WARNING LETTER
Get The Tea
MARCS-CMS 538965 —
March 22, 2018
Recipient:
Get The Tea
United States
Issuing Office:
Denver District Office
United States
Denver District Office
6th Ave & Kipling St, Bldg 20 DFC
PO Box 25087
Denver, CO 80225-0087
March 22, 2018
WARNING LETTER
Via UPS Overnight
Mr. Ronald K. McMullen, Co-Owner and President
Get The Tea
781 Airpark Way Ste A1
Cottonwood, AZ 86326-4090
Ref #: HAF4W(DEN)-18-06-WL
Dear Mr. McMullen:
From September 14, 2017, through September 15, 2017, an investigator from the U.S. Food and Drug Administration (FDA or we) conducted an inspection of your facility located at 781 Airpark Way Ste A1, Cottonwood, Arizona. During the inspection our investigators identified significant violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulations, Title 21 Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
We have also reviewed your website at www.getthetea.com in March 2018 and determined that you take order there for the products Allicin Advanced, Ceylon Cinnamon, Life Change Power Cleanse, Life Change Tea Super Strength, Life Change Tea Regular Strength, Eighth Element, G.I. Joy, Wild Alaska Sockeye Omegas, Hawthorn Berry Syrup, PotentSea Marine Aminos, Ocean Sleep, Tea Tree Lavender Balm, and Wildflower West Sun Damage Serum. Additionally, we have reviewed the product labels for these products. The claims on your product labels and website establish that the products are drugs under section 201(g)(1)(B) and/or (g)(1)(C) of the Act [21 U.S.C. 321(g)(1)(B) and/or (g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease, and/or 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.
We have also reviewed the labeling for your Life Change Tea Super Strength, Moringa Leaf capsules, Moringa Extract, Grapeseed Extract, Ceylon Cinnamon, and Astaxanthin Max, including product labels and your website www.getthetea.com. Based on our review, we have concluded that your products are in violation of section 403 of the Act [21 U.S.C. 343] and its regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101.
You can find the Act and FDA regulations through links on FDA’s website
www.fda.gov
.
Unapproved New Drugs and Misbranded Drugs
Examples of some of the claims that provide evidence that your Allicin Advanced, Ceylon Cinnamon, Life Change Power Cleanse, Life Change Tea Super Strength, Life Change Tea Regular Strength, Eighth Element, G.I. Joy, Wild Alaska Sockeye Omegas, Hawthorn Berry Syrup, PotentSea Marine Aminos, Ocean Sleep, Tea Tree Lavender Balm, and Wildflower West Sun Damage Serum are intended for use as drugs include:
Life Change Tea Super Strength
Website:
“This special formula helps support people with problems such as . . . nausea and constipation.”
“Detoxify: Parasites, Bacteria, & Toxins Reduce: Constipation, Acid Reflux & Indigestion”
Product label:
“Reduce constipation”
Allicin Advanced
Website:
“Allicin is known as ‘Nature’s antibiotic’”
“[H]elps with mild depression”
Ceylon/Cinnamon
Website:
“Joint Support: Cinnamon’s ability to lower the release of arachidonic acid from cell membranes also puts it in the category of an ‘anti-inflammatory’ . . .”
Life Change Power Cleanse
Website:
“Remove All: Parasites, Bacteria, & Toxins”
Life Change Tea Regular Strength
Website:
“Detoxify: Parasites, Bacteria, & Toxins”
“Reduce: Constipation, Acid Reflux & Indigestion”
“Blessed Thistle  [an ingredient in the product]: Blessed thistles has been recorded . . . for treating smallpox, fever, anorexia, dyspepsia, indigestion, constipation . . . . [H]as been shown to be useful in: Indigestion, heartburn . . . . [U]sed possibly to treat cancer as well as infections, heart and liver ailments and fevers.”
“Holy Thistle  [an ingredient in the product] has been used . . . for liver and gallbladder disorders.”
“Malva Leaf [an ingredient in the product]: . . . The seeds are . . . used in the treatment of renal disorders . . .”
“Marshmallow Root/Leaf  [an ingredient in the product]:  . . . helpful for symptomatic [sic] relief of coughs and irritate throats. Mallow has expectorant and demulcent properties, which accounts for this herb’s historical use as a remedy for . . . bronchial congestion . . . . [M]arshmallow has been used to treat sore throats and to alleviate heartburn. Marshmallow may also have mild anti-infective . . . properties.”
“Persimmon Leaf [an ingredient in the product]: An allergy preventive or itching preventive food . . . Cure allergies and hay fever now. No need for antihistamines.”
“Sarsaparilla  [an ingredient in the product]: Leaves and stems provide a cure-all and a general tonic reputed to relieve colds, flu, coughs, bronchitis, arthritis, rheumatism and diabetes. The new leaves can be sucked to ease a sore throat . . . . It cures internal pains like bellyache . . . . [S]ome people have been using it for cancers.’ . . .  It has also proven to be an anti-inflammatory, antirheumatic, heals scabies, anti spasmodic, cures syphilis . . . .”
Eighth Element
Website:
Your website describes Eighth Element as “[t]he most powerful Cordycep product available. . . . Cordyceps is a family of mushrooms with fascinating bioactive properties. They all live in extremely harsh environments and have evolved a complex chemistry that is found nowhere else in nature. This complex chemistry has been found to have many health-giving properties for humans. An example of these beneficial compounds are Deoxy-nucleosides – DNA-like structures that insert themselves into DNA and interrupt the synthesis of aberrant cells.”
G.I. Joy
Website:
“Benefits of Aloe  [an ingredient in the product]: . . . It is best known for treating skin injuries . . . . Helps reduce dental plaque. Helps reduce constipation. It is said to enhance insulin sensitivity and help improve blood sugar management.”
“Benefits of Peppermint  [an ingredient in the product]: . . . Peppermint was used in folk medicine as a pain reliever. Its value as a gastric stimulant and antibacterial agent are being revisited by modern medicine. . . . May be used to aid in the relief of pain from mild tension headaches.”
Wild Alaskan Sockeye Omegas
Website:
“The U.S. military has started to provide sockeye salmon oil to returning vets as a way to help with depression and PTSD.”
“HELPS WITH MILD DEPRESSION”
Hawthorn Berry Heart Syrup
Website:
“Also used to treat leakage of the heart . . . lesions left by former heart attacks . . . cardiac dropsy, hypertrophy and other functional and congenital heart disorders. There are several hundred types of heart diseases known to the medical profession, but the good thing about hawthorn berry syrup is that it will heal all of them. Studies show that hawthorn exert a relaxing effect on the arteries, consequently enhancing blood circulation and blood pressure. Flavonoid compounds in hawthorn were also found to regulate the effect of ACE (angiotensin converting enzyme). ACE influences the blood pressure by constricting the blood vessels – which narrows the pathway of blood increasing blood pressure. Hawthorn’s antioxidant flavonoids naturally regulate the ACE effect, thereby demonstrating better heart and kidney health in patients at risk.”
PotentSea® Marine Aminos
Website:
“Fight
… Epstein Barr”
Ocean Sleep
Website:
“At least 40 million Americans each year suffer from long-term sleep disorders . . . . Ocean Sleep’s breakthrough new ingredient RegalusTM provides you with an all-natural sleep solution . . . .”
Tea Tree Lavender Balm
Website:
“All Natural Antiseptic, Anti-Fungal and Anti-Bacterial”
“Excellent for Eczema, Athlete’s Foot, Diaper Rash”
“Tea tree oil can help relieve any type of skin inflammation, including being used as a natural eczema treatment and for reducing psoriasis. It is considered one of the most effective home remedies for acne. Because of its ability to kill parasites and fungal infections, tea tree oil is a great choice to use on fungus, athlete’s foot and ringworm.”
“[H]elps kill MRSA and staph infections.”
“LAVENDER OIL [an ingredient in the product]: Treats various skin disorders like acne, psoriasis, eczema and wrinkles. It also helps form scar tissues (sic), which may be essential in healing wounds, cuts and burns.”
Wildflower West Sun Damage Serum
Website:
“[I]ntensely detoxifies skin, minimizing the appearance of sun damage discolorations, tumors, rashes, adult acne eruptions and chemical burns . . . .”
“[H]elps remove skin tumors and precancerous growths, especially actinic keratosis.”
“[S]trongly antimicrobial, purifying and protecting skin, minimizing breakouts and viral cold sores.”
“[H]elps skin regulate melanin production”
“[I]mmune boosting and anti-inflammatory”
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Life Change Tea products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
“I’ve been detoxing with LCT for a few years now and it ALWAYS works!!! This Easter I got an acute double tonsillitis infection which swelled my glands, my entire throat, my tongue and even my gums. For months afterwards my teeth HURT and I knew I had to cleanse in order to get rid of the infection. I did the cleanse and within the 1st week I started to see incredible results. The swelling in my gums went down and the constant tooth pain has now pretty well vanished and it’s only been 2 & ½ weeks. My glands are finally clean & pain free . . . .”
“I have been on the
Life Change Tea Super Strength Tea
for six months now. In the six months of being on the tea, all of my digestive problems have cleared up . . . and constipation problems are no more.”
“The Life Change Tea really brought me out of the last bit of depression . . . .”
“I want to thank you for your tea. I have been suffering from a pain that several doctors could not figure out. I knew it had something to do with my constipation, but couldn’t get any of them to listen to me . . . . I am now 100% off the Mira-Lax and the pills the Dr’s put me on and am only drinking my tea.”
“I went ahead and ordered the Super Strength Tea and already with my second day and 32 ounces of tea in my system, my diverticular bleed has almost completely stopped . . .”
“I’m a returning new customer; actually just ran out of my first order of Life Change Tea. And, I’ve been telling friends and co-workers that I haven’t felt this good in a long time. For a number of months I was feeling a lot of pressure from kidney stones; and within just a few days after I started taking the tea, I have no more pain.”
“Doctor’s [sic] have said that my colon would never work again. My colon is working perfectly thanks to Life Change Tea!”
“My husband is getting rid of a lot of the parasites from using the tea.”
“I had suffered from years of low energy levels, along with chronic migraines, headaches and various problems including aches and pains. Now today– after being on the Super Tea and the Power Cleanse (once a year) for two years – I feel good! No more headaches, no more migraines . . . .”
“[M]y husband is a diabetic, and was diagnosed with bladder cancer. Since being on the Power Cleanse and Super Tea, coupled with added vitamins and a proper diet, he was given a clean bill of health from his doctor. We believe he is healthy because the tea and cleanse helped him. His diabetes and high blood pressure remain in check and under control today, because he takes your products everyday . . . .”
“I first started the tea in late December 2008, and I haven’t had any colds or long sickness since. There have been two times, each lasting about 8 hours, I had some kind of flu that was really bad . . . and I always get well . . . Life Change Tea helps stop these attacks quicker . . . .”
“[M]y liver was a little messed up–but because I’ve been taking the tea, my liver count is back up to normal.”
“[A]fter taking Life Change Super Strength Tea and changing my diet, I’ve had a real turn around with my diabetes. When I went back to my doctor, his jaw dropped at the results. So I’m staying on the Super Tea and the diet change . . . and no insulin!”
Your Allicin Advanced, Ceylon Cinnamon, Life Change Power Cleanse, Life Change Tea Super Strength, Life Change Tea Regular Strength, Eighth Element, G.I. Joy, Wild Alaska Sockeye Omegas, Hawthorn Berry Syrup, PotentSea Marine Aminos, Ocean Sleep, Tea Tree Lavender Balm, and Wildflower West Sun Damage Serum 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)]. 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 Life Change Tea Super Strength, Allicin Advanced, Life Change Tea Regular Strength, Wild Alaskan Sockeye Omegas, Hawthorn Berry Heart Syrup, PotentSea Marine Aminos, Tea Tree Lavender Balm, and Wildflower West Sun Damage Serum 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, these 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)].
Dietary Supplement CGMP Violations
During the inspection of your facility, our investigator observed the following significant violations of CGMP requirements for dietary supplements, which render your dietary supplement products adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]. Additionally, even if your product labeling did not contain claims that render your Ceylon Cinnamon product an unapproved new drug, your Ceylon Cinnamon would be an adulterated dietary supplement for the following reasons:
1.
You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. Specifically, you do not have any written quality control procedures.
As a distributor that contracts with a manufacturer to manufacture, package, and label dietary supplements on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements. In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. §§ 342(g) and 331(a)]. Thus, a firm that contracts out some or all its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55).
Furthermore, you receive finished, packaged and labeled dietary supplements from contract manufacturers that manufacture the dietary supplements on your behalf, which you hold and distribute into interstate commerce. As such, the quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105), and you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2)).
We note that during the inspection you stated that the contract manufacturer tests
(b)(4)
finished product and that certificates of analysis (COAs) are available upon request for
(b)(4)
of finished product. You provided copies of product COAs for Get the Tea Astaxanthin Max, Get the Tea Colostrum Complete, and Get the Tea Pine Bark Capsules to our investigator. Upon review of these COAs it was noted that the COAs only include tests for microbiological contamination in the finished batch of the dietary supplements. The COAs do not include verification that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, and composition to ensure the quality of the dietary supplement. Therefore, such COAs would not provide an adequate basis upon which your quality control personnel could rely on for approval for release of any packaged and labeled dietary supplement for distribution (21 CFR 111.127(h)).
We also note that during the inspection you did not have copies of finished product specifications used to approve for release, or reject, your packaged and labeled dietary supplement for distribution. Without any such documentation, it is unclear on what basis your quality control personnel could evaluate whether finished product specifications are met.
We have reviewed your response dated September 20, 2017, in which you state you will have all documents in place for your next inspection. We are unable to evaluate the adequacy of your corrective actions because you have provided no supporting documentation for our review.
2.
You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you have no written procedures for the review and investigation of product complaints, nor do you have records documenting the complaints you have received, your response, or any investigation which may have been performed. Once you establish the necessary written procedures, you must make and keep written records of every product complaint that is related to good manufacturing practice for the review and investigation of product complaints, in accordance with 21 CFR 111.570(b)(2).
We have reviewed your response dated September 20, 2017, which states you will have documentation of corrective actions in place for your next inspection. We are unable to evaluate the adequacy of your corrective actions because you have provided no supporting documentation for our review.
3.
You failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. Specifically, you have not established written procedures for returned dietary supplements relating to any of the dietary supplement products you distribute. Once you establish such written procedures, you must make and keep records of the dietary supplements that are returned and the disposition of those products, as required by 21 CFR 111.535(b)(2).
We have reviewed your response dated September 20, 2017, which states you will keep written documentation of future returns. We are unable to evaluate the adequacy of your corrective actions because you have provided no supporting documentation for our review, such as a written procedure for returns, or a log or other record showing implementation of your revised practice.
4.
You failed to establish and follow written procedures for holding and distribution operations, as required by 21 CFR 111.453. Specifically, you have not established written procedures for holding and distributing operations.
We have reviewed your response dated September 20, 2017, which states this will change immediately. We are unable to evaluate the adequacy of your corrective action because you have provided no documentation for our review.
Misbranded Dietary Supplements
Your Grapeseed Extract, Moringa Extract, Moringa Leaf, and Astaxanthin Max capsules are misbranded under section 403 of the Act [21 U.S.C. § 343]. Additionally, even if your product labeling did not contain claims that render the product an unapproved new drug, your Ceylon Cinnamon product would be misbranded under section 403 of the Act [21 U.S.C. § 343], as follows:
1.    Your Ceylon Cinnamon, Grapeseed Extract, Moringa Extract, Moringa Leaf capsules, and Astaxanthin Max products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labeling bears nutrient content claims, but the products do not meet the requirements to bear such claims.
Nutrient content claims using the term “antioxidant” must comply with 21 CFR 101.54(g). These requirements state, in relevant part, that for a product to bear such a claim, a reference daily intake (RDI) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(g)(1)]; that these nutrients must have recognized antioxidant activity [21 CFR 101.54(g)(2)]; that the level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e) [21 CFR 101.54(g)(3)]; and that nutrient content claims using the term "antioxidant" must include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term "antioxidant" or "antioxidants" may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label followed by the name or names of the nutrients with recognized antioxidant activity [21 CFR 101.54(g)(4)].
Your labeling bears the following claims:
a.
Your Grapeseed Extract product label contains the claim “Antioxidant-Rich Support for Well-Being,” and your website getthetea.com includes the following claims for the product: “Contains Powerful Antioxidants” and “Grape seed extract has an incredible antioxidant potential.”
b.
The getthetea.com webpage for the Ceylon Cinnamon product contains the following claims: “Cinnamon is loaded with antioxidants” and “Powerful Antioxidant.”
c.
The getthetea.com webpages for both your Moringa Leaf capsules and your Moringa Extract products contain the claim, “Moringa Oleifera is, without question, nature’s most Nutritious, antioxidant-rich superfood!”
d.
Your Astaxanthin Max label bears the statement, “The Most Potent Antioxidant Blend In the World,” and the product webpage lists the following claims: “Extraordinarily potent antioxidant properties,” “Astaxanthin’s antioxidant power is up to 550 times stronger than vitamin E and 10 times more potent than beta-carotene,” and “Vitamin C: A strong antioxidant.”
For each of these products, neither your product label nor website, as applicable, identify the nutrients that are the subject of the claims [21 CFR 101.54(g)(4)]. Further, grapeseed extract, Ceylon cinnamon, and moringa leaf are not nutrients with established RDIs. According to the product label, your Astaxanthin Max product contains antioxidants that have established RDIs, but the product label and your website fail to identify which of its antioxidants are the subject(s) of the claims.
2.    Your Ceylon Cinnamon, Astaxanthin Max, Grapeseed Extract, Moringa Extract, and Moringa Leaf capsules dietary supplement products are misbranded within the meaning of section 403(q) of the Act (21 U.S.C. 343(q)) in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.9 and/or 21 CFR 101.36. For example:
a.  The Astaxanthin Max label lists Vitamin B12 and Vitamin C within the Supplement Facts label as part of a proprietary blend. Since they are listed as part of the proprietary blend, it appears that the ingredients are added to the product for the purposes of supplementation. These ingredients have recommended daily intakes (RDIs), and as such are referred to as “(b)(2)” dietary ingredients, 21 CFR 101.36(b)(2). As a result, they cannot be declared as part of the proprietary blend, and their amounts in the product must be declared when they are present in the product in an amount by weight that exceeds the amount that can be declared as zero in nutrition labeling of foods, in accordance with 21 CFR 101.9(c). Their declaration must be separated from the declaration of the dietary ingredients in the proprietary blend (“(b)(3)” dietary ingredients, which have no RDI or DRV, by means of a heavy bar, in accordance with 21 CFR 101.36(b)(2) & (3), 21 CFR 101.36(c)(1), and 101.36(e).
b.  Your Grapeseed Extract product’s webpage contains the claim, “Grape Seeds contain high levels of vitamin A & E,” and the Ceylon Cinnamon product’s webpage contains the claim, “Excellent source of Fiber and Trace Mineral Manganese.” Under 21 CFR 101.54(b)(1), the claims “high” and “excellent source of” mean that the dietary supplement contains 20 percent or more of the RDI or DRV per reference amount customarily consumed. It is unclear whether you satisfy the requirement to make such a claim, but even if you do, your products do not meet the requirements of 21 CFR 101.36(b)(2)(i) because your Grapeseed Extract product does not include information about vitamins A and E, and your Ceylon Cinnamon product does not including information about dietary fiber and manganese. Under 21 CFR 101.36(b)(2)(i), the amount of dietary fiber shall be declared when it is present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero, and the amount of vitamins or minerals listed in 21 CFR 101.9(c)(8)(iv) (which include Vitamin A, Vitamin E, and Manganese)) must be declared when a claim is made about them.
c.  Your Moringa Extract label fails to list the quantitative amount of the dietary ingredient
Moringa oleifera
, in accordance with 21 CFR 101.36(b)(3).
d.  Your Moringa Extract label lists zero grams of sugar, which is a (b)(2) dietary ingredient. Any (b)(2) dietary ingredients must not be declared if they are not present or are present in amounts that can be declared as zero in 21 CFR 101.9(c), in accordance with 21 CFR 101.36(b)(2).
e.  Your Moringa Extract label lists Amount Per Teaspoon, but the serving size is ¼ tsp. The nutrition information must be presented for the Amount Per Serving, in accordance with 21 CFR 101.36(b)(2)(i)(A).
f.  Your Moringa Extract label declares a % Daily Value for calories, for which a DRV or RDI has not been established. Such a declaration is not in accordance with 21 CFR 101.36(b)(2)(iii).
g.
Your Astaxanthin Max product labeling makes a claims that suggests the product contains vitamin E, “Astaxanthin’s antioxidant power is up to 550 times stronger than vitamin E .” Your Moringa Leaf capsule and Moringa Extract product labeling makes claims that suggest the product contains zinc and iron, and your website getthetea.com makes a claim that suggests that your Ceylon Cinnamon product contains calcium, ”. . . a very good source of calcium.” However, the products’ Supplement Facts labels fail to declare these dietary ingredients in accordance with 21 CFR 101.36(b)(2).
A dietary ingredient, which has a Reference Daily Intake (RDI) or Daily Reference Value (DRV) as established in 101.9(c) (hereinafter referred to as “(b)(2)-dietary ingredient”), that is required to be declared in labeling must be declared when present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods (21 CFR 101.36(b)(2)(i)). Other vitamins or minerals listed in 21 CFR 101.9(c)(8)(iv) or (c)(9) must be declared if added for purposes of supplementation, or when a claim is made about them. Id. Any (b)(2)-dietary ingredients that are not present or that are present in amounts that can be declared as zero in 101.9(c) must not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). Id.
We consider the above statements to subject these products to the requirements of 21 CFR 101.36(b)(2)(i) that require mandatory vitamins and minerals to be declared and certain other vitamins and minerals to be declared if added for purposes of supplementation or when a claim is made about them. However, we note the Supplement Facts labels do not list the nutrients listed in the statements above.
h.
Your website getthetea.com makes statements for your Moringa Leaf capsule and Moringa Extract products, “Moringa contains gram for gram: 7 times the vitamin C in oranges…4 times the vitamin A in carrots…4 times calcium [sic] in milk…3 times the potassium in bananas…2 times the protein in yogurt.”
A (b)(2)-dietary ingredient that is required to be declared in labeling must be declared when present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods (21 CFR 101.36(b)(2)(i)). Other vitamins or minerals listed in 21 CFR 101.9(c)(8)(iv) or (c)(9) must be declared if added for purposes of supplementation, or when a claim is made about them. Id. Any (b)(2)-dietary ingredients that are not present or that are present in amounts that can be declared as zero in 101.9(c) must not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). Id.
We consider the statements such as, “Moringa contains gram for gram: 7 times the vitamin C in oranges…4 times the vitamin A in carrots…4 times calcium [sic] in milk…3 times the potassium in bananas…2 times the protein in yogurt” to subject this product to the requirements of 21 CFR 101.36(b)(2)(i) that require mandatory vitamins and minerals to be declared and certain other vitamins and minerals to be declared if added for purposes of supplementation or when a claim is made about them. However, the Moringa Leaf capsule and Liquid Moringa Leaf Extract products’ Supplement Facts labels do not list the vitamins, minerals, or protein referenced in the statements.
Misbranded Foods
Even if your product labeling did not contain claims that render the product unapproved and misbranded drugs, your Life Change Tea Super Strength product would be misbranded under section 403 of the Act [21 U.S.C. § 343], as follows:
1.
Your Life Change Tea Super Strength product is misbranded within the meaning of section 403(q) of the Act (21 U.S.C. 343(q)) in that the presentation of the nutrition information on the labeling of the product does not comply with 21 CFR 101.9. For example, your Life Change Tea Super Strength Label:
Fails to declare the “Nutrition Facts” heading [21 CFR 101.9(d)(2)]
Fails to declare “Sodium” in accordance with 21 CFR 101.9(c)(4)
Fails to declare % DV for the nutrients (except for protein) as required by 21 CFR 101.9(d)(6)
Lists caffeine, which is not a required nutrient under 21 CFR 101.9(c). Therefore, it cannot be declared within the Nutrition Facts label.
We note that the product may qualify to use the simplified format since most nutrients are present at insignificant amounts [21 CFR 101.9(f)].
2.    Your Life Change Tea Super Strength product is misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that it fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or in connection with your products. It is your responsibility to ensure your establishment is in compliance with all applicable laws and regulations, including FDA requirements. You should take prompt measures to correct all violations described in this letter. Failure to do so may result in enforcement action by FDA without further notice, such as injunction or seizure.
Additionally, we have the following comment regarding your Moringa Leaf capsule and Moringa Extract products. We consider the statements described previously in this letter that the products have “[x] times the” nutrients in other foods to be nutrient content claims that the products have “more” of these nutrients than the other foods. To bear a “more” claim, the product must contain at least 10% more of the RDI for vitamins or minerals or of the DRV for protein per reference amount customarily consumed than an appropriate reference food [21 CFR 101.54(e)]. The claim may only be made if the product bears sufficient amounts of the nutrients to qualify to bear the claim, and the claim must be made in accordance with 21 CFR 101.54(e)(1) and 21 CFR 101.13(j), which contains requirements for identification of the reference food(s) and a quantitative comparison of the nutrients in the foods. Based on the lack of information pertaining to these nutrients, it is unclear whether your Moringa Lead capsule and Moringa Extract products satisfy the requirements to bear “more” claims.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Address your reply to the U.S. Food and Drug Administration; Attn: Hanna L. Potter, Compliance Officer; 6
th
Avenue & Kipling St, DFC – Bldg 20, P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Potter at (303)236-3094 if you have any questions about this matter.
Sincerely,
/S/
LaTonya M. Mitchell
District Director
Program Division Director
Office of Human and Animal Foods – Division IV West
Content current as of:
05/08/2018