RESPONSE LETTER
Absonutrix
- Company:
- Absonutrix
United States
- Recipient:
United States
Atlanta District Office | |
July 25, 2017
VIA UPS
Himanshu Nautiyal, Owner
Absonutrix, LLC
317 S. Westgate Drive
Suite J
Greensboro, NC 27407
WARNING LETTER
(17-ATL-09)
Dear Mr. Nautiyal:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.absonutrix.com in May of 2017 and has determined that you provide instructions there for ordering the products Absonutrix Forskolin Pure X-treme Capsules, Absonutrix Fucoidan Max Strength, Absonutrix Parasite Detox X-Treme, Absonutrix Lavender Oil X-Treme, Absonutrix Picamilon X-treme, Absonutrix Alpha GPC, Absonutrix Oil of Oregano X-Treme Purifier, Absonutrix Cissus X-Treme 1600 mg, Absonutrix Deep Comfort X-Treme, Absonutrix Deer Antler Maximum Strength, Absonutrix African Mango Max Strength, Absonutrix Cissus X-Treme, Absonutrix Phytoceramides, Absonutrix African Mango Pure, Absonutrix Acai Pure, Absonutrix Acai Burn X. Treme, Fucoxanthin Patch, and Forskolin Patch. The claims on your website establish that the products are drugs under section 201(g)(1)(B)and (C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B) and (C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or intended 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. 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:
Absonutrix Forskolin Pure X-treme Capsules
“When used in conjunction with Rolipram, Forskolin aids in the inhibition of colon cancer cell growth and survival. The combination of these two drugs is also useful…”
“Forskolin is a potent vasodilator and hence may help controlling high blood pressure…”
“Studies have indicated but not proved the beneficial effect of Forskolin in controlling the underlying cause of Glaucoma. The beneficial effect of reducing the intraocular pressure may be due to the property of forskolin…”
“Forskolin may also be effective in treatment of urinary tract infections...”
“Forskolin increases the skin resistance to burning under UV light…”
Absonutrix Fucoidan Max Strength
“Help regulate cholesterol and blood sugar levels…”
“Help fight the growth of tumors and help act as an anti-cancer agent...”
Absonutrix Parasite Detox X-Treme
“This product is unique in its composition and formulation because most of the ingredients used in it have proven anthelmintic effects…against parasites and disease...”
“Cranberry…to fight internal and external physiological parasites and diseases…strongly anti-coagulant and can aid in the removal of dental plaques and for the treatment of urinary tract diseases…Moreover, these tannins have strong anti-parasitic effects…acts as…anthelmintic agent...”
“Garlic is popular for its blood thinning properties. However, it has proven efficacy against parasites as well as viruses, bacteria, and fungus...”
“Black Walnut Hull Powder… causes irritation to the intestine and parasites, and especially worms that are attached to the walls of small and large intestines. With the help of Black Walnut hull Powder, these parasites can be expelled easier…”
“Papaya Fruit Powder… is very important in healing microscopic bruises and cuts in the intestinal track…to fight against parasites, viruses, and bacteria…”
“Pau D’Arco Powder…known to have toxic effects against bacteria, fungus and other parasites…”
“Cloves Powder...lead to the expulsion of worm in the feces. Moreover, it has a direct effect against parasites…”
“Wormwood Powder…has strong antimicrobial…anthelmintic effects. It is also used for the treatment of gastric pain...”
“Oregon Grape Root…is effective against bacteria and other parasites…used to treat infections of the skin...”
“Blueberry Leaf…known to help treat inflammation during the process of deworming…”
“Golden Thread…known by its anti-inflammatory and anthelmintic effects…”
“Goldenseal… has strong anthelmintic and anti-inflammatory effects…”
Absonutrix Lavender Oil X-Treme
“Helps Lower Blood Pressure”
“Absonutrix Lavender Oil X-Treme to help relieve many of the ailments…such as high blood pressure, aches & pains, and sleeping disorders.”
Absonutrix Oil of Oregano X-Treme Purifier
“These natural chemicals give Oregano Oil the ability to act as natural analgesic and anti-inflammatory agent.”
“More specifically, Absonutrix Oil of Oregano X-Treme Purifier can be used to help in protection against harmful organisms…skin infections...digestive problems…colds and sore throats.”
Absonutrix Cissus X-Treme 1600 mg
“HELPS REDUCE JOINT PAIN…rich in vitamin C which helps counter inflammation. Inflammation around joints is one of the factors which cause pain…”
“[A]n excellent tonic for pain relief due to, for example, broken bones or joint pains…analgesic properties…helps to reduce joint pain…”
Absonutrix Deep Comfort X-Treme
“HELPS PREVENT OSTEOARTHRITIS…”
Absonutrix Deer Antler Maximum Strength
“[H]elps reduce pains and aches…”
Absonutrix African Mango Max Strength
“Do you want to …lower your cholesterol?...essential to removing cholesterol…”
Absonutrix Picamilon X-treme
“High blood pressure, heart disease, digestive problems, and sleep problems have all shown a correlation to high stress and anxiety levels, and these can increase the risk of stroke, heart attacks, and several chronic illnesses...“
“[R]educed high blood pressure effects… can also lead to weakening of the arteries…”
Absonutrix Alpha GPC
“[T]o be a helpful dietary supplement for Alzheimerpatients and patients suffering from Dementia…”
Absonutrix Phytoceramides
“Phytoceramide supplements produced short-term results similar to Botox injections…”
Absonutrix Garcinia Cambogia
“[A] lower level of triglycerides and bad cholesterol (LDL)…”
“Garcinia Cambogia is a powerful natural blood sugar reducer that could cause an imbalance if taken along with chemical substances designed to reduce your blood sugars …”
Absonutrix African Mango Pure
“When it comes to lowering your cholesterol, detoxifying your body…”
“[T]o be a natural source of cholesterol management…”
“Green Tea Extract…widely accepted for its uses as an anti-carcinogen, anti-inflammatory…”
“Grapefruit powder can be used as a potent anti-microbial substance…”
Absonutrix Acai Pure
“Why are fatty acids and omegas important? Because research has shown that they lower both LDL...High cholesterol is responsible for numerous health-related issues, and it has been linked to strokes, heart attacks, coronary disease, high blood pressure and more…”
Absonutrix Acai Burn X-Treme
“[H]elps to reduce cholesterol levels in the blood…”
“Acai Fruits…In addition, studies in high-cholesterol-fed mice exhibit promising results on Acai fruits’ ability to reduce blood cholesterol levels in the body. Acai fruits dissolve excessive cholesterol present in the body…”
“Green Tea Extract…flavonoids present in this tea have strong anti-tumor…properties…”
“[T]reatment of…gastrointestinal parasites…”
“Grapefruit Powder…famous for reducing the cholesterol levels in the blood…”
Fucoxanthin Patch
“EXTREME FAT BURNER”
“Burns your unwanted Fat and Improves your Metabolic Rate…It contains three fantastic ingredients, all designed to help with weight management while also being healthy.”
Forskolin Patch
“Clinical studies has [sic] shown Forskolin’s role in increasing the lean mass, bone mass, and testosterone levels in the body. Forksolin also helps increase the metabolism of breaking-down fat. . . . Forskolin is a potent vasodilator and hence may help controlling high blood pressure and promoting heart health.”
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)]. 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 Absonutrix Forskolin Pure X-treme Capsules, Absonutrix Fucoidan Max Strength, Absonutrix Lavender Oil X-Treme, Absonutrix Picamilon X-treme, Absonutrix Alpha GPC 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, your products Absonutrix Forskolin Pure X-treme Capsules, Absonutrix Fucoidan Max Strength, Absonutrix Lavender Oil X-Treme, Absonutrix Picamilon X-treme, Absonutrix Alpha GPC 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)].
The above is not intended to be an all-inclusive list of violations in connection with your products or your firm. You should take prompt action to correct all noted violations. It is your responsibility to assure your firm complies with all requirements of federal law and FDA regulations. Failure to correct and prevent these violations or similar ones may result in legal action without further notice to you including, without limitation, seizure and injunction.
Further, we note that you display the FDA logo on your website, www.absonutrix.com. The FDA logo is for the official use of the FDA and not for use on private sector materials. To the public, such use would send a message that FDA favors or endorses a private sector organization or the organization’s activities, products, services, and/or personnel (either overtly or tacitly), which FDA does not and cannot do.
Please respond to this office in writing within 15 working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above noted violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the time within which you will complete the corrections.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. Morton at 404-253-1285 or write her at the noted address.
Sincerely,
/S/
Ingrid A. Zambrana
District Director
Office of Human and Animal Food Operations - Division 3 East
(Georgia – North Carolina – South Carolina)
Office of Regulatory Affairs
U.S. Food and Drug Administration
Cc: Atlanta District File (Absonutrix; Greensboro, NC; FEI: 3012107499)