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  5. GeroNova Research Inc. - 612777 - 11/18/2021
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WARNING LETTER

GeroNova Research Inc. MARCS-CMS 612777 —

Delivery Method:
United Parcel Service
Product:
Drugs
Recipient:
Recipient Name
Karyn Young
Recipient Title
President
GeroNova Research Inc.

2600 Hilltop Dr
Bldg B, Ste C120
Richmond, CA 94806
United States

Issuing Office:
Office of Human and Animal Food Operations - West Division 5

United States

WARNING LETTER


WL 612777

November 18, 2021

Dear Karyn Young:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your Amazon.com store, which operates under the name GeroNova Research Inc., in September to October 2021 and has determined that you take orders there for the products CARNITINE PLUS Vegcaps, GeroNova Beauté Infinie Elixir (also referred to as Liquid L-Carnitine and Liquid CARNITINE-PLUS), R-Lipoic Acid Vegcaps 300 mg, and R-Lipoic Acid Vegcaps 100 mg. We also reviewed your social media websites at www.facebook.com/GeroNovaResearch and www.twitter.com/geronova, both of which direct consumers to your website www.geronova.com, which directs consumers to your Amazon.com store to purchase your products. 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 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. 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 your Facebook page, https://www.facebook.com/GeroNovaResearch/, from a February 20, 2018 post entitled “Exciting News in the World of #Carnitine!”, which discusses carnitine, an ingredient in CARNITINE PLUS Vegcaps and GeroNova Beauté Infinie Elixir, and hyperlinks to the CARNITINE PLUS Vegcaps page of your website www.geronova.com, which contains a “Buy on Amazon” button that directs consumers to your Amazon.com store to purchase this product:

• “For example, research demonstrated that mitochondrial dysfunction, aging, autism, cardiomyopathy, many errors in metabolism, dislipidemia, and renal disease are among just a few of the remarkable clinical areas in which the addition of carnitine supplementation demonstrated an essential role in improved outcomes.”
• “A systematic review and meta-analysis that investigated the effect of supplemental Acetyl-L-Carnitine (do not confuse with other forms of carnitine) on ‘depressive symptoms across randomized controlled trials’ concluded that supplemental Acetyl-L-Carnitine: ‘significantly decreases depressive symptoms compared with placebo/no intervention, while offering a comparable effect with that of established antidepressant agents with fewer adverse effects.’”
• “In fascinating Parkinson's disease pre-clinical research modeling, Acetyl-L-Carnitine improved cognitive function, extended neuronal survival and modulated key imbalances between cytokines.”

On your Facebook page, https://www.facebook.com/GeroNovaResearch/, from a September 1, 2018 post entitled “While Pharma Industry Scrambles for the Fountain-of-Youth, New Research Demonstrates Again: Anti-Aging is Available Right Now!”:
• “[R]esearch demonstrated that acetyl-l-carnitine [an ingredient in your CARNITINE PLUS Vegcaps] supplementation inhibited insulin resistance through AMPK stimulation… acetyl-l-carnitine administration: Restored Sirtuin-3 activity . . .”
• “A key cardio-protective area involved R-Lipoic Acid’s [an ingredient in your R-Lipoic Acid Vegcaps 300 mg and R-Lipoic Acid Vegcaps 100 mg] ability to improve a pivotal pathological disease-state (called endothelial dysfunction) through several mechanisms, including the ability to increase AMPK. [footnote omitted] Cumulative research also revealed R-Lipoic Acid’s established ability to …
  o ‘Possess anti-diabetic and anti-obesity properties,’ [footnote omitted] as it both increases insulin sensitivity through AMPK activation [footnote omitted] and a reduces insulin in pancreatic beta cells [footnote omitted]
  o Improve mitochondrial function in Nonalcoholic Steatosis (liver disease) by stimulating Sirtuin-1 and Sirtuin-3 proteins [footnote omitted]”
• “Did you know that the body naturally produces impressive anti-aging compounds such as ‘sirtuins’ and ‘AMP Kinase (AMPK) [which you claim are increased or stimulated by R-Lipoic Acid and acetyl-l-carnitine]?’ Cumulative research established that these proteins set off a cascade of crucial functions in the body, including…Anti-tumor effect…What is more, research demonstrated that a reduction in sirtuins was associated with aggressive disease-states such as diabetes and insulin resistance…Equally as important, a reduction in AMPK was associated with cardiomyopathy…”

On your Twitter page, www.twitter.com/geronova:
• You retweeted another user’s October 6, 2018 tweet, which said, “Carnitine [an ingredient in CARNITINE PLUS Vegcaps and GeroNova Beauté Infinie Elixir] does so much in this one. #diabetes . . .” and retweeted the following tweet you posted on July 27, 2018: “Key to energy production, new research study shows “#carnitine supplementation stabilises hyperglycaemia and increases the metabolism of pyruvate in the diabetic heart. l-carnitine provides a means to improve pyruvate metabolism in the #diabetic heart . . .”
• You retweeted another user’s September 26, 2014 tweet, which said, “#lipoicacid [an ingredient in your R-Lipoic Acid Vegcaps 300 mg and R-Lipoic Acid Vegcaps 100 mg] model treats autonomic neuropathy… @geronova is the best! I’ve tried it.”

On your Amazon.com product page for CARNITINE PLUS Vegcaps, https://www.amazon.com/geronova-research-carnitine-supplement-effective/dp/B08KS1SF36/ref=sr_1_5?dchild=1&keywords=carnitine+plus&qid=1634152800&sr=8-5:
• “IMPROVE BLOOD SUGAR LEVELS: Studies have shown that L-carnitine … while improving insulin resistance.*”

On your Amazon.com product page for GeroNova Beauté Infinie Elixir, https://www.amazon.com/L-Carnitine-Absorption-Magnesium-Metabolism-Supplements/dp/B08L3W3VMP/ref=sr_1_1?dchild=1&keywords=l+carnitine+liquid&qid=1633638420&refinements=p_78%3AB08L3W3VMP&sr=8-1:
• “IMPROVE BLOOD SUGAR LEVELS: Studies have shown that L-carnitine … while improving insulin resistance.*”
• “. . . slows signs of . . . cardiovascular and neurological disorders”

Unapproved New Drugs
Your 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 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 the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. § 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

Misbranded Drugs
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 CARNITINE PLUS Vegcaps, GeroNova Beauté Infinie Elixir, R-Lipoic Acid Vegcaps 300 mg, and R-Lipoic Acid Vegcaps 100 mg 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 CARNITINE PLUS Vegcaps, GeroNova Beauté Infinie Elixir, R-Lipoic Acid Vegcaps 300 mg, and R-Lipoic Acid Vegcaps 100 mg 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)].

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 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 response should be sent to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Food Operations - West Division 5
1201 Harbor Bay Parkway
Alameda, CA 94502

Or via email to ORAHAFWEST5FirmResponses@fda.hhs.gov.

Refer to Unique Identification Number 612777 when replying.

If you have any questions regarding this letter, please contact Clarice J. Ahn, Compliance Officer, at clarice.ahn@fda.hhs.gov.

Sincerely,
/S/

Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations - West Division 5

 
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