WARNING LETTER
Anabolic Laboratories Inc
MARCS-CMS 636308 —
November 14, 2022
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Dietary Supplements
Drugs
Recipient:
Recipient Name
Mr. Kyle Brown
Anabolic Laboratories Inc
26021 Commercentre Dr.
Lake Forest
,
CA
92630-8853
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
November 14, 2022
RE: CMS # 636308
Dear Mr. Kyle Brown:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://www.anaboliclabs.com/Default.aspx in August 2022 and has determined that you take orders there for your CoQ10 Ubiquinol Prime and Policosanol Microtabs products. The claims on your websites 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 this product 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 CoQ10 Ubiquinol Prime and Policosanol Microtabs are intended for use as a drug include the following:
On your CoQ10 Ubiquinol Prime product page at https://www.anaboliclabs.com/ProductDetails.aspx?ID=137:
"In patients undergoing surgery for cardiopulmonary bypass, those receiving CoQ10 treatment were significantly less likely to require inotropic drugs after surgery and to develop ventricular arrhythmias. Also, a randomized controlled multicenter trial evaluated CoQ10 as adjunctive treatment in 420 patients with chronic heart failure. Long- term CoQ10 treatment was found to be safe, improve symptoms, and reduce major adverse cardiovascular events. In another study, the administration of CoQ10 to heart transplant candidates led to significant improvements in functional status, clinical symptoms, and quality of life."
"[I]mprovement in plasma CoQ10 was correlated with both clinical improvements and improvement in left ventricular function in heart failure patients"
"The ubiquinol form of CoQ10 is beneficial for people who may have increased needs for CoQ10 or who are at high risk for decreased conversion of ubiquinone to ubiquinol, such as those on statins or other CoQ10 depleting medications, older individuals, and those with certain health conditions, especially heart disease."
On your Policosanol Microtabs product page at https://www.anaboliclabs.com/ProductDetails.aspx?ID=30
"Contains over 50% Octacosanol, ...found to manage lipid accumulation in fatty tissue and oxidation in the blood stream”
“Naturally contains eight other higher primary aliphatic acids that assist in lowering cholesterol”
Your CoQ10 Ubiquinol Prime and Policosanol Microtabs products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are a “new drug” 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 product CoQ10 Ubiquinol Prime is 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 product safely for its intended purposes. Accordingly, CoQ10 Ubiquinol Prime fails to bear adequate directions for its intended use and, therefore, this product is 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)].
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 these matters may result in legal action including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address these matters. 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written reply should be directed to Dr. Aaron Dotson, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835 or via email at CFSANResponse@fda.hhs.gov. If you have any questions, you may also email at CFSANResponse@fda.hhs.gov.
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Food and Drug Administration
Content current as of:
11/17/2022
Regulated Product(s)
Dietary Supplements
Drugs