Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm418714.htm
Timestamp: 2019-04-21 23:01:43+00:00

Document:
This is to advise you that in June 2013 and September 2014 the U.S. Food and Drug Administration (FDA or we) reviewed your website at www.bethel30.com and has determined that you take orders there for the products 15 Day Detox Diet, Alpha Lipoic Acid. 300 mg. Capsules, Black Cohosh, B Thinner, Carbo-Fat, Cascara sagrada, Cholest Away, Dong Quai, Eagle Eye, Garlic and Parsley, Ginseng Extract, Lecithin, Omega Max EPA, Potassium, Saw Palmetto, St. John’s Wort, Sweet Sleep, Ultimate B Burner, Valerian Root, Women Plus, and Yohimbe, which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic 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 FD&C Act. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Your 15 Day Detox Diet, Alpha Lipoic Acid. 300 mg. Capsules, Black Cohosh, B Thinner, Carbo-Fat, Cascara sagrada, Cholest Away, Dong Quai, Eagle Eye, Garlic and Parsley, Ginseng Extract, Lecithin, Omega Max EPA, Potassium, Saw Palmetto, St. John’s Wort, Sweet Sleep, Ultimate B Burner, Valerian Root, Women Plus, and Yohimbe are not generally recognized as safe and effective for the above referenced uses and therefore, the products are “new drugs” under section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]. Under sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of these products without such approved applications violates these provisions of the Act.
These products are prescription drugs as defined in section 503(b)(1)(A) of the Act (21 U.S.C. § 353(b)(1)(A)) because, in light of their toxicity or other potentiality for harmful effect, the method of their use, or the collateral measures necessary to their use, the products are not safe for use except under the supervision of a practitioner licensed by law to administer them.
According to section 502(f)(1) of the Act (21 U.S.C. § 352(f)(1)), a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layman can use a drug safely, and for the purposes for which it’s intended (21 CFR § 201.5). Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner. Therefore it is impossible to write “adequate directions for use” for prescription drugs. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson (21 CFR § § 201.100(c)(2) and 201.115). Because there is no FDA-approved application for your products, its labeling fails to bear adequate directions for its intended use, causing it to be 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 products violates section 301(a) of the Act (21 U.S.C. § 331(a)).
Although some of the claims described in this section were discussed with your firm in June 2013, no corrective action was noted when we reviewed your website again in September 2014.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations noted above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. In particular, to the extent you manufacture, package, label, or hold dietary supplements, you are subject to all applicable requirements in 21 CFR part 111 relating to your operations for the manufacture, packaging, labeling, and holding of dietary supplements.
You should take prompt action to correct all of 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.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that 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 your delay and the time within which you will complete the correction.
If you have any questions about the content of this letter please contact: Compliance Officer Aveta at (718) 662-5576.

References: § 321
 § 321
 § 353
 § 352
 § 201
 § 201
 § 352
 § 331