Inspections, Compliance, Enforcement, and Criminal Investigations
Healthworks 2000 30-Nov-05
Department of Health and Human Services
Public Health Service
November 30, 2005
21107 Rio Sabinal
San Antonio, TX 78259
The Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www.healthworks2000.com and has concluded that claims in the labeling for your product ZymePro Plus™ w/Serrapeplase to be a drug as defined in 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 the Act and FDA's regulations through links on FDA's Internet homepage: http://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, 21 U.S.C. 321 (g)(1)(B)]. Your website claims that your product is useful in the prevention and treatment of avian flu and other forms of influenza.
The Internet labeling of your products bear the following claims under the banner "Lean about Avian Influenza (Bird Flu)":
All Natural Alternative That Helps Fight Viruses
Healthworks 200 Recommendation
Systemic Enzyme Therapy [link to information and online ordering for your product ZymePro Plus™ w/Serrapeplase]
How Enzymes Helps (sic) Fight Viruses
Enzymes in the Systemic Enzymes can eat away at the virus protein shell making it easier for your immune system to battle the virus.
Improve anti-virals kills the virus
Lowers viral loading
CLICK HEHE To Learn How Systemic Enzymes Helps Fight Viruses [link to information and online ordering for your product ZymePro Plus™ w/Serrapeplase]
What is avian influenza (bird flu)?
bird flu is an infection caused by...viruses."
The Internet labeling of your product on your web site bears the following claims on a web page providing information and online ordering for your product ZymePro Plus™w/Serrapeplase:
"How Can Enzymes Assist in fighting the Flu Virus " [link to the claims on your web site under the banner "Learn About Avian Influenza (bird Flu) cited above]
These claims cause your product to be a drug, as defined in section 201(g)(1)(B) of the Act [21 U.S.C. 321 (g)(1)(B)]. Because your product is not generally recognized as safe and effective when used as labeled, it is also a new drug as defined in section 201(p) of the Act [21 U.S.C. 321(p)]. Under section 505 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). This drug is also misbranded within the meaning of section 502(a) of the Act [21 U.S.C. 352(a)] because their labeling is false and misleading in that it suggests that this drug is effective for the prevention and treatment of avian flu and other forms of influenza when, in fact, these claims are not supported by competent and reliable scientific evidence.
This letter an all-inclusive review of your website and the products that your form markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action without notice. The Act provides for seizure of illegal products and for injunctions against the manufacturers and distributors of illegal products [21 U.S.C. 332 and 334]. Individuals and businesses that violate the Act may also be subject to criminal prosecution.
Please advise this office, in writing and within fifteen (15) working days of the receipt of this letter, as to the specific steps you haven taken to correct the violations noted above and to ensure that similar violations do not occur. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your reply should be addressed to Compliance Officer Edwin Ramos at the above address. If you have questions about the contents of this letter, please contact Mr. Ramos at 214-253-5218.
Michael A. Chappell
Dallas District Director