On November 5, 2019, the FDA updated its 2017 safety communication to remind patients, healthcare professionals, and laboratory technicians that levels of biotin or B-7, a B-complex vitamin and a common component of dietary supplements, higher than the recommended daily allowance may interfere with lab test results.
Many dietary supplements promoted for hair, skin, and nails contain biotin levels up to 650 times the recommended daily intake of biotin. Physicians may also recommend high levels of biotin for patients with certain conditions such as multiple sclerosis. Biotin levels higher than the recommended daily allowance may cause interference with lab tests.
In its most recent update, the FDA reminds the public, healthcare providers, lab personnel, and lab test developers that biotin, often found in dietary supplements, can cause clinically significant incorrect lab test results. The FDA has seen an increase in the number of reported adverse events, including one death, related to biotin interference with lab tests. Incorrect test results may lead to inappropriate patient management or misdiagnosis. Biotin in patient samples can cause falsely high or falsely low results, which may lead to inappropriate patient management or misdiagnosis. For example, a falsely low result for troponin, a clinically important biomarker to aid in the diagnosis of heart attacks, may lead to a missed diagnosis and potentially serious clinical implications.
Consumers are advised to tell their doctor if they are taking biotin. Healthcare providers should talk to their patients about any biotin supplements they may be taking. Know that biotin is found in multivitamins – including prenatal multivitamins, biotin supplements, and dietary supplements for hair, skin, and nail growth – at levels that may interfere with lab tests. Lab personnel using assays with biotin technology must educate themselves and others about the potential for biotin interference.
The recommended daily allowance of biotin is 0.03 mg and biotin is present in small amounts in many foods including whole grains, eggs, walnuts, avocados, egg yolk, liver, and yeast.
Forms for healthcare professionals and patients to report safety information:
FDA Safety Communication:
Under the oaks and evergreens at 7420 feet
Wild strawberry runs along the trail. Tea of strawberry leaves and stems is valued for its mild astringent effects, and its antirheumatic, diuretic, antidiarrheal, tonic, and laxative properties. Strawberry is recommended in many traditions for intestinal sluggishness and for pregnancy, convalescence, and chronic stomach sensitivity when stronger herbs are contraindicated.
Known variously as 艾叶 (aiye), artemisia, or mugwort, wormwood is an intense bitter that stimulates underactive digestion and aids anemia. An anti-inflammatory and antidepressant, wormwood can be added as a potentiating factor to other preparations. Its active substances include essential oils, sesquiterpene lactones, azulenes, flavonoids, phenolic acids, and lignans. The whole plant is used as an antimalarial. Wormwood herbal tea is administered as a stomach stimulator and orexigenic.
In Chinese medicine, wormwood warms the channels and stops bleeding. It dispels cold and alleviates pain, calms the fetus, resolves phlegm, and stops cough and asthma. As an aromatic, wormwood is used in sweat baths and saunas. Wormwood-juniper smudge sticks cleanse spaces and purge negativity.
The constituents of verbena or 马鞭草 (mabiancao, literally, horsewhip herb) include volatile oils, bitters, iridoids, alkaloids, mucilage, and tannins. It is a restorative, helpful for tension and long-term stress and good for convalescence from a long illness. The entire plant has sedative, tonic, diaphoretic, and anti-inflammatory properties and it is used to treat early-stage depression, melancholia, stress, and fever. Chinese medicine employs the bitter and cool properties of verbena to clear heat and remove toxicity, activate blood, disperse nodules, promote diuresis, and resolve swelling. It is indicated for jaundice caused by damp-heat, for fever due to external pathogens, and for dysmenorrhea or amenorrhea from blood stasis and abdominal masses. Its heat-clearing properties are used for severe sore throat and other accumulations of heat toxin including breast abscesses and swollen and painful gums. Extracts of lemon verbena and its major compound acteoside (ACT) have a regulatory effect on abnormal liver lipid metabolism; furthermore, ACT promotes lipolysis and fatty acid oxidation by increasing messenger RNA expression of adipose triglyceride lipase and carnitine palmitoyltransferase.
The leaves, acorns, galls, and branches of oak trees contain tannin, quercetin, gallic acid, pectin, calcium, magnesium, and potassium. In various medical traditions, infusion of oak tree bark is administered internally to treat hemorrhoids, diarrhea, chronic dysentery, intestinal bleeding, and uterine bleeding, and, as a tea astringent, oak is applied externally to skin wounds, burns, mouth inflammation, toothaches, sore throats, and earaches.
Oak gall possesses astringent, anti-inflammatory, antiviral, antidiabetic, larvicidal, antibacterial, and gastroprotective effects. Gallnuts have been sourced to produce drug therapies for cancerous diseases in traditional and folk medicine systems through the centuries, and the literature indicates that gallnuts contain a number of bioactive metabolites, accounting for their anticancer effects. Further screening of bioactive compounds is expected to yield valuable anticancer agents.
The medicinal evergreen juniper or 杜松子(dusongzi) is resinous and aromatic. Internally, the leaves or berries have been used as a urinary antiseptic and for cystitis and urethritis, although juniper is contraindicated in people with kidney infection or chronic kidney weakness as the oils may be irritating to kidney inflammations. Juniper berries have diaphoretic and emmenagogue properties and the leaves have diuretic properties. In Chinese medicine, juniper works at the heart, spleen, and lung meridians and its key actions and medicinal uses include promoting digestion, warming the middle burner, expelling phlegm, warming the lungs, and cleansing the kidneys and liver.
Topically, juniper is used to treat chronic skin irritations and as a relaxant. It relaxes the muscles and removes barriers to blood flow and energetic flow. Juniper is prized in many traditions for its ability to dispel tension and stagnation and the aromatic parts of the juniper plant have been employed as a protector against negativity. Juniper is known to have a stabilizing presence for those in need of safety and protection.
Juniper's versatility extends to the culinary world and includes the flavoring of meat and sauerkraut and the distillation of gin.
Please note: The herb information in this blog is presented for educational purposes only. The use of herbal preparations is not recommended without seeking the advice of a healthcare provider. Substances in herbal preparations may interact with prescription drugs to eliminate therapeutic efficacy or induce toxicity.
Identifying local herbs
Bear corn or 肉苁蓉 (roucongrong) emerges from the soil under the oaks. A root parasite lacking chlorophyll, bear corn searches the dark soil to feed off the root system of the host tree. These New Mexico specimens are yellow and resemble ears of corn. In the words of Culpeper, “The juice or decoction of the young branches or seed, or the powder of the seed taken in drink, purgeth downwards and draweth phlegmatic and watery humors from the joints, whereby it helpeth the dropsy, gout, sciatica, and pains in the hips and joints.” Bear corn serves as an astringent, a poultice, a laxative, and a sedative. It restores strength, muscle tone, and balance after a long illness. In Chinese medicine, bear corn is a tonic to kidney-yang and a demulcent laxative; it tonifies yin as well as yang, lowers blood pressure, and is prized as an aphrodisiac and a uterine hemostatic. Modern research indicates that phenylethanoid glycosides isolated from bear corn may be effective in treating hot flashes and menopausal syndrome.
The wet spring has produced a bumper crop of fernlike yarrow. Also known as thousand-leaf, yarrow is an important species in the traditional medicine of many cultures. It is antispasmodic, astringent, bitter, diaphoretic, and anti-inflammatory, and its constituents include coumarins, tannins, alkaloids, flavonoids, lactones, volatile oils, and triterpenes. Internally, yarrow is used to break fevers and to regulate the menstrual cycle, reduce heavy bleeding, and relieve menstrual pain. Externally, a salve or ointment of yarrow heals wounds and eases the pain of varicose veins. Yarrow has been used as a battlefield remedy for its ability to stanch bleeding and its antibacterial properties. Soldiers applied powdered yarrow or fresh yarrow leaves and flowers to stop wounds from bleeding.
Clematis or 威灵仙 (weilingxian) grows vertically on rocky roots as a vine with sparse, four-petal, nodding mauve flowers. Clematis has analgesic, anti-inflammatory, diuretic, and antimicrobial properties and its synergistic nature increases the effectiveness of other herbs. Clematis tea both acts as a vasoconstrictor on brain lining and dilates blood vessels -- it is used to treat headaches and migraines. Externally, a poultice of clematis leaves treats rheumatic pain.
Known as “the holy root of the temple” in Chinese medicine, clematis removes wind and dampness, facilitates passage of meridians, and relieves pain. Experimental studies have demonstrated the antirheumatic and analgesic effects of clematis and saponins isolated from clematis may induce apoptosis in breast cancer cells via the mitochondrial pathway. Triterpene saponins from the roots and rhizomes of Clematis mandshurica show inhibitory activity against human colon cancer cell lines.
Valerian or 缬草 (xiecao) clings to the rocks nearby. Also known as all-heal, valerian's use as a medicinal herb was documented in ancient Greece. Pliny said that the powder of valerian root given in drink, or the decoction thereof taken, helps all stoppings and stranglings in any part of the body. And Culpeper recommended the root of valerian boiled with licorice, raisins, and aniseed as singularly good for those who are short-winded and for those who are troubled with the cough, to open passages and expectorate phlegm easily.
We scratch the root and smell the pungent odor of its chemical constituent valerenic acid. Acting at the central nervous system, valerenic acid and its derivatives have soothing, sedative, spasmolytic, digestive, and hypnotic properties. Physiologically active iridoid valepotriates may cause the release of GABA from nerve endings and block its return to nerve cells, and valerenic acid is known to inhibit an enzyme that destroys GABA. Herbal tea from valerian root has been used for anxiety, tension, hysteria, insomnia, and pain. Valerian root is approved in Europe for mild anxiety and to aid sleep.
In Chinese medicine, valerian possesses pungent, bitter, and warm properties and enters through the liver and heart meridians. It acts to induce tranquilization, stop bleeding, and alleviate pain. Valerian root is indicated for irregular menstruation, traumatic injury, back pain, neurasthenia, and indigestion.
Corydalis, also known as golden smoke, scrambled egg, or 延胡索 (yanhusuo), is among the first herbs to flower in spring. An herbal tea of the fumewort corydalis has hypnotic and analgesic properties and is used for stomachache and headache. The Ojibwe people placed the root on coals and inhaled the smoke to clear the head and calm the patient. In Chinese medicine, corydalis invigorates the blood, moves qi, alleviates pain, and reduces masses; thus, it is indicated for pain due to blood stasis and qi stagnation such as epigastric pain and dysmenorrhea. Corydalis contains 20 alkaloids, among them corydaline, tetrahydropalmatine, protopine, and tetrahydrocoptisine, and in laboratory research has exhibited pharmacological action on the central nervous system, including analgesic and sedative effects. Corydalis may block certain receptor sites in the brain, inducing sedation. Its alkaloids may also have cardiovascular effects.
Please note: The herb information in this blog is presented for educational purposes only. The use of herbal preparations is not recommended without the advice of a healthcare provider. Substances in herbal preparations may interact with prescription drugs to eliminate therapeutic efficacy or induce toxicity.
Just 24 minutes outside the city of Albuquerque in the East Sandia Mountains of New Mexico, at an elevation of 7420 feet, the wet winter and cold spring have yielded a bounty of herbs. Our guide points out filaree, mullein, hawthorn, dandelion, bear corn, yarrow, clematis, valerian, corydalis, strawberry, wormwood, and verbena among the pines and oaks along the trail.
Information in this blog is presented for educational purposes only. Not intended to diagnose, treat, cure, or prevent any disease. The use of herbal preparations is not recommended without seeking the advice of a healthcare provider. Substances in herbal preparations may interact with prescription drugs to eliminate therapeutic efficacy or induce toxicity.
The U.S. Food and Drug Administration is advising consumers not to purchase or use LOBO, Love in S, Sheaya Lender, and Mero Macho sold and advertised as dietary supplements. FDA has identified an emerging trend in which over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you!
This product promoted for sexual enhancement was identified in an examination of international mail shipments. The red LOBO text and fierce wolf image resemble the mascot of the University of New Mexico, and package copy in Spanish states Maximiza tu potencia sexual – Doble dosis de poder (Maximize your sexual potency – double dose of power). The Food and Drug Administration is advising consumers not to purchase or use LOBO, which contains sildenafil, the active ingredient in the prescription drug Viagra. This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.
Mero Macho is sold on the websites fitoterapiausa.com and meromachodrink.com (both sites are currently under construction). FDA laboratory analysis confirmed that Mero Macho contains tadalafil, the active ingredient in the prescription drug Cialis, used to treat erectile dysfunction. Adverse reactions noted in the Cialis prescribing information include headache, indigestion, back pain, myalgia, nasal congestion, flushing, and limb pain. Contraindications are organic nitrates (tadalafil potentiates the hypotensive effect of nitrates), patients with known serious hypersensitivity to tadalafil, and concomitant guanylate cyclase stimulators. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
FDA is advising consumers not to purchase or use Sheaya Lender, a product promoted for weight loss. This product was identified during an examination of international mail shipments. FDA laboratory analysis confirmed that Sheaya Lender contains sibutramine and fluoxetine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. This product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or heart rate in some people and may present a significant risk for people with a history of coronary artery disease, congestive heart failure, arrhythmia, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
Fluoxetine is an FDA-approved drug in a class of drugs called selective serotonin reuptake inhibitors (SSRIs) used for treating depression, bulimia, obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder. The use of SSRIs has been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. Ventricular arrhythmia or sudden death can occur when patients are also taking other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis).
Love in S
FDA is advising consumers not to purchase or use Love in S, a product promoted and sold for weight loss. The package has the torso of a fit woman, images of fruits and other plants, and the words “love in S lose inches Natrually.” FDA laboratory analysis confirmed that Love in S contains sibutramine and N-desmethylsibutramine. N-desmethylsibutramine is structurally similar to sibutramine (as described above, sibutramine is a controlled substance that has been removed from the market).
“These products are masquerading as dietary supplements — they may look like dietary supplements but they are not legal dietary supplements,” says Michael Levy, director of FDA’s Division of New Drugs and Labeling Compliance. “Some of these products contain hidden prescription ingredients at levels much higher than those found in an approved drug product and are dangerous.” FDA has received numerous reports of harm associated with the use of these products, including stroke, liver injury, kidney failure, heart palpitations, and death.
Dietary Supplements and the FDA
Dietary supplements, in general, are not FDA-approved. Under the Dietary Supplement Health and Education Act of 1994, dietary supplement firms do not need FDA approval prior to marketing their products. It is the company’s responsibility to make sure its products are safe and that any claims are true.
Just because you see a supplement product on a store shelf does NOT mean it is safe or effective. When safety issues are suspected, FDA must investigate and, when warranted, take steps to have the product removed from the market. However, it is much easier for a firm to get a product on the market than it is for FDA to take a product off the market. FDA has worked with the supplement industry to recall numerous products with potentially harmful ingredients including products marketed for weight loss, products marketed for sexual enhancement, and products marketed for body building. The agency has issued warning letters, seized products, and conducted criminal prosecutions. In December 2010, a woman pleaded guilty to an 18-count indictment charging her with the illegal importation and distribution of more than four million diet pills that contained a controlled substance, unapproved drugs, and a possible cancer-causing agent.
These hidden ingredients pose a risk to consumer health. Remember, FDA cannot test all products marketed as dietary supplements to identify those containing potentially harmful hidden ingredients. Consumers must be aware of these dangerous products and learn how to identify and avoid them using the warning signs described below.
Advice for Consumers
What can you do? Be an informed consumer. Know the source of the dietary supplements you buy. Read the label information. Subscribe to FDA notifications informing the public of products marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” Consumers should exercise caution before purchasing any product in the above categories.
“We need consumers to be aware of these dangerous products and to learn how to identify and avoid them,” says Levy. Consumers should look for potential warning signs of tainted products marketed as dietary supplements, such as products claiming to be alternatives to FDA-approved drugs or to have effects similar to prescription drugs, products claiming to be a legal alternative to anabolic steroids, products marketed primarily in a foreign language, products with typographical errors in the label information, or products marketed through mass emails. Beware of sexual enhancement products promising rapid effects, such as working in minutes to hours, or long-lasting effects, such as working for 24 to 72 hours. Generally, if you are using or considering using any product marketed as a dietary supplement, FDA suggests that you check with your healthcare professional or a registered dietician about any nutrients you may need in addition to your regular diet. Ask your healthcare professional for help distinguishing between reliable and questionable information. Ask yourself if it sounds too good to be true. Be cautious if the claims for the product seem exaggerated or unrealistic. Watch out for extreme claims — “quick and effective,” “cure-all,” “can treat or cure diseases,” or “totally safe.” Be skeptical about anecdotal information from personal “testimonials” about incredible benefits or results obtained from using a product.
FDA’s Medication Health Fraud webpage:
Forms for healthcare professionals and patients to report adverse events or side effects: https://www.accessdata.fda.gov/scripts/medwatch/
Responsibilities of retailers and distributors regarding tainted dietary supplements and foods: https://www.fda.gov/media/79494/download
All information current as of September 6, 2019. Information in this blog is presented for educational purposes only. Not intended to diagnose, treat, cure, or prevent any disease. The use of herbal preparations is not recommended without seeking the advice of a healthcare provider. Substances in herbal preparations may interact with prescription drugs to eliminate therapeutic efficacy or induce toxicity.
Despite the fact that it is a common condition, postoperative constipation or ileus remains poorly understood and has no established definition, etiology, or treatment. In an attempt to find a solution that quickly restores normal contractile movement of the intestines after surgery, researchers at the University of Texas used a rat model to demonstrate the in vivo and in vitro effects of coffee on gut microbiota and smooth muscle contractility.
They fed coffee to rats directly and mixed coffee with gut bacteria in petri dishes. Their findings indicated that coffee suppressed bacteria and increased muscle motility. After the rats were treated with coffee, total bacteria count in feces decreased and the ability of the muscles in the small intestine to contract increased. Xuan-Zheng Shi, lead author of the study, pointed out “Interestingly, these effects are caffeine-independent, because caffeine-free coffee had similar effects as regular coffee.”
The investigators in Shi’s study observed changes in bacteria when fecal matter was exposed to coffee in a petri dish and changes in rat feces after the ingestion of different concentrations of coffee over three days. Changes to smooth muscles in the intestine and colon and the response of muscles exposed directly to coffee were documented. Muscles in the lower intestine and colon contracted more readily after a period of coffee ingestion. In petri dishes, the growth of bacteria and other microbes in fecal matter was suppressed when a solution of 1.5 percent coffee was applied and growth slowed further with a 3 percent solution. As Shi noted above, decaffeinated coffee had a similar effect on the microbiome.
Researchers have yet to identify the specific mechanism by which coffee increases bowel movement. Further study is necessary to determine whether the decline in total bacteria count in feces helps good bacteria or bad bacteria. Favorable bacteria such as Firmicutes are relatively more efficient at breaking down complex carbohydrates, including cellulose, pectin, and xylan as well as host-derived carbohydrates at the protective mucous layer of the intestine. Increasing the ratio of these bacteria in the gut microbiome leads to higher efficiency in the storage of metabolic byproducts.
Additional clinical research is needed to ascertain whether coffee intake is effective for ileus, a temporary arrest of normal contractile movement of the intestines caused by abdominal surgery. A poorly understood postoperative outcome with mechanisms that are neurogenic, inflammatory, and pharmacological in nature, ileus presents significant clinical challenges and lacks effective management strategies. Failure to restore adequate bowel function after surgery causes complications, including infection and intestinal adhesion, which may prolong hospitalization and increase patient distress. Coffee therapy may hold some hope.
Kerilyn Sappington is the founder of Integrative Translations, which specializes in Chinese-to-English medical translation of conventional and complementary medicine.