WARNING LETTER
Synaptent, LLC
MARCS-CMS 610683 —
November 09, 2021
Delivery Method:
Email
Product:
Food & Beverages
Recipient:
Recipient Name
Armand Tuzel/Marek Wiszniewski
Recipient Title
Managing Members
Synaptent, LLC
47 West Polk Street, 100-241
Chicago
,
IL
60605
United States
Issuing Office:
Office of Human and Animal Food Operations-East 6
United States
WARNING LETTER
FY22-HAFE6-WL-01
November 9, 2021
Dear Mr. Tuzel and Mr. Wiszniewski,
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.liftmode.com in August to October 2021 and has determined that you take orders there for the products Phenibut FAA, Phenibut HCl, Baicalein, Berberine HCL, Curcumin, Fisetin, Lion’s Mane, Milk Thistle, Quercetin, Boswellia Serrata Extact, Dihydromyricetin (DHM), Honokiol, Magnolia Bark Extract, Tongkat Ali Extract (Eurycoma longifolia root extract), L- Tetrahydropalmatine (L-THP), Tribulus Terrestris Extract, and Garlic Extract. The claims on your website establish that the products are drugs under section 201(g)(1) of the Act [21 U.S.C. §321(g)(1)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. 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:
Phenibut FAA (all strengths)& Phenibut HCl (all strengths and varieties)
On a page titled “Phenibut” in the “Calm” section of your website:
• “Phenibut or β-Phenyl-γ-aminobutyric Acid is a nootropic compound with GABA-B agonist and α2δ subunit-containing voltage-dependent Ca2+ channel blocker activity, that has neuroprotective and anxiolytic properties.”
On the product pages for Phenibut FAA & Phenibut HCl:
• “Phenibut . . . is said to support relaxation, restful sleep, and positive mood.”
On the product pages for Phenibut FAA & Phenibut HCl, you provide graphics of the labels of the products that state:
• “Boost Your Mood [] Reduce Your Stress”
Baicalein
Product webpage:
• “Baicalein also acts as a strong anti-inflammatory . . .”
• “Anti-inflammatory” [located on the image of the product label]
Berberine HCL
Product webpage:
• “It . . . was once used as a treatment for diarrhea in diabetics.”
• “It is especially beneficial for use by diabetics and people with high cholesterol, who are at risk of developing diabetes.”
• “Powerful Anti-inflammatory” [located on the image of the product label]
Curcumin
Product webpage:
• “Powerful Anti-inflammatory” [located on the image of the product label]
• “Curcumin is an extremely powerful anti-inflammatory . . .”
Fisetin
Product webpage:
• “Fisetin is a potent anti-inflammatory agent and directly inhibits the activity pro-inflammatory cytokines such as TNFα, NF-κB, and IL6.”
Lion’s Mane
Product webpage:
• “Anti-Inflammatory” [located on the image of the product label]
The “Lion’s Mane” page in the “Cognition” section of your website:
• “Lion’s Mane contains polysaccharides such as heteroglucans which protect the nervous system by improving neurite outgrowth in the brain – meaning they increase the growth of new axons and dendrites, components of brain cells, which may reduce inflammation in the brain and protect it from cell degeneration.”
Milk Thistle
Product webpage:
• “The Silymarin content within Milk Thistle extract has been found to . . . reduce insulin resistance . . ..”
The “Milk Thistle Extract” page in the “Immune” section of your website:
• “Milk Thistle has been shown to exhibit anti-inflammatory. . . properties . . .”
Quercetin
Product webpage:
• “Powerful Anti-inflammatory” [located on the image of the product label]
Boswellia Serrata Extract
Product webpage:
• “The resin extracted from Boswellia serrata is an extremely powerful anti-inflammatory due to its ability to prevent the biosynthesis of leukotrienes, which has been found to be a major source of inflammation in the body.”
• “Powerful Anti-Inflammatory” [located on the image of the product label]
The “Boswellia Serrata Extract” page in the “Health” section of your website:
• “Boswellia serrata . . . is taken . . . for its perceived effect in reducing joint pain . . .”
• “Boswellia serrata . . . has been used . . . as a remedy for diarrhoea [sic] and inflammation.”
Dihydromyricetin (DHM)
The “Dihydromyricetin (DHM)” page in the “Health” section of your website:
• “Dihydromyricetin . . . is used for anti-inflammatory, anti-hangover . . . benefits.”
• “Research in animal studies suggests several important mechanisms of action relating to DHM’s ability to protect against hangovers: . . .
o It helps to reduce fatty acid accumulation in the liver
o DHM reduced the expression of inflammation markers in the liver, including IL-1β, NF- κB, and TNF-α.”
• “It is taken commonly to help reduce the symptoms of hangover and protect the liver against inflammation, especially caused by alcohol use.”
Product webpage:
• “Plants with high levels of dihydromyricetin are commonly incorporated into traditional Chinese medicine (TCM) and traditional japanese [sic] medicine (Kampo) for fevers, jaundice and other inflammatory illnesses.”
• “More recently, Dihydromyricetin has received attention for its purported anti-hangover activity. Several studies suggest that it may lower markers of inflammatory liver disorders. Anecdotal reports indicate that this may carry over to alcohol-induced liver inflammation.”
• “Dihydromyricetin lowers expression of IL-1β, NF-κB, TNF-α, as well as several other inflammatory cytokines. These proteins are responsible for signal pathways involved in immune dysfunction, inflammatory diseases . . ..”
• “Powerful Anti-Inflammatory” [located on the image of the product label]
Honokiol
Product webpage:
• “Studies indicate that Honokiol can be used as a powerful . . . anti-inflammatory, and antimicrobial . . .”
Magnolia Bark Extract
Product webpage:
• Magnolia Bark Extract is an ingredient . . . containing the beneficial ingredients Honokiol and Magnolol. . . . Honokiol and Magnolol have numerous protective health benefits based on their . . . antibacterial, antineoplastic . . . effects.”
Tongkat Ali Extract (Eurycoma longifolia root extract)
Product webpage:
• “Tongkat Ali (
Eurycoma longifolia
) . . . has long been traditionally used as a medicinal plant in a variety of folk medicine preparations for ailments which range from malaria to erectile dysfunction.”
L-Tetrahydropalmatine (L-THP)
Product webpage:
• “Anti-Inflammatory” [located on the image of the product label]
Tribulus Terrestris Extract
The “Tribulus Terrestris” page of the “Passion” section of your website:
• “It is also taken anecdotally for blood pressure control due to its potential diuretic activity and general cardioprotective activity”
Garlic Extract
The “Garlic Extract” page of the “Immune” section of your website:
• “Studies have highlighted the role of garlic in preventing and managing bacterial and fungal infections.”
• “Clinical trials also suggest that garlic may improve heart health by reducing blood pressure. Most clinical trials support the role of garlic supplementation in lowering blood pressure.”
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 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 based on 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” mean 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 Berberine HCL, Magnolia Bark Extract, Tongkat Ali Extract, Tribulus Terrestis Extract and Garlic Extract 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 products Berberine HCL, Magnolia Bark Extract, Tongkat Ali Extract, Tribulus Terrestis Extract and Garlic Extract 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)].
Misbranded Dietary Supplements
Your Baicalin, Curcumin, DHM, and Milk Thistle Extract 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 labeling is incomplete. Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b) followed by the equivalent metric quantity in parentheses.
We note, your Baicalin, Curcumin, DHM, and Milk Thistle Extract products’ labeling fails to declare a complete and accurate statement of the net quantity of contents. For example, the product label expresses the net weight in metric units but fails to express the weight in terms of avoirdupois pound and ounce as required by 21 CFR 101.7(b)(1). For packages labeled in terms of weight, the net quantity of contents shall be expressed in pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, as required by 21 CFR 101.7(j)(1).
Conclusion
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 FD&C Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to U.S. Food and Drug Administration, Lauren Crivellone, Compliance Officer, Food and Drug Administration, 550 West Jackson Boulevard, Suite 1500, Chicago, IL 60661. If you have any questions with regards to this letter, please contact Lauren Crivellone at (312) 596-4157 or email at lauren.crivellone@fda.hhs.gov.
Sincerely,
/S/
William Weissinger, MS
Program Division Director
Office of Human and Animal Food
Operations-East 6
Content current as of:
12/07/2021
Regulated Product(s)
Food & Beverages