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WARNING LETTER

Source-Omega LLC MARCS-CMS 652322 —

Delivery Method:
United Parcel Service
Product:
Drugs
Recipient:
Recipient Name
Scott D. Doughman
Recipient Title
Owner
Source-Omega LLC

260 E Forest Ave
South Lebanon, OH 45065
United States

Issuing Office:
Division of Human and Animal Food Operations East V

United States

Warning Letter # 652322

August 8, 2023

Dear Mr. Doughman:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the internet address www.source-omega.com in May, 2023 and has determined that you take orders there for the products Source Oil Rosemary Algae Omega-3, Source Oil Organic Lemon Algae Omega-3, and Source Oil Organic Orange Algae Omega-3. The claims on your websites establish that the 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 website claims that provide evidence that your products are intended for use as drugs include:

On the webpage titled “Alzheimer’s Onset”:

  • “Because of a John’s Hopkins Health Alert, I’ve started taking appropriate levels ofomega-3 DHA (docosahexaenoic acid) [a nutrient in Source Oil Rosemary AlgaeOmega-3, Source Oil Organic Lemon Algae Omega-3, and Source Oil Organic Orange Algae Omega-3]. According to the Health Alert 1,000 mg/day DHA alone could help prevent up to 70% of Alzheimer’s cases.”
  • “DHA [a nutrient in Source Oil Rosemary Algae Omega-3, Source Oil Organic Lemon Algae Omega-3, and Source Oil Organic Orange Algae Omega-3] can be more effective for lowering triglycerides or preventing cognitive deficiencies than many drugs.”

On the webpage titled “Peak Long-Chain Omega-3s May Double Anti-Cancer Benefits”:

  • “Peak Long-Chain Omega-3s May Double Anti-Cancer Benefits”

Your website also includes disease claims in the form of citations to publications or references. On the website https://www.source-omega.com/our-peer-reviewed-publications/, under peer reviewed publication 2: Scott D. Doughman, Srirama Krupanidhi, and Carani B. Sanjeevi. “OMEGA-3 FATTY ACIDS FOR NUTRITION AND MEDICINE: CONSIDERING MICROALGAE OIL AS A VEGETARIAN SOURCE OF EPA AND DHA” Curr Diabetes Rev. 2007, 3:198-203; Bentham Scientific Publications.

  • “[P]ossible protective mechanisms of EPA/DHA in major diseases such as coronary heart disease, atherosclerosis, cancer and type 2 diabetes…”

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)]. 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 products Source Oil Rosemary Algae Omega-3, Pure One Algae Omega-3, Source Oil Organic Lemon Algae Omega-3, and Source Oil Organic Orange Algae Omega-3 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, Source Oil Rosemary Algae Omega-3, Pure One Algae Omega-3, Source Oil Organic Lemon Algae Omega-3, and Source Oil Organic Orange Algae Omega-3 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)].

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.

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.

Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Christopher N. Dedeaux, Compliance Officer, via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or at 404 BNA Drive, Suite 500, Nashville, TN 37217. You may reach Mr. Dedeaux at 504-846-6122 or via email at Christopher.Dedeaux@fda.hhs.gov if you have any questions about this matter.

Sincerely,
/S/

Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East

 
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