WARNING LETTER
American Global Health Group, LLC
MARCS-CMS 610283 —
January 22, 2021
Delivery Method:
Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Jonathan Jewett
Recipient Title
Chief Executive Officer
American Global Health Group, LLC
11808 Northup Way, Suite W105
Bellevue
,
WA
98005
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
January 22, 2021
In reply, refer to CMS 610283
WARNING LETTER
Dear Mr. Jewett:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.aloecure.com in December 2020 and January 2021, and has determined that you take orders there for your AloeCure brand products including: AloeCure VeraFlex, AloeCure Advanced Formula Capsule, AloeCure Pure Aloe Vera Extract, and AloeCure Probiotic + Enzyme. We also reviewed your Facebook social media page at www.facebook.com/aloecure, which promotes your products and directs users to your website, www.aloecure.com, for purchase.
The claims on your website and Facebook page 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 and Facebook page claims that provide evidence that your products are intended for use as drugs include:
AloeCure VeraFlex
On the AloeCure VeraFlex webpage (https://www.aloecure.com/products/veraflex-healthy-joint):
• “Featuring A Clinically Proven Ingredient to Improve . . . Mobility, and Reduce Joint Discomfort”.
• “Increase mobility, reduce stiffness . . .”
• “Our research shows that joint stiffness, soreness and discomfort is caused by inflammation that attacks healthy cartilage and protective tissue. According to leading medical scientists, this inflammation is caused by two inflammatory enzymes released by the body’s own immune system . . . Remarkably, the active ingredients in VeraFlex help to block the production of both these critical enzymes, resulting in a dramatic decrease in discomfort.”
• “[A] recent study in the Journal of Nutrition and Metabolism shows the potential of these ingredients [in VeraFlex] to help the production of new liver, lung, and immune system cells that respond to fight infections”.
On the Facebook page at www.facebook.com/aloecure:
• “AloeCure’s VeraFlex features active ingredients that show improvement in joint stiffness in as few as 3 days and improved joint function within 7 days . . . ”
AloeCure Advanced Formula Capsule
On the AloeCure Advanced Formula Capsule webpage (https://www.aloecure.com/products/advanced-formula-capsule):
• “[D]elivers a concentrated formula of Aloe Vera to help neutralize bouts of acid reflux and heartburn while reducing inflammatory response . . .”
• “Scientifically proven natural acid buffer reduces stomach acid by up to 100x . . .”
On the Facebook page at www.facebook.com/aloecure:
• “[D]eliver a concentrated formula of Aloe Vera to help neutralize bouts of acid reflux and heartburn”.
• “[D]elivers fast acid buffering results with plenty of Acemannan, the primary active ingredient in aloe vera known for healing”.
AloeCure Pure Aloe Vera Extract
On the AloeCure Pure Aloe Vera Extract webpage (https://www.aloecure.com/products/pure-aloe-extract-aloe-juice):
• “Aloe Extract will coat your esophagus and calm your stomach. Once it contacts excess stomach acid, this soothing extract will neutralize it instantly”.
• “Buffers Stomach Acid on Contact”.
• “[A]cts as an acid buffer, improving pH regulation and overall digestive function enough to relieve discomfort . . . it's brimming with malic-calcium, a powerful acid blocker that quenches the awful burning sensation in your throat, esophagus, and stomach. It keeps the acid levels balanced to help flare ups from coming back . . . AloeCure also contains polysaccharides including the highest levels of acemannan, Aloe's famous healing property . . . delivers relief to cells scorched by excess acid and inflammation . . . Aloe is an immune system modulator which can improve and manage … inflammation.”
AloeCure Probiotic & Enzyme
On the AloeCure Probiotic & Enzyme webpage (https://www.aloecure.com/product/probiotic-enzyme):
• “Each AloeCure Probiotic + Enzyme capsule, provided by American Global Health Group, LLC, contains over two billion beneficial biorganisms . . . mixed in a base of digestive enzymes.”
• “There are varying degrees of enzyme deficiencies. At the extreme end of the spectrum is the inherited condition of cystic fibrosis, in which the enzymes needed to digest proteins, carbohydrates, and fats are either missing or are present in reduced amounts. Other severe conditions that are associated with enzyme deficiencies include pancreatic insufficiency, Celiac disease, and Crohn’s disease”.
On the same webpage, the following claims were made for Amylase, Protease, and Lipase, ingredients in AloeCure Probiotic & Enzyme:
• “A protease deficiency results in an alkaline excess in the blood . . . can cause anxiety and insomnia . . . [A] protease deficiency lays the foundation of arthritis, osteoporosis and other calcium deficient diseases”.
• “When you are low in amylase you are a candidate for abscesses. Amylase is also involved in anti-inflammatory reactions. An Amylase deficiency can result in skin problems such as psoriasis, eczema, hives, allergic reactions, atopic dermatitis, and all types of herpes. Asthma and emphysema may also be exacerbated by an amylase deficiency”.
• “Lipase deficient people have a tendency towards high cholesterol, high triglycerides, . . . and diabetes. Lipase deficient people also have decreased cell permeability, which can cause nutrient deficiencies within cells. Conditions such as vertigo or dizziness aggravated by movement can result from lipase deficiency.”
Also, your website at www.aloecure.com contains evidence of intended use in the form of personal testimonials recommending that the AloeCure products can cure, mitigate, treat, or prevent disease. Examples of these personal testimonials include:
AloeCure Pure Advanced Formula Capsule and AloeCure Pure Aloe Vera Extract (https://www.aloecure.com/products/advanced-formula-capsule/ and https://www.aloecure.com/products/pure-aloe-extract-aloe-juice/)
• “In 2007 I was introduced to AloeCure®. I've put AloeCure to the test and it works! AloeCure helps naturally balance the stomach pH levels, decrease the acidity feeling and prevent that burning sensation so many complain of due to stress, worry, or an unhealthy lifestyle. AloeCure is an all-natural solution that allows your body to heal itself.”
AloeCure VeraFlex (https://www.aloecure.com/products/veraflex-healthy-joint/)
• “I know first-hand the devastation of chronic pain and that restoration IS possible. While in medical school I developed rheumatoid arthritis, causing me to be wheelchair bound, potentially derailing my medical career . . . VeraFlex users can generally expect more flexibility in three days . . . their joint pain alleviated in five days . . . and in just seven days, a tremendous improvement in overall joint function. In my opinion, AloeCure has created the best supplement for joint health on the market and I recommend it to anyone looking for better mobility, reduced pain . . .”
• “I have used VeraFlex since October 2019 for chronic annoying sciatica type pain. I would be driving the car for 20 minutes and I have to shift my position because I really was getting sore in that area and ever since I started the VeraFlex I have not had that situation, it is totally resolved it and I take it once a day every day.”
• “Eight years ago I had an operation which resulted in losing 3 inches on one of my legs and that resulted in Joint pain. And over a period of years the pain got worse. And since I've taken VeraFlex I've had no knee pain at all.”
Additionally, the Blog tab of your website (https://blog.aloecure.com/blog/) contains evidence of intended use that the AloeCure products can cure, mitigate, treat, or prevent disease. Examples include the following blog posts:
• The article titled “5 Foods That Neutralize Stomach Acid” (https://blog.aloecure.com/blog/5-foods-that-decrease-stomach-acid) contains links to purchase AloeCure Advanced Formula Capsule and AloeCure Pure Aloe Vera Extract, as well as a general link to facilitate the purchase of AloeCure VeraFlex, AloeCure Advanced Formula Capsule, AloeCure Pure Aloe Vera Extract, and AloeCure Probiotic + Enzyme, and states: “For any who have suffered through a sleepless night due to excess stomach acid or indigestion, an acidic stomach can be a great cause of pain, distress, and discomfort . . . ALOE VERA . . . contains a natural stomach acid buffer called malic-calcium that neutralizes excess acid . . . It contains two active constituents - glycoproteins and polysaccharides. The former helps to reduce inflammation and hinder pain . . . Aloe Vera can soothe the esophagus track, too, and provide relief from irritation . . . Other studies indicate and suggest that Aloe Vera . . . contributes in helping to balance stomach acid.”
• The article titled “Aloe Vera vs. Apple Cider Vinegar” (https://blog.aloecure.com/blog/aloe-vera-vs-apple-cider-vinegar) contains links to purchase AloeCure Advanced Formula Capsule and AloeCure Pure Aloe Vera Extract, as well as a general link to facilitate the purchase of AloeCure VeraFlex, AloeCure Advanced Formula Capsule, AloeCure Pure Aloe Vera Extract, and AloeCure Probiotic + Enzyme, and states: “Aloe Vera supports digestive wellness due to its anti-inflammatory properties. For many people, digestive issues stem from the occurrence of inflammation within the digestive system, the gastrointestinal tract . . . Aloe Vera . . . can offer benefits for an inflamed GI tract.”
• The article titled “The Endless Benefits of Aloe Vera Gel” (https://blog.aloecure.com/blog/endless-benefits-aloe-vera) contains links to purchase AloeCure Advanced Formula Capsule and AloeCure Pure Aloe Vera Extract, and states: “Below we share some of our favorite ways aloe vera juice benefits us inside and out . . . When our bodies have too much inflammation, it can cause a range of problems from asthma and eczema to arthritis and rheumatism. Aloe’s main property is to be soothing as well as moistening which helps to clear inflammation throughout the body. The enzymes present in the plant’s inner gel produce an anti-inflammatory effect on the body . . .”
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 AloeCure Probiotic & Enzyme Blend and AloeCure VeraFlex 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, AloeCure Probiotic & Enzyme Blend and AloeCure VeraFlex 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 violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of any violations identified above 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.
You should take prompt action to correct any violations cited in this letter. Failure to adequately address this matter may lead to legal action, including, without limitation, seizure and injunction.
Within fifteen (15) 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 (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Jinkee M. Vila-Binayug, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have any questions regarding this letter, please contact Compliance Officer Vila-Binayug at
425-302-0413
.
Sincerely,
/S/
Miriam R. Burbach
District Director Program Division Director
Content current as of:
02/02/2021
Regulated Product(s)
Drugs
Food & Beverages