WARNING LETTER
Ambaya Gold Health Products, LLC
MARCS-CMS 648130 —
December 05, 2023
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Pilar G. Martin
Recipient Title
Owner
Ambaya Gold Health Products, LLC
10 Gideon Rd
Sedona
,
AZ
86336
United States
Issuing Office:
Division of Human and Animal Food Operations West IV
United States
Secondary Issuing Offices
United States
December 5, 2023
WARNING LETTER
Reference: CMS Case # 648130
Dear Ms. Martin:
This is to advise you that the U. S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.ambayagold.com in April and November 2023 and has determined that you take orders for the products Brain Balance, Immune System Boost, Dentist In A Bottle, Essensiac, Fulvic Green, Silver Solution, Detox Cleanse Renew, Magnesium Oil Spray, Silver Spray, and Pet Health+. We also reviewed your social media website at www.facebook.com/AmbayaGoldHealth, which directs consumers to your website at www.ambayagold.com to purchase your products. The claims on your websites establish these products are drugs under section 201(g)(1)(B)/(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 321(g)(1)(B)/(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 violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Unapproved New Drugs
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Brain Balance product
On the Brain Balance product webpage (https://ambayagold.com/products/brain-balance-regeneration):
• “Lithium orotate [an ingredient in Brain Balance] …great natural treatment for a wide range of mental health problems.”
On the “What is Ashwagandha?” blog post, dated June 20, 2022, (https://ambayagold.com/blogs/news/what_is_ashwagandha), which contains a hyperlink to purchase Brain Balance:
• Under the heading “Benefits of Top Rated Ashwagandha Supplements”:
− “1. Powerful anti-inflammatory…”
− “7. Reduce symptoms of depression”
− “8. Lower cholesterol and triglycerides”
On your Facebook account (https://www.facebook.com/AmbayaGoldHealth/) post, dated June 20, 2022:
• Under the heading “HEALTH BENEFITS OF ASHWAGANDHA” [an ingredient in Brain Balance]:
− “REDUCES BLOOD SUGAR LEVELS…helps in [sic] increased insulin secre-tion and improved insu-lin sensitivity.”
− “HELPS FIGHT CANCER…helps in reducing the growth of tumors, prevents cancer cells from growing”
− “IMPROVES THY-ROID FUNCTION…benefits people suffer-ing from hypothyroid-ism…”
− “REDUCES SYMP-TOMS OF DEPRES-SION… plays an essential role in reducing depression”
− “MAY LOWER CHO-LESTEROL AND TRI-GLYCERIDES…helps lower LDL, and VDL cholesterol and triglyceride levels and increase HDL levels.”
− “CAN PREVENT SEI-ZURES…used in traditional ayurvedic medi-cines as a cure for sei-zures and convulsions.”
− “[P]revents loss of bone mineral density and reduces bone reabsorp-tion.”
− “[H]elp prevent chronic eye diseases.”
Immune System Boost product
On the “Combating Allergies (The Holistic Way)” blog post, dated October 31, 2022, (https://ambayagold.com/blogs/news/combating-allergies-the-holistic-way), which contains a hyperlink to purchase Immune System Boost:
• “There are natural allergy remedies that have very little to no side effects and can be as effective (if not more) than allergy medications.”
• “If you find yourself constantly effected[sic] by allergies, check out our Immune System Boost.”
• “MSM [an ingredient in Immune System Boost] can decrease allergic reactions by lowering inflammation and inhibiting the release of cytokines and prostaglandins thanks to its anti-inflammatory and antioxidant effects. It binds to the mucosa, blocking host and allergen contact.”
• “Silver [an ingredient in Immune System Boost] …well documented natural antibacterial.”
On the “Keep your Immune System Naturally Strong During Flu Season” blog post, dated October 24, 2022, (https://ambayagold.com/blogs/news/keep-your-immune-system-naturally-strong-during-flu-season), which contains a hyperlink to purchase Immune System Boost:
• “Silver [an ingredient in Immune System Boost] …well documented natural antibacterial.”
On the “Naturally Strengthen Your Immune System” blog post, dated February 3, 2022, (https://ambayagold.com/blogs/news/naturally-strengthen-your-immune-system), which contains a hyperlink to purchase Immune System Boost:
• “Ambaya Gold’s Immune Boost [this phrase hyperlinks to the Immune System Boost product page] is…anti-microbial, anti-viral...”
On the “Top Science-Backed Benefits of MSM” blog post, dated October 10, 2022, (https://ambayagold.com/blogs/news/top-science-backed-benefits-of-msm), which contains a hyperlink to purchase Immune System Boost:
• “Have you heard about MSM [an ingredient in Immune System Boost] …it can help with a variety of conditions, like arthritis and joint pain.”
• Under the heading “Ten Reasons You Should Consider Taking MSM” [an ingredient in Immune System Boost]:
− “2. MSM May Have Anti-inflammatory Effects…may reduce the release of molecules linked to inflammation…inhibits NF-kB, a protein complex involved in inflammatory responses in the body…reduces production of cytokines such as TNF-a and IL-6, which are signaling proteins linked to systemic inflammation.”
− “3. MSM May Treat Arthritis and Joint Pain…Arthritis is probably the most known condition that MSM is used for, especially osteoarthritis. …MSM might lessen the pain associated with it. One study of 100 people…found that treatment with a supplement containing MSM for 12 weeks lessened pain, stiffness and swelling in the joints, compared to a placebo.”
− “4. MSM May Help with Digestive Problems…may improve symptoms in patients with Leaky Gut Syndrome…One study, however, did show oral intake of MSM assisted in protecting gut damage in rats with colitis. MSM supplements may also reduce swelling and discomfort caused by hemorrhoids.”
− “8. MSM May Relieve Allergies…MSM can decrease allergic reactions by lowering inflammation and inhibiting the release of cytokines and prostaglandins thanks to its anti-inflammatory. …It was found that allergy symptoms and lower respiratory symptoms were reduced in people with seasonal allergic rhinitis after taking MSM supplementation for one month.”
− “9. MSM May Help With Parasites…may be an effective treatment for worms, giardia and trichomonas. …MSM coats the gut lining making it impossible for parasites to attach themselves. They are then naturally flushed out of the body. Candida is when the body experiences an overgrowth in fungus which can cause various health problems. MSM changes the PH in your body where Candida can not [sic] thrive in.”
Essensiac product
On the Essensiac product webpage (https://ambayagold.com/products/essensiac):
• On the image of your product label:
− “[E]ssiac tea…for…reducing inflammation”
• “Slippery Elm Bark [an ingredient in Essensiac]… can provide anti-inflammatory support.”
On the “Honoring the Benefits of Slippery Elm Tree” blog post, dated November 7, 2022, (https://ambayagold.com/blogs/news/honoring-the-benefits-of-slippery-elm-tree), which contains a hyperlink to purchase Essensiac:
• “[H]ealth benefits of slippery elm bark [an ingredient in Essensiac] come from the biochemical compounds that are extracted from it. They include mucilage…[m]ucilage: Helps to soothe sore throats and suppress coughs…”
• “Tannins [a component of the slippery elm bark ingredient in the Essensiac product]: Contains…anti-inflammatory properties. Helps lower cholesterol, lower blood pressure…It also has antibacterial properties that help fight tooth decay.”
• “Sterols [a component of the slippery elm bark ingredient in the Essensiac product]: Plant sterols can help to lower cholesterol and prevent cardiovascular disease…”
• “[A]nti-inflammatory properties of fatty acids, tannins and plant sterols [components of the slippery elm bark ingredient in the Essensiac product] …may all contribute to Slippery Elm Bark’s use as an alternative anti-inflammation aid for some chronic conditions.”
• “…Slippery Elm (Ulmus fulva) [an ingredient in Essensiac] has been used…for help with a variety of health conditions, including: …Sore throat…Cough…Other chronic conditions that develop from inflammation”
On your Facebook account (https://www.facebook.com/AmbayaGoldHealth/) post, dated November 7, 2022:
• “[S]lippery Elm (Ulmus fulva) [an ingredient in Essensiac] has been used…to help with a variety of health conditions, including: …Sore throat…Cough…Other chronic conditions that develop from inflammation”
On your Facebook account (https://www.facebook.com/AmbayaGoldHealth/) post, dated February 4, 2022:
• “It assists the body to create an environment that fights against dis-ease…”
On your Facebook account (https://www.facebook.com/AmbayaGoldHealth/) post, dated May 14, 2021:
• “My morning routine includes…Essensiac for its…anti-inflammatory properties....”
Dentist In A Bottle product
On the Dentist In A Bottle product webpage (https://ambayagold.com/products/dentist-in-a-bottle):
• “Assistance with the prevention of tooth decay”
• “By reducing harmful bacteria growth and replacing essential minerals, Dentist in a Bottle…assists in the prevention and remediation of gum and tooth decay.”
• “I bought Dentist in a Bottle because my dentist told me I needed a root canal…used it twice a day, soaking the area for about two minutes. The pain and infection subsided after one day and disappeared after one week. A new dentist said that I did not need a root canal…”
• “…[A]lways had problems with my teeth and gums…led to lifelong chronic gum and tooth infections . . . has completely removed the plaque buildup and now my teeth and gums feel clean and healthy…my gums have stopped bleeding. …Dentist In A Bottle”
On the “Reasons You Should Switch to a Natural Mouthwash Today” blog post, dated September 5, 2022, (https://ambayagold.com/blogs/news/reasons-you-should-switch-to-a-natural-mouthwash-today), which contains a hyperlink to purchase Dentist In A Bottle:
• “Two main ingredients in our mouthwash, Dentist in a Bottle, are Fulvic and Silver. Both are known for their antibacterial properties and can be very effective at reducing harmful bacteria. Using these two together can help prevent gum disease and tooth decay.”
• “…Effective on Bacteria”
• “Assistance with the prevention of tooth decay”
• “Most natural rinses, like ours, contain popular ingredients like peppermint, rosemary, thyme, cinnamon bark, eucalyptus, wintergreen, lemon, clove and birch oil. Research has proven their anti bacterial [sic], antimicrobial and anti-inflammatory properties’”
• “‘Oral infections can result in inflammation in other parts of the body since our oral mucosa has a direct pathway to the bloodstream.’ …Our Dentist in a Bottle offers overall improvement in oral health...”
On your Facebook account (https://www.facebook.com/AmbayaGoldHealth/) post, dated September 5, 2022:
• “Fulvic and Silver [ingredients in Dentist In A Bottle] are known for their antibacterial properties and can be very effective at reducing harmful bacteria.”
On your Facebook account (https://www.facebook.com/AmbayaGoldHealth/) post, dated June 8, 2022:
• “By reducing harmful bacteria growth and replacing essential mineral, Dentist in a Bottle, freshens the mouth…while assisting in the prevention and remediation of gum and tooth decay.”
On your Facebook account (https://www.facebook.com/AmbayaGoldHealth/) post, dated July 12, 2021:
• “Our effective mouthwash is a natural alternative to toxic mouthwashes…reduces harmful bacteria growth and replaces essential minerals!”
Fulvic Green product
On the “The Surprising Benefits of Chlorophyll” blog post, dated August 1, 2022, (https://ambayagold.com/blogs/news/the-surprising-benefits-of-chlorophyll), which contains a hyperlink to purchase Fulvic Green:
• Under the heading “10 Amazing Benefits of Chlorophyll” [an ingredient in Fulvic Green]:
− “2. [R]epair small gut wounds.”
− “5. It’s also an excellent blood purifier that helps prevent or even reverse dis-ease [sic] in your body.”
On the “Superfood Hawaiian Spirulina” blog post, dated June 27, 2022, (https://ambayagold.com/blogs/news/superfood_hawaiian_spirulina), which contains a hyperlink to purchase Fulvic Green:
• Under the heading “Benefits of Spirulina” [an ingredient in Fulvic Green]:
− “[R]educes allergy symptoms”
− “[G]reat anti-inflammation”
− “[C]an reduce risk of cancer”
− “[P]revents & helps with cardiovascular disease”
• Under the heading “Why Take Hawaiian Spirulina [an ingredient in Fulvic Green] Supplements?”:
− “Lowers Blood Pressure…A great way to lower your blood pressure is to add spirulina to your diet.”
− “[S]pirulina …Foods high in antioxidants have been proven to lower inflammation and eliminate free radicals which can prevent degenerative brain diseases…spirulina helps with ADHD.”
− “Lower Blood Sugar…Spirulina can lower blood sugar levels.”
− “Can Reduce Risk of Cancer…Adding spirulina to your diet can reduce risk of cancer. Testing…showed the spirulina increased the production of antibodies as well as infection-fighting proteins and cells that help to protect against cancer…spirulina could have potential to prevent a number of other diseases”
− “Protect Against Liver Disease…Protection against liver disease”
− “Detox from Heavy Metals…Spirulina acts as a detox for your body, especially from heavy metals, like arsenic. …United States is one of the countries that are most affected by arsenic poisoning. Spirulina is a natural remedy for getting rid of that arsenic and other metals that have accumulated in the body.”
− “Reduce Cholesterol…Spirulina can greatly reduce cholesterol as well. Cholesterol can be a problem that leads to heart disease…Anyone at risk for heart disease…should consider adding spirulina to their diet.”
On your Facebook account (https://www.facebook.com/AmbayaGoldHealth/) post, dated August 1, 2022:
• Under the heading “CHLOROPHYLL [an ingredient in Fulvic Green] BENEFITS”:
− “ANTI-CARCINOGENIC”
On your Facebook account (https://www.facebook.com/AmbayaGoldHealth/) post, dated June 27, 2022:
• Under the heading “Benefits of Spirulina” [an ingredient in Fulvic Green]:
− “[R]educes allergy symptoms”
− “[G]reat anti-inflammation”
− “[C]an reduce risk of cancer”
Silver Solution product
On the Silver Solution product webpage (https://ambayagold.com/products/ag-liquid-silver-solutions):
• On the image of your product label:
− [W]ide-spectrum antibacterial solution minimizes risk of infections”
• “Silver [an ingredient in Silver Solution] is considered a very powerful antibacterial element because its ions cause inhibition of bacterial growth. Silver ions' interaction with enzymes and proteins play an important and essential role in antibacterial efficacy in the body.”
On the “The Many Uses of Silver” blog post, dated December 27, 2021, (https://ambayagold.com/blogs/news/the-many-uses-of-silver), which refers to your Silver Solution product available for purchase on your website (www.ambayagold.com):
• “Taking Silver [an ingredient in Silver Solution] orally can assist with symptoms of colds, sinus infections…can lessen the symptoms of allergies and arthritis.”
• “Silver [an ingredient in Silver Solution] can fight hundreds of disease causing [sic] bacteria & viruses...”
• “If you don't like taking antibiotics for urinary tract or bladder infections, silver [an ingredient in Silver Solution], a natural alternative can assist to clear up your system by taking 1/2 teaspoon of our Silver orally…”
On the “What's the Difference Between Silver and Gold?” blog post, dated December 13, 2021, (https://ambayagold.com/blogs/news/whats-the-difference-between-silver-and-gold), which refers to your Silver Solution product available for purchase on your website (www.ambayagold.com):
• “Silver [an ingredient in Silver Solution] ions cause inhibition of bacterial growth. Therefore they are naturally antibacterial. Silver ions, and their interaction with enzymes and proteins play an important role in antibacterial efficacy in the body.”
• “…Silver [an ingredient in Silver Solution] can be used as a non-toxic, safe, and easy to use supplement as a natural antibiotic…”
On your Facebook account (https://www.facebook.com/AmbayaGoldHealth/) post, dated December 19, 2021:
• “Silver [an ingredient in Silver Solution] is naturally antibacterial…”
Detox Cleanse Renew
On the Essentials Kit webpage (https://ambayagold.com/pages/the-essentials-kit), which contains a hyperlink to purchase Detox Cleanse Renew:
• “RESTORE FULVIC [an ingredient in Detox Cleanse Renew] RESTORE HEALTH…Toxic build up and mineral deficiencies are two of the biggest health issues that people face today and can lead to symptoms like: …Blood Sugar Imbalances…Insomnia…”
• “BENEFITS OF FULVIC… REDUCES INFLAMMATION …FIGHTS PATHOGENS...”
On the “The Best Detox For Environmental Toxins And Radiation” blog post, dated July 4, 2022, (https://ambayagold.com/blogs/news/the_best_detox_for_environmental_toxins_and_radiation), which contains a hyperlink to purchase Detox Cleanse Renew:
• “[C]ancers, disease and birth defects are increasing in both humans and animals due to environmental pollutants full of heavy metals and other toxins. …The best way to remove toxic heavy metals from environmental pollution and radiation from the body is by chelating them out with a product…Clinoptilolite Zeolite [an ingredient in Detox Cleanse Renew] is by far the best way to combat these toxins.”
• “The miracle toxin magnet, Zeolite [an ingredient in Detox Cleanse Renew] …draws heavy metals and toxins to the Zeolite…enabling the toxins to be safely eliminated…”
• “As the heavy metals and toxins are eliminated the immune system can grow strong again to better fight off viruses, bacteria and deformed cells...”
• “Routinely detoxifying with zeolite [an ingredient in Detox Cleanse Renew] is necessary because when you’re exposed to toxins, your body stores them in your cells. Over time, toxins and radiation can build up to dangerous levels—leading to disease, chronic fatigue, brain fog and even cancer.”
Silver Spray product
On the Silver Spray product webpage (https://ambayagold.com/products/ag-liquid-silver-spray):
“AMBAYA GOLD . . . SILVER SPRAY . . . wide-spectrum antibacterial solution minimizes risk of infections” [from your product label for SILVER SPRAY]
“Silver Spray . . . Natural antibacterial . . . Disinfects like hydrogen peroxide without the burn . . .” [https://www.instagram.com/p/CmSADzUva93/ and https://www.facebook.com/AmbayaGoldHealth/posts/pfbid02Hkd21pHbyrU5TL1MaAgRh1E9CJWtbKVenM5kyQaRtKtC4G9XL2ZMZZ58u7LApMGQl]
Magnesium Oil Spray product
“Our fast acting topical Magnesium Oil Spray offers the benefits of pure Magnesium Oil in a proprietary Fulvic base. . . .This convenient spray is designed is designed to provide relief from body tension and soreness quickly and effectively. . . .For muscle cramps or pains, spray directly on problem area.” [from your product website, https://ambayagold.com/products/magnesium-oil-spray]
Specifically, these products are intended for use as a first aid antiseptic, and an external analgesic, respectively
1
Unapproved New Drugs
Your Brain Balance, Immune System Boost, Dentist In A Bottle, Essensiac, Fulvic Green, Silver Solution, and Detox Cleanse Renew 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)]. 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.
Further, your “Silver Spray” product, containing silver, is a first aid antiseptic subject to section 505G of the FD&C Act, which governs nonprescription drugs marketed without an approved application. Specifically, your silver-containing product falls under section 505G(a)(5) of the FD&C Act, because FDA has determined that no silver containing OTC drugs are generally recognized as safe and effective under a final determination issued under 21 CFR part 330.
2, 3
Therefore, Silver Spray is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No FDA-approved application pursuant to section 505 of the FD&C Act is in effect for this drug product. Accordingly, “Silver Spray” is an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section and 301(d) of the FD&C Act, 21 U.S.C. 331(d).
Your “Magnesium Oil Spray” is a topical external analgesic drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Under section 505G of the of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. With respect to OTC external analgesic drug products, such products are deemed to be GRASE and not new drugs if, among other things, they conform to the conditions of use set forth in the final administrative order, Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use (“M017”).
4
However, “Magnesium Oil Spray” does not conform to the conditions specified in the final administrative order for the reasons described below. Your “Magnesium Oil Spray” is not formulated and labeled as an external analgesic counterirritant drug product that is consistent with the final administrative order. Specifically, your product is labeled to contain the ingredients magnesium chloride, fulvic, indium, aloe vera, pyridoxine HCl (B6), MSM, and plant based phytonutrients, all of which are outside of the final applicable administrative order. According to 21 CFR 201.66(b)(2), an “active ingredient” means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans. Although your firm does not specifically list these ingredients as active ingredients, your product website includes statements that claim this combination of ingredients is “designed to provide relief from body tension and soreness” as a treatment for symptoms related to magnesium deficiency that include “leg cramps and muscle soreness,” along with “migraines, insomnia, [and] fatigue.” Such statements demonstrate that those ingredients are considered “active ingredients” as defined by 21 CFR 201.66(b)(2) because this combination of ingredients is intended to furnish pharmacological activity. However, this combination of active ingredients is not permitted under the applicable final order nor are any of these ingredients permitted as a single active ingredient in an external analgesic product under the final administrative order.
Thus, as formulated and labeled, “Magnesium Oil Spray” does not comply with the final administrative order described above or any applicable proposed or final rule. FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “Magnesium Oil Spray” is GRASE for use under the conditions prescribed, recommended or suggested in its labeling. Moreover, there is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Therefore, “Magnesium Oil Spray” is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Accordingly, “Magnesium Oil Spray” is an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section and 301(d) of the FD&C Act, 21 U.S.C. 331(d).
In addition, “Silver Spray” and “Magnesium Oil Spray” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because they are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, are not the subject of applications approved under section 505 of the FD&C Act, 21 U.S.C. 355, and do not comply with the requirements under section 505G of the FD&C Act, 21 U.S.C. 355h. Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Misbranded Drugs
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 Brain Balance, Silver Solution, Dentist In A Bottle, Essensiac, Fulvic Green, and Detox Cleanse Renew 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, the Brain Balance, Silver Solution, Dentist In A Bottle, Essensiac, Fulvic Green, and Detox Cleanse Renew 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)].
Unapproved New Animal Drugs
Based on our review of your website www.ambayagold.com and your social media website www.facebook.com/AmbayaGoldHealth, your Pet Health+ product is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal.
Examples of claims observed on your website and social media website that provide evidence that your product is intended for use as a drug include:
Pet Health+ product
On the Pet Health+ product webpage (https://ambayagold.com/products/pet-health):
• “Detox of heavy metals, chemicals and other toxins* Protection from worms, parasites, and fungus* Natural anti-inflammatory agents*…Protection from infection*…Accelerated wound recovery*”
• “In our Pet Health +, our clean sourced Clinoptilolite Zeolite is formulated and suspended in a freshwater Humic and Fulvic liquid solution. The Humic helps to penetrate deep into the cells, providing a cleansing action by safely binding harmful toxins.”
• “Why Silver and Gold? Monatomic Silver is considered a powerful natural antibacterial element because its ions cause inhibition of bacterial growth. Silver ions' interaction with enzymes and proteins play an important and essential role in antibacterial efficacy in the body.”
• A customer testimonial from 2/18/2022 states, “This product has help [sic] to support for our new dog’s… anxiety issues…”
On the “Natural Remedies for Pain Relief in Dogs” blog post, dated December 5, 2022, (https://ambayagold.com/blogs/news/natural-remedies-for-pain-relief-in-dogs), which contains a hyperlink to purchase Pet Health+:
• “Holistic pet supplements and pain relievers can have a wide range of benefits like: …Assistance with detox of heavy metals, chemicals, and other toxins…Protection from worms, parasites, fungus, and infection…Natural anti-inflammatory agents…Accelerated wound recovery…All of the above benefits have been reported by users of our pet multivitamin, Pet Health+ [hyperlinks to the Pet Health+ product page].
On your Facebook account (https://www.facebook.com/AmbayaGoldHealth/) post, dated May 15, 2022:
• “Pet Health+ helps…Assist with detox of heavy metals, chemicals, and other toxins…Protect from worms, parasites, fungus, and infection”
On your Facebook account (https://www.facebook.com/AmbayaGoldHealth/) post, dated October 8, 2021, with three photos of a cat:
• “…[H]er cat’s obsessive grooming…This caused her to form “hot spots” where the skin had become inflamed and formed open wounds. …When modern medicine didn’t help, she tried Pet Health+ and here are her results after ONLY a week and a half!”
Your Pet Health+ product is a "new animal drug" under section 201(v) of the Act [21 U.S.C. § 321(v)] because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Pet Health+ is not approved, conditionally approved, or index listed by the FDA, and therefore this product is considered unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of an adulterated drug is prohibited under section 301(a) of the Act [21 U.S.C. § 331(a)].
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Carrie Jolly, Compliance Officer, via email at carrie.jolly@fda.hhs.gov or at 6th Ave and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado. You may reach Ms. Jolly at carrie.jolly@fda.hhs.gov or (303) 236-9656.
Sincerely,
/S/
E. Mark Harris
Program Division Director
Office of Human and Animal Food Operations –
West Division 4
_____________________
1
It is not clear whether you intend your “Silver Spray” and “Magnesium Oil Spray” products to be marketed as dietary supplements. Your firm lists these two products on your website under the heading “Supplements.” Under section 201(ff)(2)(A)(i) of the FD&C Act [21 U.S.C. § 321(ff)(2)(A)(i)], a dietary supplement is defined, among other things, as a product intended for ingestion. Topical products and other products that are not intended for ingestion cannot be dietary supplements.
2
See 21 CFR 310.548(b): "Any OTC drug product containing colloidal silver ingredients or silver salts that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) for which an approved application or abbreviated application under section 505 of the Act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application or abbreviated new drug application, such product is also misbranded under section 502 of the Act.”
3
FDA’s final determination was codified in regulations at 21 CFR 310.545(a)(8)(i). Under section 505G(k)(2)(A) of the FD&C Act, the non-monograph conditions in 21 CFR 310.545 in effect on the day before the date of enactment of the CARES Act (i.e., March 26, 2020) are deemed to be a final administrative order. The final administrative order is entitled “Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered Over-the-Counter for Certain Uses” (See Order ID OTC000007, available at OTC Monographs@FDA, https://dps.fda.gov/omuf).
4
Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs," notably, conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 CFR. part 330 prior to enactment of the CARES Act. In the case of OTC anorectal drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use (See Order ID OTC000033, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf).
Content current as of:
04/02/2024
Regulated Product(s)
Food & Beverages