Natural Standard Blog

FDA: Three Sex Enhancement Products Contain Hidden Ingredients

The U.S. Food and Drug Administration (FDA) recently issued consumer warnings for several sexual enhancement products.

These products include Lightning ROD, Vicerex, and Bullet Proof.

Lightning ROD contains the undeclared ingredient hydroxythiohomosildenafil. This ingredient has a structure similar to that of sildenafil, the active ingredient in the FDA-approved drug Viagra. Vicerex and Bullet Proof both contain the undeclared ingredient tadalafil. Tadalafil is the active ingredient in the FDA-approved drug Cialis.

These undeclared ingredients may interact with nitrates, which are found in some prescription drugs, and may lower blood pressure to dangerous levels. Men who have conditions such as diabetes, heart disease, high blood pressure, or high cholesterol often take nitrate-containing prescription medications.

The FDA advises consumers in possession of Lightning ROD, Vicerex, or Bullet Proof to discard them immediately and report any side effects to a healthcare provider. Side effects associated with these products should also be reported to the FDA's Medwatch Safety Information and Adverse Event Reporting Program.

For more information about erectile dysfunction, please visit Natural Standard's Medical Conditions Database.

FDA Proposes Adding Selenium to Infant Formula Nutrient Requirements

The U.S. Food and Drug Administration (FDA) is proposing to update current regulations on infant formula with the addition of selenium to the list of required nutrients.

Selenium is an essential trace mineral found in soil, water and some foods. It is a component of the amino acids cysteine and methionine. Selenium is required for functioning of the body's antioxidant enzymes and for cell growth and survival.

According to the Federal Food, Drug, and Cosmetic Act (FFDCA), infant formula is defined as food that serves a special dietary purpose as a complete or partial substitute of human breast milk. The FDA requires infant formula to have minimum amounts of 29 nutrients and also maximum amounts of nine of these nutrients. In addition, there are many components that are also added to enhance the beneficial effects of infant formula, such as emulsifiers and stabilizers, docosahexaenoic acid (DHA), arachidonic acid (ARA), probiotics, prebiotics, taurine, L-carnitine, choline, inositol and biotin (vitamin B7).

In the recently proposed rule, the FDA states that at the time nutrient regulations for infant formula were initially established, selenium was not recognized as an essential nutrient. Currently, selenium is known to be a nutritional trace mineral that plays an important role in detoxification and antioxidant defense in the body. While selenium is not currently a required nutrient in infant formula, all formals that are manufactured in the United States do include the mineral. Additionally, the Food and Nutrition Board of the National Research Council established a Recommended Dietary Allowance (RDA) for selenium for infants in 1989.

After reviewing the available evidence on selenium intake in infants, the FDA proposes that a minimum of 2 micrograms selenium be required per 100 kilocalories of infant formula, with a maximum of 7 micrograms per 100 kilocalories of formula. This proposal would also add selenium to the list of nutrients that must be included on nutrition labels of infant formula.

By updating the regulations, the FDA hopes to maintain safe nutrient levels for both formula products made in the United States and international products that aim to enter the US market.

To read the full proposal, please visit www.federalregister.gov.

For more information about selenium, please visit Natural Standard's Foods, Herbs & Supplements Database.

Harmful Effects Linked to Bitter Orange and Caffeine

Some products sold as sports or weight loss supplements may contain synephrine, which may enhance the effects of caffeine, according to the Federal Institute for Risk Assessment (BfR).

Synephrine is a compound found in plants such as bitter oranges (Citrus aurantium). Bitter orange comes from a flowering, fruit-bearing evergreen tree native to tropical Asia, but is now widely cultivated in the Mediterranean region and elsewhere. Bitter oranges have been used in ancient Chinese medicine to treat constipation, improve energy, and calm nerves in cases of insomnia and shock. Amazon rainforest tribes have used bitter orange tea as a laxative and to relieve nausea, stomach pains, indigestion, gas, and constipation.

According to BfR, sports or weight loss supplements often contain caffeine in addition to synephrine and are often referred to as food supplements or dietetic foods by manufacturers. Because caffeine and synephrine both affect the heart and blood pressure, they may increase each increase the other's effects when taken together. Most notably, taking caffeine and synephrine together may increase heart rhythm and blood pressure. Other ingredients contained in bitter orange extracts may also add to the effects of synephrine on the heart.

The BfR recommends that quantities of these compounds ingested through such products should be limited to food intake levels from oranges and bitter oranges. The institute advised that no more than 6.7 milligrams of synephrine be taken daily in the form of a food supplement. This quantity of synephrine may help ensure that even frequent consumers do not exceed a total daily intake of more than 25.7 milligrams of synephrine.

Due to dosage levels, some products that are currently available on the market may be classified as unsafe. The effects of these products on the heart may be more intense in people who are already putting increased strain on the heart due to physical activity or being overweight.

It is claimed that bitter orange is an effective aid to weight loss and a safe alternative to ephedra, a plant that contains compounds that may stimulate the nervous system. In 2004, the U.S. Food and Drug Administration (FDA) issued a final rule prohibiting the sale of dietary supplements containing ephedra because such supplements present an unreasonable risk of illness or injury. Due to the ban on ephedra in the United States, some products previously containing ephedra have been reformulated to include Citrus aurantium.

For more information about bitter orange, please visit Natural Standard's Foods, Herbs & Supplements Database.

NEW Recipe Database Search Interface

Natural Standard is pleased to announce the availability of a new advanced search interface within the increasingly popular Recipe Database.

In addition to regular exercise, well-balanced meals and sensible portions are important to overall health. The Natural Standard Recipe Database, launched in May 2012, features a wide range of healthy recipes in the following categories: Beans & Legumes, Dairy, Eggs, Fruit, Meat, Pasta, Poultry, Rice & Grains, Seafood, Vegetables and Nuts, Fats & Oils.

Each recipe provides details on preparation time, difficulty, special diet and nutrition information, as well as direct links to Natural Standard evidence-based systematic reviews for studied ingredients.

The new advanced search interface allows users to quickly narrow results by various filters, including servings, cook time, difficulty, main ingredient, meal, cuisine and special diet, simplifying the search process as the database continues to grow. Users may also continue to scroll through the complete list of available recipes if desired.

To try the NEW advanced search interface, please visit Natural Standard's Recipe Database.

FDA: Male Sexual Enhancement Supplement Contains Undeclared Drug

The U.S. Food and Drug Administration (FDA) recently announced a recall for Night Bullet, a male sexual enhancement supplement manufactured by Green Planet Inc.

Laboratory tests showed that Night Bullet was falsely marketed as a supplement. Night bullet contained substances similar to sildenafil. Sildenafil is a main ingredient in erectile dysfunction drugs; thus, Night Bullet is an unapproved drug.

An interaction between sildenafil and prescription drugs containing nitrates (such as nitroglycerin) may lower blood pressure to an unsafe level. Individuals taking nitrates often have diabetes, high blood pressure or cholesterol, or heart disease.

Green Plant Inc. has recalled one lot of Night Bullet.

Any consumer in possession of lot number B43N032 of Super Power should discard the product immediately. Individuals taking this supplement should report any negative side effects to their healthcare provider and the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

For more information about integrative therapies for erectile dysfunction, please visit Natural Standard's Comparative Effectiveness Database.

Journal of Dietary Supplements: New Issue

The new issue of the Journal of Dietary Supplements (JDS) features a Natural Standard evidence-based review on Tongkat Ali (Eurycoma longifolia).

The international, peer-reviewed journal aims to help consumers and clinicians make informed decisions about the preparations, foods and botanicals that are used to improve health.

The new issue includes the following articles:

Potential Toxicity of Caffeine when Used as a Dietary Supplement for Weight Loss, by Morgan Pendleton, Stacy Brown, Christan M. Thomas, and Brian Odle.

Effects of Glycine-Arginine-α-Ketoisocaproic Acid Supplementation in College-Age Trained Females during Multi-Bouts of Resistance Exercise, by Benjamin Wax, Laura Hilton, Brad Vickers, Katherine Gilliland, and Mandy Conrad.

A Randomized, Double-Blind Clinical Study on the Safety and Tolerability of an Iron Multi-Amino Acid Chelate Preparation in Premenopausal Women, by Gameil T. Fouad, Malkanthi Evans, Prachi Sharma, Joshua Baisley, David Crowley, and Najla Guthrie.

The Efficacy of Irvingia Gabonensis Supplementation in the Management of Overweight and Obesity: A Systematic Review of Randomized Controlled Trials, by Igho Onakpoya, Lucy Davies, Paul Posadzki, and Edzard Ernst.

Chemical Composition and Biological Evaluation of Physalis peruviana Root as Hepato-renal Protective Agent, by Souad E. El-Gengaihi, Emad E. Hassan, Manal A. Hamed, Hanan G. Zahran, and Mona A. Mohammed.

An Evidence-Based Systematic Review of Tongkat Ali (Eurycoma longifolia) by the Natural Standard Research Collaboration, by Catherine Ulbricht, Julie Conquer, Kelly Flanagan, Richard Isaac, Erica Rusie, and Regina C. Windsor.

To submit a manuscript for a future issue online, please visit the mc.manuscriptcentral.com/wjds.

For more information, please e-mail jds@naturalstandard.com.

FDA: Consumer Warning for Male Sexual Enhancement Supplement

The U.S. Food and Drug Administration (FDA) recently issued a consumer warning for Super Power, a supplement for male sexual enhancement.

Manufactured by Freedom Trading, laboratory tests showed that Super Power, which was falsely marketed as a supplement, contained sildenafil, making it an unapproved drug. Sildenafil is a main ingredient in erectile dysfunction drugs.

An interaction between sildenafil and prescription drugs containing nitrates (such as nitroglycerin) may lower blood pressure to an unsafe level. Individuals taking nitrates often have diabetes, high blood pressure or cholesterol, or heart disease.

Freedom Trading has recalled one lot of Super Power.

Any consumer in possession of lot number L08108 of Super Power should discard the product immediately. Individuals taking Super Power should report any negative side effects to their healthcare provider and the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

For more information about integrative therapies for erectile dysfunction, please visit Natural Standard's Comparative Effectiveness database.

FDA Approves Botanical Drug

The U.S. Food and Drug Administration (FDA) recently approved crofelemer (Fulyzaq™) to treat diarrhea symptoms associated with antiretroviral therapy for HIV/AIDs.

This is only the second botanical prescription drug to be approved by the FDA. Sinecatechins (Veregen®) was approved as a treatment for external genital and perianal warts in 2006.

Although current antiretroviral drugs cannot cure HIV/AIDS, they may suppress the virus, even to undetectable levels. Individuals taking antiretroviral drugs frequently experience side effects such as nausea and diarrhea. According to the statement issued by the FDA, taking crofelemer (Fulyzaq™) twice daily may relieve the associated diarrhea side effects.

Crofelemer (Fulyzaq™) is derived from the red sap of the Croton lechleri plant, also called Sangre de grado. Sangre de grado (the Peruvian name) or sangre de drago (the Ecuadorian name), meaning "blood of the dragon," is a medium-sized tree that grows in the upper Amazon region of Peru, Ecuador, and Colombia. It has large, heart-shaped, green leaves and greenish-white flowers. Upon injury to the bark of the tree, a dark red resin spills out of the tree. Sangre de grado is still used in traditional medicine in South America, where it is used for hemorrhaging and wounds, and as an antiseptic. It is also used for protection against ulcers, including those of the stomach, mouth, throat, and intestines; as an antiviral, anticancer and antidiarrheal agent; and topically for skin conditions and insect bites.

For more information about sangre de grado, please visit Natural Standard's Foods, Herbs & Supplements Database.

NEW Pregnancy & Lactation Checker

Natural Standard recently launched a NEW Pregnancy & Lactation checker, an easy-to-use tool for consumers and healthcare professionals seeking safety data on integrative therapies for pregnant and breastfeeding women.

According to research presented at the International Research Congress on Integrative Medicine and Health 2012, 89.1 percent of women from the Australian Longitudinal Study of Women's Health reported taking vitamins and minerals while pregnant, of which 43.7 percent were self-prescribing. Furthermore, 53 percent of women used herbal medicine during pregnancy, while only 7.2 percent reported visiting an herbalist or naturopathic physician. Studies in the United States and United Kingdom have reported similarly high usage rates among pregnant and breastfeeding women, highlighting the need for easy access to evidence-based safety data.

This new decision-support tool allows clinicians to quickly search for safety data on specific integrative therapies that have been studied for use during pregnancy and lactation, thus opening communication between healthcare providers and patients as integrative therapy use in pregnancy continues to rise.

Natural Standard's evidence-based systematic reviews also feature pregnancy and lactation data. The new Pregnancy & Lactation Checker conveniently compiles this information in one location for easy use.

To try this new tool, please visit Natural Standard's new Pregnancy & Lactation Checker.

FDA: Iron Supplement Recall

The U.S. Food and Drug Administration (FDA) recently issued a consumer warning for Rugby Natural Ferrous Sulfate Iron Supplement, manufactured by Advance Pharmaceutical Inc.

Iron is an essential mineral and an important component of proteins involved in oxygen transport and metabolism. The World Health Organization considers iron deficiency to be the largest international nutritional disorder. A vegan diet in particular leads to a strongly increased risk of deficiencies of minerals, such as calcium, iron, and zinc.

Recently, a pharmacist found 25 milligram Meclizine Hydrochloride tablets in one of the iron supplement bottles. Meclizine Hydrochloride may lead to adverse side effects when taken with alcohol or other sedatives, and also in individuals with nervous system diseases, the elderly and nursing infants. Meclizine Hydrochloride may cause drowsiness, confusion, coma, drop in blood pressure, and difficulty breathing.

Advance Pharmaceutical Inc. recalled one lot of the iron supplements.

Any consumer in possession of lot number 12G468 of the Rugby Natural Ferrous Sulfate Iron Supplement should discard the product immediately. Any negative side effects should be reported to a healthcare provider and the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

For more information about iron supplementation, please visit Natural Standard's Foods, Herbs & Supplements database.

Many Caffeine Supplements May Have Misleading Labels

A new study suggests that supplements containing caffeine may have misleading labels.

Caffeine is a naturally occurring compound found in the leaves, seeds, or fruits of more than 60 plants, including coffee beans, cacao beans, kola nuts, guarana berries and tea leaves. Caffeine is consumed regularly in the United States and throughout the world. It is found in many beverages, including coffee, chocolate, some energy drinks, and tea.

In people, caffeine may be useful to stimulate the heart and increase urine flow. Caffeine has been shown to affect mood, endurance, the brain, and blood vessels, as well as activity in both the stomach and colon. Caffeine has also been marketed as a weight loss tool and is often included in various weight loss supplements.

In the recent study, researchers chose 31 of the most popular caffeine supplements sold as capsules, purchased from a supplement retail store. Researchers quantified the amount of caffeine in the capsules, using high-pressure liquid chromatography.

Out of the 31 supplements, only 20 products listed caffeine as an ingredient. Of the 20 supplements listing caffeine, six products did not include the amount of caffeine and five products included an inaccurate amount of caffeine.

The eleven products that did not have caffeine on the label instead listed herbs that naturally contain caffeine, such as green tea extract. Laboratory analysis showed that these eleven products had minimal amounts of caffeine, ranging from zero to three milligrams.

The researchers concluded that more accurate labeling of caffeine levels should be provided on supplements.

For more information about caffeine, please visit Natural Standard's Foods, Herbs & Supplements Database.

FDA: Consumer Warning for Weight Loss Supplement

The U.S. Food and Drug Administration (FDA) recently issued a consumer warning for the weight loss supplement MAXILOSS Weight Advanced.

The FDA found traces of sibutramine in the supplement. Sibutramine is an appetite suppressant drug that was withdrawn from the market in 2010. Thus, MAXILOSS Weight Advanced is considered an unapproved drug. This supplement has been sold online and in retail stores.

In November 2012, the FDA found sibutramine in three other weight loss supplements: Japan Hokkaido Slimming Weight Loss Pills, Beautiful Slim Body and Best Share Green Coffee: Brazilian Slimming Coffee. In December 2012, sibutramine was also discovered in Slimdia Revolution.

Sibutramine can raise blood pressure and heart rate, causing potential complications in individuals with heart disease, heart failure, arrhythmias or stroke. Sibutramine may also interact adversely with prescription drugs.

Any consumer in possession of MAXILOSS Weight Advanced should discard the product immediately. Any negative side effects should be reported to a healthcare provider and the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

For more information about integrative therapies for weight loss, please visit Natural Standard's Comparative Effectiveness Database.

FDA: Weight Loss Supplement Contains Undeclared Drug

The U.S. Food and Drug Administration (FDA) recently issued a consumer warning for the weight loss supplement Slimdia Revolution.

The FDA found traces of sibutramine in the supplement. Sibutramine is an appetite suppressant drug that was withdrawn from the market in 2010. Thus, Slimdia Revolution is considered an unapproved drug. The manufacturer P&J Trading has voluntarily recalled all Slimdia Revolution products.

In November 2012, the FDA also found sibutramine in three other weight loss supplements: Japan Hokkaido Slimming Weight Loss Pills, Beautiful Slim Body and Best Share Green Coffee: Brazilian Slimming Coffee.

Sibutramine can raise blood pressure and heart rate, causing potential complications in individuals with heart disease, heart failure, arrhythmias or stroke. Sibutramine may also interact adversely with prescription drugs.

P&J Trading is offering customers in possession of Slimdia Revolution a full refund for the unused product.

Any negative side effects should be reported to a healthcare provider and the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

For more information on integrative therapies for weight loss, please visit Natural Standard's Comparative Effectiveness Database.

Dietary Supplements May Interact With Drugs

New research highlights the potential adverse interactions between certain dietary supplements and drugs.

In the recent study, researchers evaluated 85 studies including 1,491 different supplement and drug combinations. Data analysis showed that in half of the interactions, the dietary supplements affected the drug's break down, absorption or elimination.

Researchers found the dietary supplements St. John's Wort, magnesium, calcium, iron and ginkgo had the greatest number of reported drug interactions. Drugs for the heart and nervous system had the most reported interactions with dietary supplements; these drugs included warfarin, insulin, aspirin, digoxin and ticlopidine.

The study concluded that clearer communication between patients and healthcare professionals regarding dietary supplement and drug consumption may prevent these adverse interactions.

For more information on dietary supplement and drug interactions, please visit Natural Standard's Advanced Interactions Checker.

FDA Investigates Monster Energy® Drink Safety

The U.S. Food and Drug Administration (FDA) is investigating claims that several deaths have been caused by Monster Energy®, an energy drink manufactured by Monster Beverage Corporation.

Last year, a teenage girl died after drinking two 24 ounce cans of Monster Energy® over one day. Autopsy reports showed her death was due to heart complications from caffeine toxicity. However, she had a genetic heart condition, making it unclear if her death resulted from the energy drinks.

Energy drinks are not always labeled clearly with their caffeine content. The American Academy of Pediatrics recommends that teenagers should consume 100 milligrams or less daily of caffeine. One 24 ounce can of Monster Energy® contains about 240 milligrams of caffeine, or seven times the caffeine levels in one 12 ounce can of soda.

Caffeine is a naturally occurring compound found in the leaves, seeds, or fruits of more than 60 plants. It has mood-altering properties and acts a mild diuretic. This well-known stimulant has notable effects, including increased energy, decreased perception of fatigue and improved sense of performance.

The FDA is currently evaluating the safety and dosage of the ingredients in Monster Energy®.

For more information about caffeine, please visit Natural Standard's Foods, Herbs & Supplements Database.

New Healthcare Documentaries: "Money and Medicine" and "Escape the Fire"

Natural Standard would like to share two new healthcare documentaries.

Money and Medicine: This documentary aired just last month on PBS. The documentary focuses on reducing healthcare expenditures and improving health outcomes through better coordination of patient care, shared patient decision-making, and through the practice of evidence-based medicine.

Escape the Fire: This documentary received a limited release last week and is being advertised as An Inconvenient Truth for healthcare. The documentary promotes prevention and wellness as effective alternatives to disease management.

Roger Ebert's review of Escape the Fire is available here.

Please share your thoughts.

 

MHRA: Echinacea May Be Unsafe for Children

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK recently cautioned consumers about the use of echinacea supplements in children under 12 years-old. The MHRA is a government agency that oversees the safety and effectiveness of medical devices and medicines in the UK.

Traditionally used for a range of infections and malignancies, the roots and herb of echinacea species have attracted scientific interest due to their purported immune stimulant properties. Oral preparations of echinacea are popular in Europe and the United States for the prevention and treatment of upper respiratory tract infections or the common cold.

The MHRA recommendation resulted from the conclusions of the European Herbal Medicinal Products Committee (HMPC) and from the UK Herbal Medicines Advisory Committee (HMAC). These committees reported that the risk of allergic reaction to echinacea is higher in younger children. The MHRA stated that echinacea is still safe for children over 12 and adults.

The products Echinaforce Junior Cold & Flu Tablets and Echinaforce Chewable Cold & Flu Tablets will be relabeled to reflect this recommendation. The MHRA is working to relabel other echinacea products on the market.

For more information about echinacea, please visit Natural Standard's Foods, Herbs and Supplements database.

FDA: Supplement May Contain Prescription Drug Ingredient

The U.S. Food and Drug Administration (FDA) is warning consumers that Reumofan and Reumofan Plus, currently marketed as natural dietary supplements, may contain unlabeled prescription drug ingredients with the potential to cause adverse effects.

Reumofan and Reumofan Plus are manufactured by the Mexican company Riger Naturals. The supplements are marketed as muscle and arthritis pain relievers.

The FDA found that Reumofan Plus contained Diclofenac Sodium, an anti-inflammatory drug that increases the risk of heart attack and other complications in the stomach and intestines. In Reumofan Plus, FDA laboratories also discovered methocarbamol, a muscle relaxant and dexamethasone, a drug that suppresses the immune system.

The FDA has also received reports of several mild and serious side effects, including liver injury, uncontrolled sugar levels, weight gain, swelling, cramping in the legs and kidney dysfunction (adrenal suppression).

According to the statement issued by the FDA, individuals currently taking Reumofan Plus or recently stopped taking Reumofan Plus should immediately consult a healthcare professional. The drugs in Reumofan Plus may interact with other medications.

The Mexican Ministry of Health has ordered a recall of Reumofan Plus.

For information about integrative therapies with evidence of benefit for pain relief, please visit Natural Standard's Comparative Effectiveness Database.

NEW Adverse Effects Checker

Natural Standard recently launched a new Adverse Effects Checker, a point-of-care resource for healthcare professionals.

Currently, dietary supplements are not approved by the U.S. Food & Drug Administration (FDA) for safety and effectiveness. It is the responsibility of manufacturers and distributors to ensure products are safe before they are marketed to the public. Manufacturers have been required to report all serious product-related adverse effects to the FDA since December of 2007.

This decision-support tool allows clinicians to quickly search for potential causes of reported adverse effects alphabetically or by category. Users can click on specific adverse effects (such as abdominal cramps or hair loss) to see which integrative therapies may have these effects. The checker results are based on evidence from laboratory and animal studies, human case reports and trials, as well as expert opinion and anecdote.

Natural Standard has also added a Case Report button, which allows users to easily submit case reports for integration into Natural Standard monographs and submission to the FDA.

Natural Standard's evidence-based systematic reviews have always featured potential adverse effects of integrative therapies. The new Adverse Effects Checker conveniently compiles this information in one location for easy use.

To try this new tool, please visit Natural Standard's NEW Adverse Effects Checker.

 

Legal Regulations of Dietary Supplements

Natural Standard is offering a series of upcoming complimentary webinars on integrative medicine. Natural Standard offers these impartial webinars as an informational public service. All webinars are recorded and archived at www.naturalstandard.com/webinars.

Kathleen Jodoin, PharmDc presents an overview of the legal regulations of dietary supplements, including descriptions of the Federal Food Drug and Cosmetic Act (FFDCA), Generally Recognized as Safe (GRAS) and Dietary Supplements Health Education Act (DSHEA), with a focus on claim substantiation and product labeling requirements. Complimentary access to the webinar is now available here (Requires Windows Media Player).

The transcript of this webinar is also available as a PDF.