WARNING LETTER
3RD Day Nutraceuticals, LLC
MARCS-CMS 614321 —
July 08, 2021
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Michael Zammett
Recipient Title
Owner
3RD Day Nutraceuticals, LLC
225 N Main St, Suite 404
Bristol
,
CT
06010
United States
Issuing Office:
Office of Human and Animal Food Operations East – Division 1
United States
WARNING LETTER
CMS# 614321
Dear Mr. Zammett:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://3rddaynutra.com/ in April 2021 and has determined that you take orders there for the products Immune Booster, Allergy Support, Inflammatory Response Support, and Revive & Recover. The claims on your website 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:
The product page for your Immune Booster product states:
“Pink Grapefruit [listed as an ingredient in your proprietary blend for Immune Booster]: Exhibits antibacterial properties as well as promotes defenses against tumor cells.”
“Bay Laurel [listed as an ingredient in your proprietary blend for Immune Booster]: Exhibits anti‐bacterial properties…”
“Rose Water [listed as an ingredient in Immune Booster]: Exhibits anti‐bacterial and antiinflammatory properties.”
“Lemon [listed as an ingredient in your proprietary blend for Immune Booster]: Exhibits antibacterial and antifungal properties as well as promotes defenses against tumor cells.”
“Bergamot [listed as an ingredient in your proprietary blend for Immune Booster]: Exhibits antiviral and antibacterial properties.”
“Honey [listed as an ingredient in Immune Booster]: antibacterial…properties.”
“Vitamin C [identified on the Supplement Facts Label for Immune Booster]: Promotes anti‐viral activity…”
The product page for your Allergy Support product states:
“Allergy Support….each ingredient…support allergy relief..”
“20+ years of suffering from allergies and taking prescription/OTC medications lead to the need for a change…There are a few days throughout the year where the symptoms are so severe that a decongestant or other OTC medication is necessary…For intermittent or regular use, these capsules have worked...”
“Blue Spirulina [Spirulina, Blue-Green Whole Plant is listed as an ingredient in your proprietary blend for Allergy Support]: Has been found to reduce inflammation associated with nasal passage, can decrease histamine levels and immunoglobulin E.”
“Quercetin [Quercetin Dihydrate is listed as an ingredient in your proprietary blend for Allergy Support]: Effectively inhibits the release of histamines as well as blocks pro‐inflammatory cytokines, such as IL‐6 & TNF.”
“Turmeric [Turmeric Root is listed as an ingredient in your proprietary blend for Allergy Support]: Suppresses pro‐inflammatory cytokines, relieving airflow resistance and reducing sneezing. Also effective at reducing the release of histamine.”
“Stinging Nettle [Nettle Leaf is listed as an ingredient in your proprietary blend for Allergy Support]: Inhibits inflammatory enzymes produced by mast cells, inhibits prostaglandin and prevents binding of histamine to cellular receptors.”
“Bromelain [is listed as an ingredient in your proprietary blend for Allergy Support]:The properties of these enzymes have been shown to reduce inflammation in the nasal passage and upper respiratory tract.”
“Ginger Root [is listed as an ingredient in your proprietary blend for Allergy Support]:The active ingredient 6‐gingerol has been shown to suppress cytokine production, reducing mast cell production and alleviating rhinitis symptoms.”
The product page for your Inflammatory Response Support product states:
“Inflammation isn’t always a bad thing, in fact it’s a natural response your body uses to protect itself from things like foreign invaders (i.e. viruses) or utilizes to initiate the repair process needed when you sustain an injury. But, more and more the population is plagued by chronic inflammation or inflammatory‐related diseases and those effects can be detrimental to your overall health and well being. As a daily supplement, there are powerful components within the herbs and fruits in this extract to help fend off the adverse effects associated with inflammation.”
“We began looking into researching plants, fruits and herbs that have anti-inflammatory properties when we came to the realization that our consistent need for ibuprofen was probably not beneficial to our overall health. . . . [W]e wanted to see if there was another option to avoid some of the adverse effects those can cause (such as the stress they can put on your kidneys). After exhaustive research and development…this concentrate was formulated. As a daily part of our diets, this nutraceutical is helping manage ‘bad’ or over inflammation . . ..”
“Calendula [listed as an ingredient in your proprietary blend for Inflammation Response Support]: Contains many tri‐terpene alcohols responsible for inhibiting inflammatory pathways.”
“Copaiba [Copaiba oil is listed as an ingredient in your Inflammation Response Support]: Active oleoresins containing high levels of terpenes aid in suppressing inflammation . . .”
“Turmeric [Turmeric root is listed as an ingredient in your proprietary blend for Inflammation Response Support]: Curcumin is the active ingredient responsible for inhibiting pro-inflammatory enzymes as well as cytokine expression.”
“Olive Leaf [listed as an ingredient in your proprietary blend for Inflammation Response Support]: Active polyphenol, oleuropein, reduces the release of pro-inflammatory cytokines”
The product page for your Revive & Recover product states:
“This kit is intended to help combat the negative effects experienced when you consume alcohol. We have combined plant extracts, antioxidants, vitamins, minerals and other naturally occurring compounds to help you fight the battle.”
“Glutathione [listed as an ingredient in your proprietary blend for Revive & Recover]: Breaks down the toxic by‐product of alcohol metabolism, acetaldehyde.”
“Ginger Root (organic) [listed as an ingredient in your proprietary blend for Revive & Recover]: . . . Helpful in reducing nausea.”
“Quercetin [listed as an ingredient in your proprietary blend for Revive & Recover]: A natural anti‐histamine, and helps prevent alcohol-induced liver damage.”
“Nopal Cactus (organic) [listed as an ingredient in your proprietary blend for Revive & Recover]: Shown to reduce nausea, inflammation”
“Vitamin B12 [listed in the Supplement Facts Label for Revive & Recover]: Alcohol increases histamine and homocysteine. B12 breaks these down and helps to prevent liver damage.”
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 Immune Booster, Allergy Support, Inflammatory Response Support, and Revive & Recover 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, Immune Booster, Allergy Support, Inflammatory Response Support, and Revive & Recover 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 matters that may exist in connection with your products. You are responsible for investigating and determining the causes of any matters 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 response should be sent to the U.S. Food and Drug Administration, Attention: Scott R. Izyk, Compliance Officer, 1 Winners Circle, Suite 140, Albany, NY 12205 or by e-mail (preferred) to scott.izyk@fda.hhs.gov.
Sincerely,
/S/
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations
East – Division 1
Content current as of:
08/10/2021
Regulated Product(s)
Food & Beverages