WARNING LETTER
Dr. Sam Robbins, Inc. dba HFL Solutions, LLC
MARCS-CMS 608729 —
August 28, 2020
Delivery Method:
United Parcel Service
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Sam Robbins Ahdoot
Dr. Sam Robbins, Inc. dba HFL Solutions, LLC
13077 Bluff Creek Dr.
Playa Vista
,
CA
90094
United States
sam@drsamrobbins.com
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
August 28, 2020
WL 608729
Dear Dr. Robbins:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses https://my4hfl.com and https://drsamrobbins.com in June 2020 and has determined that you take orders there for your products AlphaViril, Blood Flow Optimizer, Blood Pressure Optimizer, Blood Sugar Optimizer, CHEATmeals, CholesLo, Inflame & Pain Relief, LeanOptimizer, Perfect Vitamin D & K, and ProVanax, as well as your websites https://www.inflamepainrelief.com, https://alphaviril.com, and https://healthfitnesslongevity.com where you take orders for these products.
We also reviewed your social media websites at https://www.facebook.com/DrSamRobbins/, https://twitter.com/drsamrobbins, https://www.instagram.com/drsamrobbsin/, www.youtube.com/user/drsamrobbins/, and www.youtube.com/channel/UCwu7T1j1JvRcpYAFg5SEixQ/, which contain links to your websites at https://drsamrobbsin.com, https://my.4hfl.com, and/or https://healthfitnesslongevity.com. Additionally, we reviewed product listings on your Amazon storefront at https://www.amazon.com/s?i=merchant-items&me=A3S4W2SM9FX1BR, which you operate under the name, HFL - Dr Sam Robbins Official Store.
Although you label and promote CholesLo as a dietary supplement, laboratory analyses of two samples collected by the FDA determined that this product contains lovastatin. Lovastatin is the active ingredient in Mevacor® and its generic counterparts, which are FDA-approved drugs used to treat patients with primary hypercholesterolemia. The first sample contained approximately 14.3 mg per capsule. If taken at the maximum dose recommended on the label, your product would provide 85.8 mg lovastatin per day, which is above the maximum recommended daily dose of lovastatin in Mevacor and its generic counterparts. The second sample contained approximately 0.4141 mg per capsule. If taken at the maximum dose recommended on the label, your product would provide 2.48 mg lovastatin per day, which is less than half the recommended daily dose of lovastatin in Mevacor and its generic counterparts.
FDA has issued a warning to consumers not to use “CholesLo” (see the “CholesLo” Immediate Public Notification) as a result of the lab analyses finding lovastatin in your products.
Traditional red yeast rice does not contain more than trace amounts of lovastatin, if any. Because your CholesLo product contains red yeast rice with enhanced or added lovastatin, it cannot be marketed as a dietary supplement. Section 201(ff)(3)(B)(i) of the Act [21 U.S.C. § 321(ff)(3)(B)(i)] specifically excludes from the dietary supplement definition articles that are approved as new drugs under section 505, unless the article was marketed as a dietary supplement or food before its approval as a new drug. FDA approved Mevacor® as a new drug on August 31, 1987; neither lovastatin as a single ingredient, nor any red yeast rice product manufactured and promoted for lovastatin content, was marketed as a dietary supplement or as a food before that date. FDA’s conclusions that lovastatin’s approval as a new drug preceded its marketing as a food or dietary supplement and that a lovastatin-enhanced red yeast rice product is not a dietary supplement were upheld in litigation involving a product called Cholestin.
Pharmanex, Inc. v. Shalala
, 221 F.3d 1151 (10th Cir. 2000); 2001 U.S. Dist. LEXIS 4598 (D. Utah Mar. 30, 2001) (district court opinion on remand).
In addition to analyzing your products, we have reviewed your websites, including your social media websites, and Amazon storefront webpage as noted in the beginning of this letter, and have determined that claims on your labels and websites establish that these products are drugs under section 201(g)(1)(B) and 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 321(g)(1)(B) and 321(g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the human 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.
CholesLo
Examples of some of the website and product label claims that provide evidence that your CholesLo product is intended for use as a drug include:
On your product label of CholesLo:
• “Promotes Healthy Cholesterol Levels”
• “Supports Balanced HDL/LDL Ratios”
• “WHY CholesLo™ Is Better? . . . One of the primary causes of high cholesterol, is the change in your hormones due to aging. CholesLo™ is our best solution on the market”
On your website https://my.4hfl.com/choleslo:
• In your video embedded on the webpage,
o “NATURALLY improve your cholesterol levels from
within
. . . The ingredients in CholesLo™ are clinically proven… to help… 1. Create healthy cholesterol levels. 2. Optimize your HDL/LDL ratios…. 4. [R]epair your LIVER… 6. Naturally lower blood sugar levels and total-body ‘inflammation’.”
o “CholesLo™ . . . it’s a COMPLETE solution that focuses on ALL the potential… …causes of heart disease”
o “In fact, if CholesLo™ doesn’t help lower your total cholesterol by
30 pts in only 30 days
. . . I’ll give you a full refund . . . I can make such a guarantee . . . because I’ve seen CholesLo™ work for over 12 years”
• “Most likely you’re reading this because you’re interested in improving your cholesterol and lipid levels naturally . . . CholesLo’s 20+ year proven formula can help you achieve healthy cholesterol and balanced lipid levels.”
• “CholesLo™ also helps reduce inflammation – a major leading factor of many health problems, which can cause a heart attack or stroke.”
• “The reason I formulated CholesLo™ in 1998 for my parents, was because they were having too many negative side-effects from their prescription, cholesterol lowering ‘statin’ drugs.”
On your website https://www.choleslo.drsamrobbins.com/sub/research.php:
• You provide a chart titled, “CholesLo’s Average 30-Day Improvements,” and several graphs including, “Average Cholesterol Improved In 8 Weeks = 46 pts (19%),” “Randomized Double-Blind Study Average Percentage (%) Of Lipids Improved in 20 Weeks,” and “Average LDL Improved in 21 Days = 8.9%,” which indicate that your product is intended for use in lowering cholesterol levels.
On your website https://www.choleslo.drsamrobbins.com/sub/ingredients.php:
• “‘The combination of red yeast rice extract and policosanols [ingredients in your product CholesLo] is both safe and effective in the treatment of hypercholesterolomic children . . . significantly reduce cholesterolemia and achieved acceptable plasma LDL-C levels in elderly hypercholesterolemic patients.’”
• “If you have high LDL cholesterol levels, garlic [an ingredient in your product CholesLo] supplementation is especially important because LDL cholesterol oxidation causes atherosclerosis . . . Most importantly, garlic prevents abnormal platelet aggregation (thrombosis) via several different mechanisms. The formation of arterial blood clots is the primary cause of most heart attacks and strokes.”
• “The discovery that artichoke leaf extract [an ingredient in your product CholesLo] reduces elevated cholesterol levels opens up exciting perspectives in the prevention and treatment of arteriosclerosis and coronary heart disease.”
• “Because of their ability to block dietary cholesterol absorption, phytosterols [an ingredient in your product CholesLo] can help lower your cholesterol levels. In the last few years, clinical research has also discovered other effects, including reducing symptoms of an enlarged prostate, improving the control of blood sugar among people with diabetes, and reducing inflammation among patients with autoimmune diseases such as rheumatoid arthritis and lupus.”
We also reviewed your websites and determined that you take orders there for AlphaViril, Blood Flow Optimizer, Blood Pressure Optimizer, Blood Sugar Optimizer, CHEATmeals, Inflame & Pain Relief, LeanOptimizer, Perfect Vitamin D & K, and ProVanax, which your websites promote for conditions that cause the products to be drugs under sections 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The claims on your websites establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Inflame & Pain Relief
On your websites https://my.4hfl.com/inflame-pain-relief/ and https://inflamepainrelief.com:
• “It’s doctor formulated to naturally help lower the 14 Primary inflammatory & pain triggers in the body”
• “In fact, inflammation is linked to . . . arthritis[,] . . . heart disease (heart attacks & strokes)[,] obesity[,] . . . cancer and auto-immune diseases[,] . . . brain aging (dementia, Alzheimer’s, Parkinson’s, etc.)[,] . . . diabetes & high blood sugar[,] allergies & asthma”
On your website https://www.inflamepainrelief.com/sub/ingredients.php:
• “[D]elays or even reverses many brain diseases and age-related decreases in brain function, including Alzheimer’s disease.”
• “Lowers Heart Disease . . . Several studies suggest that Curcumin [an ingredient in your product Inflame & Pain Relief] leads to improvements in endothelial function in the heart and can lower the risk of a heart attack by 65%.”
• “Avoid & Treat Cancer: [Curcumin] has been studied as a beneficial herb in cancer treatment, by causing death to cancerous cells and reducing tumor growth.”
• “Cat’s claw’s [an ingredient in Inflame & Pain Relief] anti-inflammatory effects have been commonly used to treat both rheumatoid arthritis and osteoarthritis.”
Perfect Vitamin D & K
On your website https://my.4hfl.com/perfect-vitamin-dk/:
• “Clinically proven to reduce the calcification of arteries”
• “Symptoms of Low Vitamin D3…Cancer…Heart Disease…Diabetes…Mental Disorders…Cold & Flu…Kidney Disease…”
On your website https://vitamin-dk.drsamrobbins.com/sub/ingredients.php:
• “Boosts Immune System: Dramatically reduces getting sick, the cold and flu.”
• “Fights Diseases: Heart disease, strokes, multiple sclerosis, diabetes, Alzheimer's and other dementias.”
• “Reduces Cancer: Skin, colon, ovarian, pancreatic, prostate, lung, lymphoma”
• “Healthy Blood Clotting: Important for avoiding a heart attack or stroke.”
On your webpage titled “Everyone Should Take This Steroid & Reduce Cancer By 50%,” on your website https://drsamrobbins.com/everyone-should-take-this-steroid-reduce-cancer-by-50/, in which you state “the name of this steroid is called Calcitriol. Also known as Vitamin D [an ingredient in your product Perfect Vitamin D & K].”
• In a video embedded on this webpage, which is also posted to your YouTube channel at the website www.youtube.com/watch?v=DRyiWHDd66Q with the hashtag, #cancer,
o “This steroid is extremely powerful at improving your health, while also reducing diseases and different forms of cancer, by as much as 50%”
o “Reduces inflammation”
o “Improves blood sugar levels”
o “So do yourself a favor and make sure you get some extra Vitamin D . . . helping to reduce illnesses, diseases, and cancer.”
• “Benefits Of This Steroid: . . . reduce hip fractures by 75%[,] Dramatically improves your immune system by reducing colds and flus[,] Reduces depression . . . Improves brain function, memory and reduces Alzheimer’s disease”
• “Reducing Cancer[:] Breast cancer by 50%[,] Liver cancer by 33%[,] Prostate cancer by 50%[,] Colon cancer by 25-35%[,] Skin cancer by 20-40%”
ProVanax
On your website https://www.provanax.drsamrobbins.com/sub/research.php:
• You provide several graphs including, “HAM-A: Severity of Anxiety Before & After ProVanax™,” “HAM-D: Severity of Depression Before & After ProVanax™,” “Improvement In Panic Attacks & Stress Reduction,” which indicate that your product is intended for use in reducing depression and anxiety.
On your website https://provanax.drsamrobbins.com/sub/ingredients.php:
• “Study 1 – Anxiety & Sleep: One study of people with mild-to-moderate anxiety disorders and sleep disturbances, showed 85% of subjects that supplemented with lemon balm extract [an ingredient in your product ProVanax] achieved full remission for insomnia and 70% of the subjects had complete relief of anxiety symptoms.”
• “St. John's Wort [an ingredient in your product ProVanax] was 2.7 times superior to a placebo in relieving depressive symptoms and was as effective as standard antidepressant drugs.”
• “[F]ound that St. John's Wort extract to be as effective in elderly German patients as Prozac”
• “[I]nositol [an ingredient in your product ProVanax] . . . supplementation has shown to exert some very beneficial effects in cases of depression, panic attacks and even diabetes.”
On your webpage titled “7 Best Natural Alternatives To Benzo Drugs & Fixing Anxiety,” on your website https://drsamrobbins.com/mood-happiness/7-best-natural-alternatives-to-benzo-drugs-fixing-anxiety/, where you also provide a link to the product page for Provanax on your website, https://www.provonax.drsamrobbins.com:
• “[Y]ou should take the following herbs: St John’s Wort extract[,] Passion Flower extract[,] Valerian extract [ingredients in your product ProVanax]. . . These work similar to benzo drugs, but without any of the negatives.”
• “In fact, this is the same exact formula . . . I’ve used instead of the harmful Xanax.”
Blood Sugar Optimizer
On your website https://healthfitnesslongevity.com/products/blood-sugar-optimizer:
• “Berberine [an ingredient in your product Blood Sugar Optimizer] . . . can have powerful benefits for those with diabetes. . . . Clinical Trials published in Metabolism revealed a decrease in hemoglobin A1C levels and regulated blood sugar in individuals who had recently been diagnosed with Type 2 Diabetes.”
• “Bitter Melon [an ingredient in your product Blood Sugar Optimizer] . . . help lower blood glucose levels. In addition to controlling blood sugar, its [sic] suggested that this super food can even help lower high cholesterol.”
On your webpage titled “7 Clinically Proven Foods Which Lower Blood Sugar & Help Avoid & Reverse Diabetes,” in which you link to your Blood Sugar Optimizer product page:
• “Bitter Melon, Gymnema Sylvestre, Fenugreek, Banaba Leaf and Cinnamon Extract [ingredients in your product Blood Sugar Optimizer] . . . create healthy blood sugar levels and lower A1C levels.”
Blood Pressure Optimizer
On your website https://healthfitnesslongevity.com/products/blood-pressure-optimizer:
• “Grape Seed Extract [an ingredient in your product Blood Pressure Optimizer] . . . can help to lower blood pressure and improve cholesterol.”
• “Celery Seeds [an ingredient in your product Blood Pressure Optimizer] contain a key blood pressure-lowering compound”
• “Lycopene [an ingredient in your product Blood Pressure Optimizer] . . . has been studied to have significant impacts on reducing blood pressure.”
• “Now you can control hypertension naturally”
• “Aging increases blood pressure and your risk for heart attacks and strokes . . . Now you can reduce your blood pressure, risk factors and worry with one solution – naturally.”
Lean Optimizer
On your website https://healthfitnesslongevity.com/products/lean-optimizer:
• “African Mango [an ingredient in your product Lean Optimizer] can help . . . prevent obesity by activating enzymes that control glucose and breakdown fat.”
• “Green Tea Extract [an ingredient in your product Lean Optimizer] . . . its [sic] also been linked to managing blood pressure”
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of CholesLo and Provanax for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
On your website https://reviews.4hfl.com/select.php:
• “It was a full year between blood tests and the entire time I was taking CholesLo five days each week, six pills per day. My cholesterol number has dropped 101 points. My HDL and LDL numbers are vastly improved as well.”
• “In August I went for a check up and yes, that's right, my cholesterol was high at 298 . . . I ordered in two bottles [of CholesLo], one for myself, and one for my husband. We followed the bottle directions each week. Three weeks later . . . The number was 226. My bad cholesterol had come down to 126. Unbelievable! That is a drop of 72 points in the LDL (bad) cholesterol. We would recommend this product to everyone for high cholesterol.”
• “My son-in-law takes it [Provanax] also, for ADHD.”
When scientific references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. Your websites provide the following publications reporting the results of studies pertaining to the use of CholesLo and its ingredients for the prevention and treatment of hypercholesterolemia and cardiovascular diseases:
On your websites https://my.4hfl.com/choleslo and https://choleslo.drsamrobbins.com/sub/research.php:
• “Cholesterol-Lowering Abilities of a Novel Proprietary Preparation CholesLo™ -A Randomized, Double Blind, Placebo-Controlled Study.”
On your website https://www.inflamepainrelief.com/sub/ingredients.php:
• “Sime S, Reeve VE. Protection from inflammation, immunosuppression and carcinogenesis induced by UV radiation in mice by topical Pycnogenol® [an ingredient in your product Inflame & Pain Relief]. Photochem Photobiol. 2004 Feb;79(2):193-8.”
On your website https://my.4hfl.com/provanax:
• Beneath the heading “Provanax™ Clinical Study”: “Investigations Into The Anti-Anxiety, Anti-Depressant Claims Of A Herbal Preparation: A Clinical Trial”
• Under references on the details tab of the Provanax product page: “Cases J, Ibarra A, Feuillere N, et al. Pilot trial of Melissa officinalis L. leaf extract [an ingredient in your product Provanax] in the treatment of volunteers suffering from mild-to-moderate anxiety disorders and sleep disturbances. Med J Nutrition Metab. 2011 Dec;4(3):211-8.”
Some examples of the claims on your social media websites that provide evidence that these products are intended for use as drugs include the following:
On your Facebook social media website, https://www.facebook.com/DrSamRobbins/,
• On a March 20, 2020 photo post: “To-Do List for Lower Blood Pressure . . . take Blood Pressure Optimizer” accompanied with a caption that links to a webpage on your website for your Blood Pressure Optimizer product
• On a May 8, 2020 post: “5 easy ways to decrease your heart failure symptoms . . . and avoid a heart attack or stroke,” and provide a link to a webpage on your website for your Blood Flow Optimizer product
On your Instagram social media website, https://www.instagram.com/drsamrobbins/,
• On a March 12, 2019 post that is captioned: “Today I’m going to talk about lowering your blood pressure naturally in less than 30 days, using a specific and clinically proven form of Grape Seed Extract [an ingredient in your product Blood Pressure Optimizer]. I’ll also reveal the exact formula my dad used to lower his blood pressure by 23% in just a few days . . . https://www.drsamrobbins.com/blood-pressure/a-clinically-proven-way-to-lower-your-blood-pressure-in-only-30-days-using-grape-seed-extract/ . . . #lowerbloodpressure”
On your Twitter social media website, https://www.twitter.com/drsamrobbins,
• On a March 28, 2020 post: “Ginger [an ingredient in your Blood Flow Optimizer product] is an amazing inflammatory and a great substitute to aspirin! Here are other benefits of ginger + other spices CLINICALLY PROVEN to improve blood flow: drsam.co/s/TW/SpicesCle…”
• On a May 9, 2020 post: “Did you know that poor blood flow is a primary cause of a heart attack or stroke? I have a family history of heart attacks and strokes so I formulated a natural remedy that can improve your blood flow in only 30-days. drsam.co/s/TW/ImproveBl…”
On an October 28, 2019 YouTube video titled, “WARNING: Prostate cancer is linked to LOW testosterone! New Research – by Dr Sam Robbins,” posted with your YouTube account, Men’s Health by Dr. Sam Robbins, on the website https://www.youtube.com/watch?v=0Iukbm-DT_Q:
• In the video: “LOW testosterone is the REAL health risk in prostate cancer . . . So today you’ll discover the REAL cause AND cure for prostate cancer . . . Now, for decades scientists have give men with prostate cancer, anti-androgen drugs such as Flutamide . . . In fact, increasing your testosterone levels . . . Is the REAL CURE for prostate cancer!”
• In the video description:
o “Here's my favorite, scientifically proven formula for increasing your testosterone ONLY with natural ingredients” and you provide a link to your AlphaViril website, https://alphaviril.com, where you take orders for your product AlphaViril.
o “In fact, one study included 18 total studies involving almost 20,000 men and it showed that increasing testosterone helped protect against prostate cancer.”
Furthermore, you operate an Amazon storefront under the name, HFL - Dr Sam Robbins Official Store. We reviewed your product listings for Blood Flow Optimizer, CHEATmeals, and LeanOptimizer. The product descriptions on these listings provide evidence that these products are intended for use as drugs include the following:
On the Blood Flow Optimizer webpage, https://www.amazon.com/stores/page/EF3755F8-FFDE-4688-B985-BCC411AB8C1A:
• “Nattokinase [an ingredient in your Blood Flow Optimizer product] is by nature a blood thinner”
• “Ginger [an ingredient in your Blood Flow Optimizer product] boasts anti-inflammatory properties that position it as an effective substitute for aspirin. Well documented for helping to prevent blood clots, its [sic] also been known to fight against atherosclerosis which can ultimately help to reduce the risk of heart attack or stroke.”
• “Green Tea Extract [an ingredient in your Blood Flow Optimizer product] . . . linked to managing blood pressure”
• “White Willow Extract [an ingredient in your Blood Flow Optimizer product] contains salicin, a natural blood thinner and anti-inflammatory.”
• “Aging causes poor blood flow to the brain, which means less oxygen resulting in memory & cognitive problems, even Alzheimer’s and Parkinson’s. The good news is that you can now reverse this ‘aging problem’, naturally.”
On the Blood Flow Optimizer product listing:
• “Decrease the plaque buildup”
• “Strengthen the walls of the arteries and blood vessels, reducing the chance of a rupture or tear.”
• “Inhibit future buildup of plaque and calcium, which can help prevent a heart attack or stroke.”
On the CHEATmeals product listing:
• “Lower Bad Cholesterol, LDL and Triglycerides”
• “Normalize Blood Sugar and Glucose Levels”
On the LeanOptimizer product listing:
• “Helps lower cholesterol and blood sugar levels”
Your AlphaViril, Blood Flow Optimizer, Blood Pressure Optimizer, Blood Sugar Optimizer, CHEATmeals, CholesLo, Inflame & Pain Relief, LeanOptimizer, Perfect Vitamin D & K, and ProVanax products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. 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 AlphaViril, Blood Flow Optimizer, Blood Pressure Optimizer, Blood Sugar Optimizer, CHEATmeals, CholesLo, Inflame & Pain Relief, LeanOptimizer, Perfect Vitamin D & K, and ProVanax 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, AlphaViril, Blood Flow Optimizer, Blood Pressure Optimizer, Blood Sugar Optimizer, CHEATmeals, CholesLo, Inflame & Pain Relief, LeanOptimizer, Perfect Vitamin D & K, and ProVanax 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 list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the 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 the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that 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 believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. 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.
Your written response should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human andAnimal Foods Division West 5
19701 Fairchild Irvine, CA 92612
Refer to Unique Identification Number CMS 608729 when replying.
If you have any questions regarding this letter, please contact Kimberly M. Lichter, Compliance Officer, at kimberly.lichter@fda.hhs.gov or
(949) 608-2967
.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations –West Division 5
cc: regulatory-inquiries@amazon.com
Content current as of:
10/06/2020
Regulated Product(s)
Drugs
Food & Beverages