WARNING LETTER
Flora Inc
MARCS-CMS 613310 —
June 07, 2021
Delivery Method:
Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Thomas O. Greither
Recipient Title
President
Flora Inc
805 E. Badger Rd.
Lynden
,
WA
98264-9502
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
June 7, 2021
In reply, refer to CMS 613310
WARNING LETTER
Dear Mr. Greither:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.florahealth.com/us from March-May 2021, and has determined that you take orders there for the products Travel Care Probiotic, Sleep•Essence, Cardio•Essence, Grape Seed Extract Plus, Elderberry+, Elderberry Crystals, Flor•Essence, Hydro-Therm Pumpkin Oil, Pumpkin Oil, and Mãnuka Honey. In addition, we observed that the product Elderberry+ is intended to mitigate, prevent, treat, diagnose, or cure COVID-19
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in people. We have also reviewed your social media website at https://www.pinterest.com/florahealth/, which directs consumers to your website at http://www.florahealth.com/us 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 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:
Travel Care Probiotic
On the Travel Care Probiotic webpage, as found on your, http://www.florahealth.com/us, website, under the Description:
 “Flora’s Travel Care Probiotic is a clinically proven…probiotic that’s been shown to help reduce incidence of traveler’s diarrhea and antibiotic-associated diarrhea while combating pathogenic “bad” bacteria…”
 “Reduces the risk of traveler’s diarrhea…”
 “Helps to reduce the risk of antibiotic-associated diarrhea…”
Additionally, similar claims were found on the webpage, Flora Products Insights: Shelf-Stable Products, on your website, http://www.florahealth.com/us, and on your Pinterest social media page, https://www.pinterest.com/florahealth/.
Sleep•Essence
(labeled as containing, among other ingredients, chamomile flower and lavender flower)
As found on the webpage, The Sleep-Stress-Immunity Connection, on your website, http://www.florahealth.com/us:
 “Sleep-Essence…can help in cases of…insomnia due to mental stress.”
As found on the webpage, Sleep and Cleansing, on your website, http://www.florahealth.com/us:
 “[Sleep•Essence] also relieves anxiety…”
 “Sleep•Essence makes for a delicious formula to help you relive insomnia…and anxiety...”
As found on the Herb Encyclopedia webpage for Chamomile, on your website, http://www.florahealth.com/us:
 “Chamomile was the subject of a 2009 study for its benefit in cases of…anxiety. This randomized, double-blind, placebo-controlled study found that chamomile extract had a significant effect over placebo in reducing anxiety scores after 8 weeks of use for people with mild to moderate anxiety.”
 “Through its bitter properties and essential oil, chamomile also increases the flow of gastric juices relieving dyspepsia, indigestion, heartburn, and other gastrointestinal complaints including: gastritis, enteritis, colitis…”
 “Chamomile tea is also recommended…to treat headaches…”
 “For nervous indigestion…; for inflammatory conditions of the GI tract; for… insomnia; anti-inflammatory and antimicrobial.”
 Amsterdam JD, et al. A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder. J Clin Psychopharmacol. 2009 Aug;29(4):378-82.
As found on the Herb Encyclopedia webpage for Lavender, on your website, http://www.florahealth.com/us:
 “Lavender oil can also be used as a local anesthetic…”
 “[F]or anxiety and insomnia; for indigestion ...”
Cardio•Essence
(labeled as containing, among other ingredients, hawthorn blossom and leaf)
As found on the webpage, The Link Between Cardio, Respiratory and Immune Health, on your website, http://www.florahealth.com/us:
 “Hawthorn…protects against heart damage, and protects against heart arrhythmias. Hawthorn is also able to strengthen and protect blood vessels from oxidative damage and plaque buildup.”
As found on the webpage, Keep Your Heart Healthy with Cardio-Essence, on your website, http://www.florahealth.com/us:
 “For increased blood flow to the heart, congestive heart failure (CHF), chest pain, and irregular heartbeat, ‘hardening of the arteries’ (atherosclerosis), and high cholesterol, studies…have shown hawthorn is your real BFF…”
 “Hawthorn also seems to have blood pressure-lowering properties.”
 “Research also suggests that hawthorn can lower cholesterol, low-density lipoprotein (LDL, or “bad cholesterol”), and triglycerides (fats in the blood).”
Grape Seed Extract Plus
On the Grape Seed Extract Plus webpage, as found at your, http://www.florahealth.com/us, website, under the Suggested Use:
 “Adults:…To relieve symptoms related to non-complicated CVI…”
Elderberry +
(labeled as containing organic black elderberry juice crystals, echinacea purpurea, and licorice root)
As found on the webpage, Elderberry and the SARS-CoV-2 Virus, on your website, http://www.florahealth.com/us:
 The name of the page implies that elderberry is effective in preventing and/or treating COVID-19, the illness resulting from SARS-CoV-2.
 “Elderberry has been shown in research to interfere with influenza viruses…[I]t is effective at reducing upper respiratory symptoms due to cold and flu.”
 “Elderberry has…laxative…and antiviral effects. Research has shown that it is effective against influenza A, B, and H1N1 variants. Elderberry contains a variety of compounds that support immune health. These include a variety of polyphenols, like anthocyanins, that bind with viruses to prevent them from attacking healthy cells, while also strengthening and protecting cell membranes to prevent viral penetration.”
 “[O]ne study has already shown that elderberry can…reduce inflammation…”
As found on the webpage, Immunity- It Works A Lot Like Teamwork, on your website, http://www.florahealth.com/us:

“Why Elderberry, Echinacea, and Licorice?”
o “…The three herbs work together on a deep level to enhance and modulate immune health, prevent infections, attack invading infections, and stop infections from spreading.”
o “Elderberry & echinacea…have been shown to be as effective as the leading flu drug, without the adverse events associated with that drug. Together with licorice, they have been shown to ease initial symptoms like sore throat and fatigue, reduce symptom duration and severity of seasonal illnesses if infected.”
o “…[T]hey interfere with seasonal viruses so they cannot easily take root and spread, and they reduce the overall severity and duration of infections.”

“Are These Plants Really That Helpful?”
o “…[P]lants like elderberry and echinacea are truly powerful against viruses, and in many cases, safer than other alternatives. A meta-analysis that studied the effects of elderberry concluded that it could reduce the symptoms of upper respiratory tract…infections, and other studies have concluded that elderberry could reduce cold severity and duration.”
o “Another study published in Current Therapeutic Research recruited 473 patients…in the beginning stages of the flu and divided them into groups-one receiving an echinacea-elderberry formulation, and the other, the gold standard pharmaceutical treatment for influenza…The folks getting echinacea and elderberry fared slightly better than the drug group, with none of the adverse events.”

“How it Works- Herbal Teamwork Helps You Stay Healthy.”
o “
Echinacea purpurea
works preventatively…by stimulating the body’s innate immune response. This helps to reduce the chance of catching a cold or flu. Echinacea and licorice can have a direct effect against infections of the upper respiratory tract, inhibiting influenza and rhinoviruses, and certain coronavirus strains. Both elderberry and echinacea have been trialed in airline passengers and shown to reduce our chances of catching colds and other respiratory illnesses.”
o “Elderberry flushes the body while increasing secretory IgA levels, which can be effective against A, B…, and H1N1 variants of influenza.”
o “Even if the viruses do attach, elderberry strengthens our cell membranes to make it really tough for viruses to penetrate, while echinacea inhibits the hyaluronidase that some pathogens use to breakthrough. Finally, if you do get a mild case of something, elderberry can slow viral replication. Then echinacea helps to repair tissue and cells damaged by infection and reverses excess mucus, and licorice acts as a soothing expectorant to mobilize stubborn mucus from airways and relieve sore throats and coughs.”

“Are Cytokines an Issue?”
o “…[E]lderberry also has anti-inflammatory…properties…”
o “…[E]chinacea reverses excess inflammatory cytokine response…”
Elderberry Crystals
As found on the webpage, Fight Against Flu Season With an Easy Elderberry Brekkie Bowl, on your website, http://www.florahealth.com/us:
 “Elderberry has been used in traditional medicine for millennia for a variety of ailments, from burns to infections.”
 “[E]lderberry extract may…reduce the length and severity of cold and flu symptoms.”
Flor•Essence
As found on the webpage, Herbal Wisdom and the 8 Great Herbs in Flor•Essence (identified as burdock root, sheep sorrel, slippery elm bark, rhubarb root, red clover, blessed thistle, watercress, and kelp), on your website, http://www.florahealth.com/us:
Burdock Root
 “Burdock is such a powerful detoxifier, it is used for the treatment of skin conditions that result in dry, scaly patches, such as psoriasis and eczema.”
 “[A]cts as an immune modulator, likely because it has antifungal properties and contains antibiotic substances called polyacetylenes.”
Sheep Sorrel
 “Sheep sorrel also has antibacterial and antiseptic properties and is closely related to species that contain rumicin, a powerful compound effective against E. coli, Staph, and Salmonella bacteria.”
 “[S]heep sorrel has been traditionally used to cool fevers and decrease inflammation…”
Slippery elm bark
 “Slippery elm bark is anti-inflammatory, demulcent…”
 “It gives relief from diarrhea…”
Turkish Rhubarb
 “Rhubarb root has anti-inflammatory, antispasmodic, vasorelaxant, [and] viricidal…properties. It is… considered the primary treatment for dysentery…”
 “[I]t not only cleanses the intestinal tract but also…disinfects.”
 “[I]t also contains emodin, which is antimicrobial…”
Red Clover
 “Red clover contains antimicrobial compounds that are effective against bacteria, viruses, and fungi.”
 “It also…anti-inflammatory, anti-allergy…”
 “It…has been used in the treatment of skin diseases…”
Blessed Thistle
 “[C]ontains anti-inflammatory cnicin…”
 “…[H]elpful in the treatment of dyspepsia and digestive pains and even the headaches associated with liver conditions.”
 “Blessed thistle is…antibacterial, showing effects against Staphylococcus aureus and S. faecalis bacteria.”
Watercress
 “[H]as therapeutic value for the treatment of…rheumatism, and bronchitis.”
Kelp
 “Kelp is also therapeutic for the…regulation of blood pressure and may help to lower cholesterol levels.”
Hydro-Therm Pumpkin Oil and Pumpkin Oil (labeled as containing pumpkin seed oil)
As found on the webpage, Pumpkin seed oil, a safe, food-based way to promote prostate health, on your website, http://www.florahealth.com/us:
 “Cucurbita pepo, as pumpkin is officially known, may help with…prostate enlargement, and reduce symptoms that can otherwise negatively affect quality of life.”
 “[I]t is thought that pumpkin seeds can play a role in supporting prostate health and relieving benign prostate hyperplasia (BPH).”
 “[E]ven a small amount of pumpkin oil can help with lower urinary tract symptoms… related to enlargement of the prostate, there is also at least one study that has found pumpkin seed oil helpful in general cases of overactive bladder...”
 “Pumpkin seed oil may contain over a dozen sterols…”
 “These sterols are potentially helpful for symptoms of BPH, or benign prostatic hyperplasia…”
 “The reddish carotenoid pigments in the [pumpkin] oil may also play an important role in lowering the risk of BPH.”
Mãnuka Honey
As found on the webpages, honey let’s bee real, on your website, http://www.florahealth.com/us:
 “The native mãnuka tree…traditionally used…as an antimicrobial, anti-inflammatory…”
 “MGO was a key ingredient responsible for the antibacterial effect of the honey…”
 “Case studies have shown positive results for clearing infections.”
 “Cell studies have found that it can inhibit a wide range of pathogens…prevent and eradicate biofilms, and work in synergy with antibiotics.”
 “Especially valuable when it comes to the issue of antibiotic resistant bacteria.”
Your Travel Care Probiotic, Sleep•Essence, Cardio•Essence, Grape Seed Extract Plus, Elderberry+, Elderberry Crystals, Flor•Essence, Hydro-Therm Pumpkin Oil, Pumpkin Oil, and Mãnuka Honey 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 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 Sleep•Essence, Cardio•Essence, Elderberry+, Elderberry Crystals, Flor•Essence, Hydro-Therm Pumpkin Oil, and Pumpkin Oil 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, Sleep•Essence, Cardio•Essence, Elderberry+, Elderberry Crystals, Flor•Essence, Hydro-Therm Pumpkin Oil, and Pumpkin Oil 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 review of your website and products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You should take prompt action to address the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and any other violations. Failure to promptly address the matters specified above may result in legal action without further notice, including, without limitation, seizure of violative products and/or injunction.
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address the above matters. 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 addressing these violations 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 U.S Food and Drug Administration, Attention: Amy R. Glynn, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have any questions regarding this letter, please contact Compliance Officer Glynn at 425-302-0411.
Sincerely,
/S/
Miriam R. Burbach
District Director
Program Division Director
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There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell a product that is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Content current as of:
06/29/2021
Regulated Product(s)
Drugs
Food & Beverages