3RD Day Nutraceuticals, LLC
FDA issued a warning letter to 3RD Day Nutraceuticals, LLC (Bristol, CT) after reviewing its website in April 2021 and finding that four products — Immune Booster, Allergy Support, Inflammatory Response Support, and Revive & Recover — bore disease-treatment and drug-effect claims that caused them to be regulated as unapproved new drugs under the FD&C Act. The claims included antibacterial, antiviral, anti-inflammatory, histamine-suppression, and liver-damage-prevention language tied to specific ingredients, none of which had FDA approval for such uses. The products were also deemed misbranded for lacking adequate directions for use. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (26)
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.
Honey [listed as an ingredient in Immune Booster]: antibacterial…properties.
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.
Allergy Support….each ingredient…support allergy relief..
Glutathione [listed as an ingredient in your proprietary blend for Revive & Recover]: Breaks down the toxic by‐product of alcohol metabolism, acetaldehyde.
Vitamin C [identified on the Supplement Facts Label for Immune Booster]: Promotes anti‐viral activity…
Quercetin [listed as an ingredient in your proprietary blend for Revive & Recover]: A natural anti‐histamine, and helps prevent alcohol-induced liver damage.
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.
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 . . ..
Rose Water [listed as an ingredient in Immune Booster]: Exhibits anti‐bacterial and antiinflammatory properties.
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.
Olive Leaf [listed as an ingredient in your proprietary blend for Inflammation Response Support]: Active polyphenol, oleuropein, reduces the release of pro-inflammatory cytokines
Bay Laurel [listed as an ingredient in your proprietary blend for Immune Booster]: Exhibits anti‐bacterial properties…
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.
Calendula [listed as an ingredient in your proprietary blend for Inflammation Response Support]: Contains many tri‐terpene alcohols responsible for inhibiting inflammatory pathways.
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.
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.
Pink Grapefruit [listed as an ingredient in your proprietary blend for Immune Booster]: Exhibits antibacterial properties as well as promotes defenses against tumor cells.
Nopal Cactus (organic) [listed as an ingredient in your proprietary blend for Revive & Recover]: Shown to reduce nausea, inflammation
Bergamot [listed as an ingredient in your proprietary blend for Immune Booster]: Exhibits antiviral and antibacterial properties.
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.
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.
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.
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...
Copaiba [Copaiba oil is listed as an ingredient in your Inflammation Response Support]: Active oleoresins containing high levels of terpenes aid in suppressing inflammation . . .
Required actions (2)
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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