orally, Haelan 951 can be used as a retention enema." When intended for use as an enema, the product is not a conventional food or a dietary supplement because conventional foods and dietary supplements must be intended for ingestion. Promoting Haelan 951 for use as an enema subjects the product to regulation as a drug if it is intended for use either to diagnose, cure, mitigate, treat, or prevent disease [section 201(g)(1)(B) of the Act], as discussed above, or to affect the structure or function of the body [section 201(g)(1)(C) of the Act].
Your response should be sent to the Food and Drug Administration, Seattle District Office, 22201 23rd Drive SE, Bothell, Washington, 98021-4421, to the attention of Lisa M. Althar, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Althar at (425) 483-4940.
Charles M. Breen
This page was posted on January 31, 2010.