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WARNING LETTER

Osmosis, LLC MARCS-CMS 652059 —

Delivery Method:
VIA UPS and Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Dr. Benjamin T. Johnson, MD
Recipient Title
CEO
Osmosis, LLC

30746 Bryant Dr, Unit 410
Evergreen, CO 80439
United States

drben@osmosisbeauty.com
Issuing Office:
Division of Human and Animal Food Operations East IV

United States

August 23, 2023

WARNING LETTER

Ref: CMS Case #652059

Dear Dr. Benjamin T. Johnson:

This is to advise you that the U.S. Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 30746 Bryant Dr, Unit 410, Evergreen, CO from January 5, 2023, through January 13, 2023. Following the inspection, we reviewed your product labels for your Osmosis Skin Perfection Elixir, Sugar Detox Elixir, and Elevate products, and your website at the Internet address http://osmosisbeauty.com, from which website you take orders for your Osmosis Skin Perfection Elixir, Sugar Detox Elixir, and Elevate products. The inspection and our review of your product labels and website revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA regulations. You can find the Act and the FDA’s regulations through links on FDA’s home page at http://www.fda.gov.

We received your email response, dated January 31, 2023, which was written in response to the Form FDA 483, Inspectional Observations, issued to you at the close of the inspection. We address your response below.

Unapproved New Drugs and Misbranded Drugs

FDA reviewed your product labels and website in June 2023 and has determined that your Osmosis Skin Perfection Elixir, Sugar Detox Elixir, and Elevate 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 diagnosis, 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 claims that provide evidence that your products are intended for use as drugs include:

Product: Osmosis Skin Perfection Elixir

On your product label:
• “Renowned for its ability to . . . reduce inflammation…”
• “…detoxifies eczema, psoriasis, and inflamed skin”
• “Balances digestive causes of rosacea and neutralizes skin toxins”

On your website, http://osmosisbeauty.com:
• “Skin Perfection contains edible 24-karat gold, and our exclusive, clinically proven technology that targets the source of redness, inflammation, and blemishes.”
• “TOP BENEFITS: Balances digestive causes of Rosacea, Eczema, and Psoriasis, Neutralizes skin toxins”
• “RECOMMENDED FOR: … Eczema/Psoriasis, Rosacea, Other Candida related skin conditions”

Product: Osmosis Sugar Detox Elixir

On your product label:
• “Renowned for its ability to … reduce inflammation…”
• “Harmonizes the pancreas and sugar regulation”

On your website, http://osmosisbeauty.com:
• “Improve sugar regulation, detox sweeteners, and harmonize your pancreas with our Sugar Detox Elixir. This supplement is especially vital for those who have diabetes…”
• “TOP BENEFITS: Harmonizes the pancreas and sugar regulation”
• “RECOMMENDED FOR: Diabetes and related neuropathy, Sugar cravings”

Product: Osmosis Elevate

On your website, http://osmosisbeauty.com:
• “This new and improved version of Elevate … continues to offer clinically proven benefits in reducing cholesterol and triglycerides…”
• “RECOMMENDED FOR: … High blood pressure/cholesterol”

Your above 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)]. With certain exceptions not applicable here, 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 Osmosis Skin Perfection Elixir, Sugar Detox Elixir, and Elevate products are intended for treatment of one or more diseases that, with certain exceptions not applicable here, 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 Osmosis Skin Perfection Elixir, Sugar Detox Elixir, and Elevate 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 this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].

Dietary Supplement CGMP Violations

During the inspection, our investigator found significant violations of FDA’s regulation for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). Based on the inspection, we determined that these violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

Your significant violations of the CGMP requirements are as follows:

1. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, during the inspection, you informed our investigator that you did not have any written procedures for quality control operations.

We received your January 31, 2023, response which states, “[W]e will develop written QC procedures for all areas of the department and formalize them as Standard Operating Procedures (SOPs). Estimated timeline (b)(4).” Your response did not include any written quality control procedures or other evidence that you have implemented corrective actions. Further, you did not indicate whether you will continue production of dietary supplements while you are developing your quality control SOPs.

2. You firm failed to establish and follow written procedures for maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to package, label, or hold your dietary supplements, as required by 21 CFR 111.25(c). For example, you use (b)(4) to remove dust before filling the bottle with product; however, during the inspection, you were unable to provide documentation on the specifications and maintenance of the (b)(4).

We also note that you must implement the required sanitizing procedure by maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and contact surfaces used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.27(d), and you must make and keep cleaning and sanitization records as required by 21 CFR 111.35(a).

3. You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you do not have written procedures for reviewing and investigating product complaints. Once you establish written procedures for the requirements of product complaints, you must include all the requirements in accordance 21 CFR 111.560.

4. You failed to establish and follow written procedures to fulfill the requirements that apply to returned dietary supplements, including the procedures for conducting a material review and making a disposition decision, in accordance with 21 CFR 111.503. Specifically, during the inspection you confirmed that you have no written procedures for handling returned products.

We received your January 31, 2023, response which states, “We will develop an SOP to outline complete information relating to all product returns and restocking of inventory. Estimated timeline (b)(4).” Your response did not include any evidence that you have implemented corrective actions. Further, you did not indicate whether you will continue production of dietary supplements while you are developing your written SOP.

We also note that you must make and keep records of your compliance with such requirements for returned dietary supplements, in accordance with 21 CFR 111.535(b).

5. Your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, during the inspection you confirmed that have no written procedures for the holding and distribution of your dietary supplement products.

We received your January 31, 2023, response which states, “We will develop an SOP for holding and distributing operations of all dietary supplements. Estimated timeline = (b)(4).” Your response did not include any evidence that you have implemented corrective actions. Further, you did not indicate whether you will continue production of dietary supplements while you are developing your written SOP.

We also note that you must make and keep records of such written procedures, as required by 21 CFR 111.475(b)(1).

Misbranded Dietary Supplements

In addition, your Skin Clarifier, Recovery, Regenerate, Immune Defense Elixir, and Elevate products are misbranded dietary supplement within the meaning of section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements. Specifically, we identified the following:

a) Your Osmosis Elevate, Skin Clarifier, Recovery, and Regenerate products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event.

b) Your Osmosis Immune Defense Elixir product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C § 343(q)(1)(A)], because the serving sizes declared on the label is incorrect and/or incomplete. 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. For example, your product label only lists the serving size for one of the intended consumer groups listed in the “Suggested Use” panel. As your product is intended for varying weight groups, you must list the serving size for each group in your Supplement Facts label.

c) Your Osmosis Recovery, Elevate, Skin Clarifier, and Immune Defense Elixir products are misbranded with the meaning of 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 does not comply with 21 CFR 101.36. For example:

• Your Osmosis Recovery product,
- declares Calories from Fat; however, there is no provision for this declaration in the Supplement Facts label. [21 CFR 101.36(b)(2)(i)]
- fails to correctly place Calories, a (b)(2)-dietary ingredient along with any other (b)(2)-dietary ingredient below the headings “Amount Per Serving” and % Daily Value. [21 CFR 101.36(b)(2)(iii)(B)]
- declares an incorrect Total Fat % Daily Value based upon the quantitative amount of 15 grams per serving [21 CFR 21 CFR 101.36(b)(2)(iii)(B)].
- declares “unsaturated fat” in the Supplement Facts label.; there is no provision for this in the regulation. However, there is a provision for the voluntary declaration of monounsaturated or polyunsaturated fat. [21 CFR 101.9(c)(2) and 21 CFR 101.36(b)(2)(i)]
- fails to indent the list of ingredients of the proprietary blend below the name “Proprietary Blend”. Likewise, the listed fatty acid constituents must be indented below the list of proprietary blend ingredients [21 CFR101.36(c)(2))

• Your Osmosis Elevate product incorrectly lists potassium, a (b)(2)-dietary ingredient in the Supplement Facts label. Any (b)(2)-dietary ingredient that is not present, or that is present in an amount that can be declared as zero in section 21 CFR 101.9(c), must not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). The source of the ingredient, i.e., potassium citrate must be listed in the Other Ingredients list. [21 CFR 101.36(b)(2)(i)]
• Your Osmosis Immune Defense Elixir fails to provide the quantitative amount and percent of Daily Value for each intended group in accordance with 21 CFR 101.36(b)(2)(iii)(E).
• Your Osmosis Recovery, Regenerate, Skin Clarifier and Immune Defense Elixir products fail to set the “Supplement Facts” full width of the nutrition label. [21 CFR 101.36(e)(1)]
• Your Osmosis Regenerate and Skin Clarifier products fail to declare the quantitative amount by weight of each dietary ingredient per serving using metric measures in appropriate units (i.e., 1000 units must be declared in the next higher set of units, e.g., 1,100mg must be expressed as 1.1 g) in accordance with 21 CFR 101.36(b)(3)(ii)(A). Likewise, milligram or milliliter declarations should be rounded to the nearest unit.
• Your Osmosis Skin Clarifier declares enzyme assay units in the Supplement Facts label, however, there is no provision in the regulation for this declaration.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

We also offer the following comments:
• The statement of identity “dietary supplement” on your Osmosis Skin Clarifier, Elevate, Recovery, Regenerate and Immune Defense Elixir products must be presented in bold type on the principal display panel, in a size reasonably related to the most prominent printed matter on the panel in accordance with 21 CFR 101.3(d).
• Your Osmosis Elevate, Skin Clarifier, Recovery, Regenerate, Immune Defense Elixir product labels each fail to bear a symbol next to all structure/function claims linking the claim to the disclaimer, in accordance with 21 CFR 101.93 and (d). For example, we note use of the term “wellness” is a structure function claim.
• Your Osmosis Skin Clarifier product declares “herb” which is not a plant part. If the entire or whole plant is used, then that information must be declared.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: Kathy Tormey, Compliance Officer; 6th Avenue and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado, 80225-0087 or via email at Kathleen.tormey@fda.hhs.gov. You may reach Ms. Tormey at (303) 236-3137 if you have any questions about this matter.

Sincerely,

/S/
E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations -
West Division 4

 
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