This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.younghealth.com in November 2017 and again in January 2018, and has determined that you take orders there for your Lugol's Solution 2%, Liquid Vitamin D3, Probimune, Flax Seed & Omega 3-6-9 Fish Oil, Balance Drops, Whey Protein, and Fruit of the Spirit. The claims on your website, including the new customer booklet available through your website ("The Young Health Revolution"), establish that these products are drugs under Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of these products for 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 can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.  

 

Examples of some of the claims and testimonials that provide evidence your products are intended for use as drugs include:

 

Lugol's Solution 2%

Liquid Vitamin D3

Probimune

Flax Seed & Omega 3-6-9 Fish Oil

Balance Drops

Young Health Whey Protein, Young Health Flax Seed & Omega 3-6-9 Fish Oil, Young Health Balance Drops, and Fruit of the Spirit (ingredients in your Young Health Shake)

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 Sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves new drugs 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.

 

Your Balance Drops, Whey Protein, Flax Seed & Omega 3-6-9 Fish Oil, Fruit of the Spirit, and Lugol's Solution 2% 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, Balance Drops, Whey Protein, Flax Seed & Omega 3-6-9 Fish Oil, Fruit of the Spirit, and Lugol's Solution 2%, fail to bear adequate directions for their intended use and, therefore, these 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)].

 

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 your establishment is in compliance with all requirements of federal law, including FDA regulations. 

 

You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as injunction or seizure. 

 

You should notify this office in writing within fifteen (15) business days from your receipt of this letter of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions, including an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documents. If you cannot complete all corrective actions before you respond, state the reason for your delay and the time within which you will correct the remaining deficiencies.