WARNING LETTER
DRF LLC
MARCS-CMS 612282 —
April 21, 2021
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Dr. Farrah Agustin-Bunch
Recipient Title
Owner
DRF LLC
(b)(6), (b)(7)(C)
United States
Issuing Office:
Office of Human and Animal Foods Operations- West Division
United States
April 21, 2021
WARNING LETTER
CMS # 612282
Dear Dr. Farrah Agustin-Bunch:
This is to advise you that the Food and Drug Administration (FDA) reviewed your websites at the Internet addresses doctorfarrah.com and drfarrah.online in February and March 2021 and has determined that you take orders there for the products Boston C, Mega-Dose Vitamin C, and Pixie Dust Magnesium. We have also reviewed your Instagram social media website at instagram.com/drfarrahmd/, which directs consumers to your website doctorfarrah.com to purchase your products. The claims on your websites 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 that provide evidence that your products are intended for use as drugs include:
On your webpage “The Science Of Boston C” (https://doctorfarrah.com/2019/07/01/the-scienceof-boston-c/):
Claims about Boston C:
 “Boston C was the cornerstone of the treatment protocols at my facility in the Philippines where I treated 150,000 patients for all manner of illnesses over the course of 16 years.”
 “…Boston C was demonstrated to be highly effective against numerous cancer cell lines….”
 “…Boston C was tested at St. Luke’s Medical Center and declared by St. Luke’s personnel to be effective against cancer….”
 “My opinion is that the vast number of degenerative illnesses that we see have a significant nutritional causative component. Further, I believe that when these nutritional issues are properly and consistently addressed through the use of a product such as Boston C, that a patient has the opportunity to return to health….”
Claims about ingredients in Boston C (e.g., vitamins, selenium, methyl-sulfonyl-methane (MSM), blackstrap molasses, and micronutrients generally):
 “Recent evidence has shown that suboptimal levels of vitamins, even well above those causing deficiency syndromes, are risk factors for chronic diseases such as cardiovascular disease, cancer, and osteoporosis…”
 “Numerous studies have reported that higher micronutrient consumption results in a significantly lower cancer risk”
 “‘…our findings strongly suggest that at high intakes, these micronutrients exhibit independent associations in both whites and African Americans consistent with 30–70% reductions in colon cancer risk.’”
 “The available clinical data suggest that micronutrient supplementation can reduce the risk and severity of infection and support a faster recovery….”
 “Micronutrients effectively control multiple steps in breast cancer.”
 “In relation to micronutrient mixtures, a ‘synergistic micronutrient mixture has been shown to be effective against multiple targets in cancer development and progression.’”
 “In relation to Selenium, (which Boston C contains) the major effects of supplementation have been observed in the incidences of colorectal, lung, and prostate cancers along with a drastic decrease in the total cancer mortality by 50%. Study results have … provided evidence that taking a multivitamin/mineral preparation can improve … the prognosis of patients with cancer. For example, a study carried out at the Mayo Clinic (USA) of 1129 patients with lung cancer showed that mortality was reduced by 26% in patients taking a micronutrient preparation compared with those not taking any such supplements.”
1
 “It’s been demonstrated that MSM is … anti-inflammatory, … immunomodulative, and anti-cancer.”
 “MSM has been shown to improve inflammation in a number of conditions. For example, MSM attenuated cytokine expression in vivo for induced colitis, lung injury, and liver injury. MSM has been shown to help with liver injury due to acetaminophen. ‘Our findings suggest that MSM pretreatment could alleviate hepatic injury induced by acetaminophen intoxication….’”
 “In a physician’s review of clinical case studies, MSM was an effective treatment for four out of six patients suffering from interstitial cystitis. Additionally, MSM is also suggested to alleviate the symptoms of seasonal allergic rhinitis.”
 “An emerging area of MSM research deals with the anti-cancer effect of the organosulfur compound.”
 “MSM independently has been shown to be cytotoxic to cancer cells by inhibiting cell viability through the induction of cell cycle arrest, necrosis, or apoptosis.”
 “Methylsulfonylmethane (organic sulfur) induces apoptosis and decreases invasiveness of prostate cancer cells.”
 “‘Based on all these results from our study, we strongly recommend the use of MSM as a trial drug for treating breast cancers because of its multi-targeting mechanism.’ ‘In conclusion, our results show for the first time that MSM induces apoptosis in HCT-116 colon cancer cells regardless of their p53 status.’ ‘Taken together, all the results suggest that MSM has anti-cancer effects through inducing apoptosis in liver cancer.’”
 “In studies with osteoarthritic populations given MSM daily, significant improvements in physical function were observed.…”
 “‘Our results support previous anecdotal reports that intervention with MSM on elderly patients suffering from OA [osteoarthritis] is beneficial….’”
 “Patients with OA of the knee taking MSM for 12 weeks showed an improvement in pain and physical function.”
 “Methylsulfonylmethane (MSM), the isoxidised form of dimethyl-sulfoxide (DSMO), is an effective natural analgesic and anti-inflammatory agent. MSM has been shown to effect inflammatory conditions such as rheumatoid arthritis and lupus.”
 “‘Methylsulfonylmethane (MSM) … is expected to relieve inflammation in arthritis and allergies…Intake of MSM for 13 weeks decreased degeneration of the cartilage at the joint surface in the knee joints…’”
 “We chose this method of using a nutrient dense natural sugar as a carrier due to cancer cells being sugar metabolic….”
 “In theory, sugar-loving cancer cells are tricked into taking in everything else in Boston C when they gobble up the molasses. ‘Recent data on cane molasses appear to lend support to historical accounts concerning its effectiveness as both preventative and a possible curative agent for some cancer.’”
 “Blackstrap molasses is rich in a variety of essential minerals including iron, zinc, selenium, magnesium and potassium as well as the majority of the vitamin B complex, deficiencies of which confer a major cancer risk. Molasses also contains high concentrations of amino acids and linoleic acid, an essential lipid that has a documented anti-tumor effect.”
On your webpage “The science supporting Mega-dose Vitamin C” (https://doctorfarrah.com/2020/12/30/the-science-supporting-mega-dose-vitamin-c/):
 “Shown to help prevent colds & flu…”
 “…good for immunodeficiency, chronic toxin or infectious problems”
 “Good for histamine intolerance”
 “High dose vitamin C has anti-cancer effects”
 “Vitamin C May Combat Cancer & Ease Cancer Treatment”
 “Numerous reports suggest that high-dose Vitamin C has anticancer effects. High-dose Vitamin C is reportedly more toxic to cancer than it is to normal cells and induces death of various types of cancer cells including mesothelioma, pancreatic, and leukemia cells.”
 “High dietary Vitamin C has been reported to reduce gastric cancer risk.”
 “Higher dietary Vitamin C intake before breast cancer diagnosis increased the chances of survival.”
 “Men with low Vitamin C levels have been reported to have a 62% higher risk of dying from cancer. Vitamin C has been shown to lower pain and reduce the toxicity of some anticancer agents by reducing oxidative stress. Vitamin C has been reported to alleviate a number of cancer and chemotherapy-related symptoms, such as fatigue, insomnia, loss of appetite, nausea, and pain. Vitamin C is reported to improve the quality of life for cancer patients, including reduced pain and the need for painkillers, both in the presence and absence of chemo- and radiotherapy.”
 “Many infections were reported to lead to reduced Vitamin C levels. Vitamin C allegedly increases the functioning of various white blood cell types and decreases the replication of viruses. Vitamin C reportedly reduces the duration and severity of the common cold.”
 “Vitamin C potentially reduces the incidence of pneumonia. Vitamin C reportedly decreased the duration and severity of respiratory infections in male swimmers. Vitamin C reportedly eradicates H. pylori infection in 30% of patients treated, which is a precursor for ulcers. Vitamin C Has Been Reported To Help Reduce Inflammation. Vitamin C reportedly reduces inflammation by lowering inflammatory cytokines. Vitamin C can reportedly alleviate inflammation in patients with obesity, diabetes or high blood pressure.”
 “Vitamin C was shown to improve gut tolerability to aspirin and other non-steroidal anti-inflammatory drugs in this study (NSAIDs).”
 “Vitamin C also supposedly prevents neuronal damage.”
 “Many studies have found that Vitamin C can reduce the severity of depressive disorders in both children and adults….”
 “In a trial including depressed shift workers, Vitamin C significantly decreased depression severity.”
 “Poor Vitamin C status is associated with increased symptoms of depression following an acute illness in older people.”
 “Vitamin C has been shown to increases [sic] the effectiveness of antidepressants. Patients treated for six months with fluoxetine and Vitamin C showed a significant decrease in depressive symptoms compared to the fluoxetine plus placebo group according to studies.”
 “Chronic low Vitamin C status in humans is allegedly associated with neurodegenerative disorders.”
 “Vitamin C levels were significantly lower in elderly people suffering from different kinds of dementia as per this study.”
 “Supplementation with Vitamin C reduces the risk of Alzheimer’s disease in humans according to this study.”
 “Vitamin C May Improve Blood Pressure. Vitamin C significantly lowered systolic and diastolic blood pressure in patients with mild-to-moderately high blood pressure according to the authors of this study.”
 “According to some studies, high-dose Vitamin C can prevent or restore impaired blood flow caused by reactive oxygen species (ROS), preserve the integrity of the blood vessel barrier, and strengthen antibacterial defenses.”
 “Vitamin C plays a positive role in reversing the earliest stages of hardening of the arteries. Vitamin C deficiency may result in decreased blood vessel integrity, e.g. through decreased NOS generation and impaired synthesis of mature collagen. This might lead to increased plaque formation and incidence of stroke.”
 “This study further demonstrated that Vitamin C has been associated with a lower prevalence of obesity….”
 “Vitamin C is Beneficial for Diabetics”
 “Vitamin C protects against diabetic blindness…. Vitamin C may benefit patients with type 2 diabetes by decreasing blood glucose and lipids.”
 “Higher Vitamin C intakes were associated with a lower risk of osteoporosis in Korean adults aged over 50 with low levels of physical activity.”
 “Vitamin C May Protect from Stroke”
 “In humans, higher Vitamin C levels are associated with a lower likelihood of stroke.”
 “Post-operative atrial fibrillation (abnormal heart rhythm) was prevented after cardiac surgery by vitamin C supplementation.”
 “Regarding AIDS (Acquired Immune Deficiency Syndrome), ‘Ascorbate does ameliorate the AID syndrome to a significant degree. I want to emphasize, however, the absolute necessity of massive doses.’”
 “Patients receiving kidney dialysis are prone to deficiency of Vitamin C. Schizophrenic patients tend to have significantly lower levels of blood Vitamin C.”
On your webpage “The Science supporting Pixie Dust Magnesium” (https://doctorfarrah.com/2019/07/01/the-science-supporting-pixie-dust-magnesium/):
 “‘Doctors eagerly prescribe expensive patented drugs, while low-cost nutrients like magnesium remain overlooked. If the 68% of Americans who are magnesium deficient took corrective action, the need for many of these prescription drugs would be reduced.’”
 “Magnesium deficiency in Western societies has been linked to insulin resistance, type II diabetes, metabolic syndrome, coronary heart disease, colorectal cancer, and colorectal adenoma. ‘Low Magnesium intakes and blood levels have been associated with type 2 diabetes, metabolic syndrome, elevated C-reactive protein, hypertension, atherosclerotic vascular disease, sudden cardiac death, osteoporosis, migraine headache, asthma, and colon cancer.’”
 “‘Although the evidence is still fragmentary, most of the data available point to Magnesium as a chemopreventive agent…’ In a study with 1,200 lung cancer patients and a similar number of controls, low dietary Magnesium intake was associated with reduced lung cancer risk.”
 “‘Our findings support the hypothesis that higher intakes of dietary Magnesium are associated with lower risk of colorectal tumors.’”
 “‘...it seems that Mg has a cytotoxic effect against breast cancer cells…Mg can be considered as a supplement agent in the treatment of breast cancer patients….’”
 “‘Our finding indicates that higher blood Magnesium levels are associated with a lower risk of high-grade prostate cancer.’”
 “‘Magnesium was found to be lower in patients with leukemia in this study”
 “Low Magnesium intake is linked to chronic inflammation, which is one of the drivers of cancer, … obesity and chronic disease.”
 “Magnesium benefits people with type 2 diabetes.”
 “Increasing Magnesium intake appears to reduce blood sugar in people with type 2 diabetes. A meta-analysis of
eight studies
showed that taking a Magnesium supplement significantly reduced fasting blood sugar levels in participants with type 2 diabetes.”
 “Magnesium may reduce the risk of Heart Disease. Numerous studies have linked suboptimal Magnesium levels to a higher risk of heart disease.”
 “Magnesium has strong anti-inflammatory properties, may prevent blood clotting and can help your blood vessels relax to lower your blood pressure.”
 “‘There is growing evidence that Magnesium may have a role in managing asthma through its dual effect as an anti-inflammatory and bronchodilating agent.’”
 “Magnesium deficiency has a role in many diseases in addition to asthma, including migraines, depression, and epilepsy.”
 “Magnesium can help fight migraines. Many researchers believe that people who suffer from migraines are more likely than others to be deficient with Magnesium.”
 “Studies are now suggesting that Magnesium can prevent and even help treat migraines….”
 “Magnesium may help reduce the symptoms of depression.”
 “Several studies have shown that supplementing with Magnesium may reduce symptoms of depression. Some studies even found it to be as effective as antidepressant drugs.”
 “[T]hose supplementing with oral Magnesium daily … noted … decreased symptoms of insomnia.”
Your Boston C, Mega-Dose Vitamin C, and Pixie Dust Magnesium 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.
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 Boston C, Mega-Dose Vitamin C, and Pixie Dust Magnesium 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, Boston C, Mega-Dose Vitamin C, and Pixie Dust Magnesium 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)].
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 action 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.
Please send your reply to the Food and Drug Administration Dallas District Office, Attention: Rian L. Pope, Compliance Officer, 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues cited in this letter, please contact Mr. Pope at 210-308-1415 or at rian.pope@fda.hhs.gov.
Sincerely,
/S/
Edmundo Garcia Jr.
District Director | FDA Dallas District
Program Division Director
Office of Human and Animal Foods
Operations- West Division
cc: Lori Woznicki, Food and Drug Inspections Branch
Manager, Division of Regulatory Services
Texas Department of State Health Services
1100 W. 49th Street
Austin, TX 78756
_______________________________
1
Here and throughout the remainder of the letter, citations have been removed where they appear on your website.
Content current as of:
06/22/2021
Regulated Product(s)
Food & Beverages