Recipient NameTroy A. Aupperle
Recipient TitleOwner and CEO
- Enzymology Research Center, Inc.
332 West Street N.
Miltona, MN 56354-8256
- Issuing Office:
- Office of Human and Animal Foods - West Division 1
March 26, 2020
Refer to CMS 604613
Dear Mr. Aupperle:
This is to advise you that the Food and Drug Administration (FDA) reviewed the product labels for (b)(4) and (b)(4), which you contract manufacture, following an inspection of your facility at 332 West Street N, Miltona, Minnesota, conducted between January 7 and January 9, 2020. The claims on the product labels establish that the products are drugs under section 201 (g)(1 )(B) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. 321 (g)(1)(B)], because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
You may find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
We acknowledge receipt of your response to the form FDA-483, lnspectional Observations, dated January 23, 2020, and we address your response below.
Examples of some of the claims on the product labels that provide evidence that the products are intended for use as drugs include:
(b)(4), and (b)(4) products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 201(p) of the Act (21 U.S.C. 321 (p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331 (d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act (21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
The products (b)(4) and (b)(4) are intended for treatment of one or more diseases that are not amenable to self diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, (b)(4) and (b)(4) fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act (21 U.S.C. 331(a)].
We have reviewed your written response dated January 23, 2020, which states that you plan to "[u]se up existing Labels and make changes on next run" for the (b)(4) and (b)(4) products. This response is inadequate because the existing product labels include claims that provide evidence that the (b)(4) and (b)(4) products are intended for use as drugs. Introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. For the (b)(4) product, you state that you will "[d]estroy Labels & revise new." We are unable to evaluate the adequacy of your revisions because you did not provide documentation of the revised labels.
The 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 ensure that you comply with all requirements of federal law and FDA regulations.
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.
Please respond to this office in writing within 15 working days of receiving this letter. In your response, identify the specific steps you have taken or will take to correct the violations and prevent their recurrence. Include the time frame in which the corrections will be completed and provide documentation that will effectively assist us in evaluating whether adequate corrections have been made. If you cannot complete corrective actions within 15 working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to Boun M. Xiong, Compliance Officer, at the address in the letterhead. If you have any questions about this letter, please contact Mr. Xiong at (414) 326-3976.
Michael Dutcher, DVm
Director, West Division 1
Office of Human and Animal Food Operations