Smoky Mountain Naturals, LLC

WARNING LETTER Smoky Mountain Naturals, LLC MARCS-CMS 609235 — December 02, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United Parcel Service Product: Drugs Recipient: Recipient Name Daniel Jetton Smoky Mountain Naturals, LLC 3605 Nebraska Avenue Nashville , TN 37209 United States Issuing Office: Division of Human and Animal Food Operations East V United States December 2, 2020 WARNING LETTER No.609235 Dear Mr. Jetton: This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.smnutrition.com in November 2020, and has determined that you take orders there for your products “Evening Primrose Oil,” and “Beta Glucan.” The claims on your website establish that these 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 can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov. Examples of some of the claims observed on your website that provide evidence that your products are intended for use as drugs include: “Evening Primrose Oil” Under the blog portion of your website, your article titled, “All About Evening Primrose Oil,” states the following: “Evening Primrose Oil is effective at reducing inflammation” “Evening Primrose Oil has been traditionally used for: o Psoriasis o Eczema o Inflammation-related Acne o High Blood Pressure” “Evening Primrose Oil is a great addition for those with rheumatoid arthritis, bringing considerable reduction in pain and functional impairment.” “EPO even has the impressive ability to reverse some diabetic nerve damage by improving the condition of the myelin sheath” “Beta Glucan” Under the blog portion of your website, your article titled, “5 Immune Boosting Tricks You May Not Know,” states the following: “Beta Glucan supplements taken orally can help prevent sickness and[ ] support faster recovery from viruses.” “[M]ay also[ ]reduce the severity of upper respiratory tract infections.” Your “Evening Primrose Oil,” and “Beta Glucan” 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 FD&C 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. Your “Evening Primrose Oil,” and “Beta Glucan” products 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, “Chelated Zinc Glycinate,” “Evening Primrose Oil,” and “Beta Glucan” products 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)]. 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 all products marketed by your firm comply with all requirements of federal law, including FDA regulations. You should take prompt action to correct the violations noted in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the above violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your written reply should be directed to U.S. Food and Drug Administration, Zada L. Giles, Compliance Officer, 404 BNA Drive, Suite 500, Nashville, TN 37217. If you have any questions with regard to this letter, please contact Zada L. Giles, at (615) 366-7985 or via email at ORAHAFEAST5FirmResponses@fda.hhs.gov. Sincerely, /S/ Steven B. Barber Director, Division V Office of Human and Animal Foods Operations-East Content current as of: 12/15/2020 Regulated Product(s) Drugs