Source: https://www.casewatch.net/fdawarning/prod/2013/health_king.shtml
Timestamp: 2019-04-26 01:59:21+00:00

Document:
Health King Enterprise & Balanceuticals Group, Inc.
This is to advise you that the U.S. Food and Drug Administration (FDA) has reviewed your websites, www.healthkingenterprise.com and www.balanceuticals.com, which redirects to www.healthkingenterprise.com, in June 2013 and has determined that you take orders there for your products, “Sugar Balancer”, “Blood Pressure Balance”, Bio-Defender”, “AlcohLiver Fix” and “Super Reishi Essence,” which the websites promote for conditions that cause the products to be drugs under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The claims on your website establish that the products are drugs 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.
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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 Section 505(a) of the Act [21 U.S.C. § 355(a)], see also Section 301(d) of the Act [21 U.S.C. § 331(a)]. 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.
Furthermore, your products, “Sugar Balancer”, “Blood Pressure Balance”, Bio-Defender”, “AlcohLiver Fix” and “Super Reishi Essence,” are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your products are misbranded within the meaning of Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of Section 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and state the date by which the corrections will be completed.
Your firm’s response should be sent to: Carrie Ann Plucinski, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS case # 391124) when replying. If you have any questions about the content of this letter, please contact Ms. Plucinski at 312-596-4224.
This page was posted on August 14, 2017.

References: § 321
 § 321
 § 355
 § 331
 § 352
 § 331