WARNING LETTER
Lipotriad LLC
MARCS-CMS 612206 —
March 19, 2021
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Mr. Kenneth Krieg
Recipient Title
CEO
Lipotriad LLC
5 Sentry Parkway East Suite 210
Blue Bell
,
PA
19422
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
March 19, 2021
WARNING LETTER
CMS # 612206
Dear Mr. Krieg:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.lipotriadvitamins.com in November 2020 and has determined that you take orders there for the products Lipotriad Visionary, Lipotriad Adult 50+, Lipotriad Dry Eye, and Lipotriad Vision Support Plus. We also reviewed your social media websites at https://www.facebook.com/LipotriadVitamins and https://twitter.com/Lipotriad, where you direct consumers to your website, https://www.lipotriadvitamins.com, to purchase your products. The claims on your website and your social media 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 and social media claims that provide evidence that your products are intended for use as drugs include:
On your webpage at https://lipotriadvitamins.com/apps/stream:
“[S]tart taking vitamins to help fight against eye diseases. To learn more about our vitamins visit @lipotriadvitamins”
“By protecting your eyes, you will reduce the odds of blindness and vision loss while also staying on top of any developing eye diseases such as cataracts and glaucoma. To learn more about our vitamins visit @lipotriadvitamins”
On your Facebook page at https://www.facebook.com/LipotriadVitamins in the “About” section:
“Lipotriad vitamins are . . . both for dry eyes and for the prevention of macular degeneration.”
Lipotriad Visionary
On your “what is inside lipotriad visionary” page at https://lipotriadvitamins.com/pages/what-is-inside-lipotriad-visionary
“250mg of Fish Oil, (200mg Omega -3 Fatty Acids, 125mg DHA, 50mg EPA) [an ingredient in your Lipotriad Visionary product] . . . In addition supplementing with fish oil has led to a lower risk of heart disease and a reduction of chronic inflammation that can lead to a variety of serious diseases, including cancer and stroke.”
On your Twitter page at https://twitter.com/Lipotriad:
[Beneath a picture of your Lipotriad Visionary product:] “Eye Vitamins to help prevent the onset of macular degeneration.”
Lipotriad Adult 50+
On your product webpage for Lipotriad Adult 50+ at https://lipotriadvitamins.com/products/lipotriad-adult-50-eye-vitamin-mineral-supplement-60-enteric-coated-softgels
“DOUBLE THE LUTEIN (10mg) & 2.5mg ZEAXANTHIN: Our Adult 50+ Formula contains double the lutein when compared to leading Adult 50+ Eye Vitamin Formulas. These ingredients protect the macula and filter out harmful blue rays.”
“1 PER DAY: Only 1 Softgel Per Day gives your eyes all the Nutrients it needs to protect your vision and prevent deterioration.”
“250MG OMEGA 3 FISH OIL [an ingredient in your Lipotriad Adult 50+ product]: Keeps eyes protected . . . and reduces dry eye symptoms.”
Lipotriad Dry Eye
On your product webpage for Lipotriad Dry Eye at https://lipotriadvitamins.com/products/lipotriad-dry-eye-60ct
“Lipotriad Dry Eye”
“Recommended for: . . . Dry Eye Support”
Lipotriad Vision Support Plus
On your product webpage for Lipotriad Vision Support Plus at https://lipotriadvitamins.com/products/lipotriad-vision-support-plus-60ct
“20mg of Lutein [an ingredient in your Lipotriad Vision Support Plus product] . . . Helps protect the macula and filter out harmful radiation”
“Lipotriad Vision Support Plus is a special formulation of of [sic] nutrients and antioxidants focused on protecting . . . Optic Nerve function . . .”
“The new formula contains 20mg of Lutein, 200IU Natural Vitamin E, 80mg of Bilberry (Herbal), 100mg of Grape Seed and 6 other key ingredients that protect optic nerve function . . . These ingredients . . . block out dangerous uv rays that can damage nerve cells . . . and protect the macula.”
Your Lipotriad Visionary, Lipotriad Adult 50, Lipotriad Dry Eye, and Lipotriad Vision Support Plus 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 Lipotriad Visionary, Lipotriad Adult 50, Lipotriad Dry Eye, and Lipotriad Vision Support Plus products are intended for prevention of one or more diseases that are not amenable to selfdiagnosis 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, Lipotriad Visionary, Lipotriad Adult 50, Lipotriad Dry Eye, and Lipotriad Vision Support Plus 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 written response should be sent to the following address: U.S. Food and Drug Administration, 6000 Metro Drive, Suite #101, Baltimore, Maryland 21215. If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia, Compliance Officer, or by e-mail to Andrew Ciaccia at Andrew.Ciaccia@fda.hhs.gov. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact Andrew Ciaccia at
(973) 331-4904
.
Sincerely,
/S/
Randy Pack
Program Division Director
Division Director
Human & Animal Food Division II East
Baltimore District Office
Content current as of:
03/30/2021
Regulated Product(s)
Drugs