Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
  Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

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

WARNING LETTER

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:

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:

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:

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:

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.

Sincerely,

/S/

Charles M. Breen
District Director

This page was posted on January 31, 2010.

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