Denver District Office
5th Ave & Kipling St, DFC Bldg 20
P.O. Box 25087
Denver, CO 80225 

 

WARNING LETTER
 
April 6, 2018
 
VIA UPS Overnight
              
Mr. David L. Larson, CEO
Mr. Brian G. Larson, CFO
Results RNA, LLC
1272 S. 1380 W.
Orem, UT 84058
 
Ref: # HAF4W(DEN)-18-08-WL
 
Dear Mr. D. Larson and Mr. B. Larson:
 
On August 3, 2017 through August 9, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1272 S. 1380 W., Orem, Utah. During our inspection, we collected product labels for products you manufacture and distribute. Your website at the Internet address www.resultsrna.com was also reviewed. During our review of your product labels collected during the inspection, as well as our review of your firm’s website, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. 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.
 
Unapproved/Misbranded New Drugs
 
The FDA reviewed your website at the Internet address www.resultsrna.com in April 2018 and has determined that you take orders there for products, including Ultimate Lyme Support Extra Strength, ACS 200 Extra Strength, ACJ Joint Extra Strength, ACZ Nano Extra Strength, ACN Neuro Extra Strength, Allergy Care Extra Strength, MRSA Care Extra Strength, ACS 200 Silver Gel Extra Strength, ACS Nasal Extra Strength, and Lubrisine Eye Drops Extra Strength. FDA also reviewed product labels, including labels for your Ultimate Lyme Support Extra Strength, Allergy Care Extra Strength, ACS 200 Silver Gel Extra Strength, Lubrisine Eye Drops Extra Strength, ACZ Nano Extra Strength, Ultimate Body Detox Extra Strength, and Rash Care Extra Strength products following an inspection of your facility between August 3, 2017 and August 9, 2017. We have determined that the claims on your website and product labels establish that the products are drugs under section 201(g)(1)(B) of 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. 
 
Examples of some of the website and product label claims that provide evidence that your products are intended for use as drugs include:
 
Ultimate Lyme Support Extra Strength
 
Note: this is a combination product. Kit includes ACS Extra Strength, ACZ Nano Extra Strength, ACN Neuro Extra Strength and ACG Glutathione Extra Strength.
 
Website:
Product label:
ACS 200 Extra Strength
 
Website:
ACJ Joint Extra Strength
 
Website:
ACZ Nano Extra Strength
 
Website:
ACN Neuro Extra Strength
 
Website:
Allergy Care Extra Strength
 
Website:
Product label:
MRSA Care Extra Strength
 
Website:
Product label:
Ultimate Body Detox Extra Strength
 
Product label:
Rash Care Extra Strength
 
Product label:
ACS 200 Silver Gel Extra Strength
 
Website:
Product label:
ACS Nasal Extra Strength
 
Website:
Lubrisine Eye Drops Extra Strength
 
Product label:
Website:
Your 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. With respect to Lubrisine Eye Drops, OTC drug products intended as lubricant eye drops are subject to the final rule for Ophthalmic Drug Products for Over-the-Counter Use, see 21 CFR Part 349. However, this product is not labeled or formulated in accordance with this final rule because it is formulated with ingredients that are not included in this final rule. Furthermore, the final rule states that claims such as the temporary relief of burning and irritation due to dryness of the eye are permissible, however claims outside of these intended uses, such as the ones cited above, are not included in this final rule.   
 
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 Ultimate Lyme Support Extra Strength, ACN Neuro Extra Strength, ACS 200 Extra Strength, ACZ Nano Extra Strength, MRSA Care Extra Strength, ACS 200 Silver Gel Extra Strength and ACS Nasal Extra Strength 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, your Ultimate Lyme Support Extra Strength, ACN Neuro Extra Strength, ACS 200 Extra Strength, ACZ Nano Extra Strength, MRSA Care Extra Strength, ACS 200 Silver Gel Extra Strength and ACS Nasal Extra Strength products fail to bear adequate directions for their intended uses 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)].
 
Dietary Supplement Misbranding
 
Even if many of your dietary supplement products did not have therapeutic claims which make them unapproved new drugs, they would still be misbranded foods (dietary supplements) under section of 403 of the Act [21 U.S.C. § 343] in that the labels for these products do not comply with the labeling requirements in 21 CFR 101, as follows:
 
1.    Your Ultimate Body Detox Extra Strength and Ultimate Lyme Support Extra Strength products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labels fail to include a statement of identity as a “dietary supplement,” as required by 21 CFR 101.3(g).
 
2.    Your Ultimate Body Detox Extra Strength, Ultimate Lyme Support Extra Strength, ACN Neuro Extra Strength (2 oz), and ACG Glutathione (2 oz) products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling of your products do not comply with 21 CFR 101.36. For example, the Supplement Facts labels for your Ultimate Body Detox Extra Strength and Ultimate Lyme Support list (b)(2)-dietary ingredients within the proprietary blend of the ACN Neuro Extra Strength and ACG Glutathioine product; for example, zinc, magnesium, or ascorbic acid. Such ingredients may only be listed with other (b)(2)-dietary ingredients if they contain at least 2% of the RDI for the particular dietary ingredient. Likewise, the ACN Neuro Extra Strength (2 oz), and ACG Glutathione (2 oz) products, incorrectly list (b)(2)-dietary ingredients within the proprietary blend.
 
3.    Your Ultimate Body Detox Extra Strength, Ultimate Lyme Support Extra Strength, ACJ Joint Extra Strength, ACG Glutathione Extra Strength, ACG Gluco Extra Strength, ACC Cardio Extra Strength, ACN Neuro Extra Strength, ACM Metabo Extra Strength, ACP Prostate Extra Strength, ACR Regen Extra Strength, ACZ Nano Extra Strength, Allergy Care Extra Strength, ACP Pulmo Extra Strength, Rash Care Extra Strength, Pure Energy Extra Strength, MRSA Care Extra Strength, and Fem Care Extra Strength products are misbranded within the meaning of section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example, these products contain the ingredient identified as “Natural Trace Minerals” of “Natural Minerals.” This is not the appropriate common or usual name for this ingredient. The name of the mineral is the common or usual name.
 
4.    Your Ultimate Body Detox Extra Strength and Pure Energy Extra Strength products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Your Ultimate Body Detox Extra Strength product label “dosage guidelines” states to “Take 12 sprays of each by mouth, twice daily.” but your serving size for the ACZ Nano Extra Strength product component states “6 sprays.” Your Pure Energy Extra Strength product label “Directions for Use” states to “Take 12 sprays by mouth, twice daily.” but your serving size states “6 sprays.” An incorrect serving size could lead a consumer to overconsume the product.
 
5.    Your Ultimate Lyme Support Extra Strength, ACJ Joint Extra Strength, ACG Gluco Extra Strength, ACC Cardio Extra Strength, ACN Neuro Extra Strength, ACM Metabo Extra Strength, ACP Prostate Extra Strength, Allergy Care Extra Strength, MRSA Care Extra Strength, Pure Energy Extra Strength, ACP Pulmo Extra Strength, FEM Care Extra Strength and Rash Care Extra Strength products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C.  § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the products are derived, as required by 21 CFR 101.4(h)(1).
 
This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
 
We have reviewed your written responses received August-October 2017, submitted in response to the FDA Form 483, Inspectional Observations, issued to you at the close of the inspection. In general, we have no objections concerning your proposed corrective actions. You must adequately implement and maintain each corrective action to ensure its effectiveness. Your corrective actions will be assessed during a future inspection. This acknowledgement is not intended as an endorsement of current operating conditions within your firm.
 
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. If you do not believe your products are in violation of the Act, include your reasoning and any supporting information for our consideration. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
 
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented. If you need additional information or have questions, please contact the FDA. You may respond in writing to Hanna L. Potter, Compliance Officer, U.S. Food and Drug Administration, Sixth Avenue and Kipling Street, Building 20 DFC, P.O. Box 25087, Denver, CO 80255-0087. If you have any questions about the contents of this letter, please contact CO Potter at hanna.potter@fda.hhs.gov or 303-236-3094.
 
Sincerely,
/S/ 
LaTonya M. Mitchell
Denver District Director
Program Division Director
Office of Human and Animal Food –
Division IV West                                                                                                
                                                                                                           

This page was posted on May 22, 2018.

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