While both traditional, or allopathic, medical schools and osteopathic medical schools provide the same rigorous health education, osteopathic training adds a more holistic, hands-on component involving manipulation of the musculoskeletal system – for instance, the use of stretching and massage to reduce pain or improve mobility.

“These findings offer reassurance to patients by demonstrating that they can expect high-quality care regardless of whether their physicians received their training from allopathic or osteopathic medical schools,” said senior author Dr. Yusuke Tsugawa, associate professor of medicine in the division of general internal medicine and health services research at the David Geffen School of Medicine at UCLA and associate professor of health policy and management at the UCLA Fielding School of Public Health.

The study will be published May 30 in the peer-reviewed Annals of Internal Medicine.

Both types of physicians are licensed to practice medicine in every state. Currently about 90% of practicing physicians hold MD degrees and 10% have DO degrees. But the latter group is rapidly growing due to an increasing number of osteopathic medical schools, with their numbers having swelled by 72% between 2010 and 2020 compared with a 16% increase in MDs during the same period, and their ranks are expected to continue expanding.

In addition, osteopathic physicians are more likely than their MD counterparts to serve patients in rural and underserved areas.

The researchers relied on four data sources: a 20% sample of Medicare fee-for-service beneficiaries, amounting to about 329,500 people aged 65 years and older who were hospitalized between Jan. 1, 2016 and Dec. 31 2019; Medicare Data on Provider Practice and Specialty; a comprehensive physician database assembled by Doximity, and the American Hospital Association’s annual survey on hospital characteristics. Of the patients, 77% were treated by MDs and 23% were treated by DOs.

The researchers found that patient mortality rates were 9.4% among MDs vs. 9.5% among DOs, patient readmission rates were 15.7% vs. 15.6% respectively, healthcare spending was $1004 vs. $1003, and lengths of stay were 4.5 days for both.

The results are similar because both types of medical schools deliver rigorous, standardized medical education and comply with comparable accreditation standards, including four-year curriculums mixing science and clinical rotations, Tsugawa said.

The study does have some limitations, the researchers write, primarily the fact that they focused on elderly Medicare beneficiaries who were hospitalized with medical conditions, so the results may not apply to other population groups. In addition, they limited outcomes to specific measures of care quality and resource use, so these findings may not generalize to other outcomes.

But the findings “should be reassuring for policymakers, medical educators, and patients because they suggest that any differences between allopathic and osteopathic medical schools, either in terms of educational approach or students who enroll, are not associated with differences in quality or costs of care, at least in the inpatient setting,” the researchers write.

Additional study authors are Dr. Atsushi Miyawaki of UCLA and the University of Tokyo; Dr. Anupam Jena of Harvard University, Massachusetts General Hospital and the National Bureau of Economic Research; and Dr. Nate Gross of Doximity.

The study was funded by the National Institutes of Health’s National Institute on Aging (R01AG068633) and the Social Science Research Council.

Make decisions with your doctor that meet your needs.
Discuss risks, benefits, and costs of tests and treatments. Ask about other options and preventive things you can do.
Be sure you are getting the message.
If you have trouble hearing, ask your doctor to face you when talking and to speak louder and more clearly.
Tell the doctor if you feel rushed, worried, or uncomfortable.
You can offer to return for a second visit or follow up by phone or email.
Learn more about communicating with your doctor:
https:/www.nia.nih.gov/health/ doctor-patient-communication.
National Institute on Aging

For the study, Jeanne Mandelblatt, MD, MPH, director of the Institute for Cancer and Aging Research at Georgetown University’s Lombardi Comprehensive Cancer Center in Washington, D.C., and her colleagues examined survey responses from 2,232 adults participating in the Detroit Research on Cancer Survivors (ROCS) Study, a population-based cohort of African American adult cancer survivors who had been diagnosed with breast, colorectal, lung, or prostate cancer within five years. The investigators used what is called a deficit accumulation index to measure aging-related disease and function, and they examined survey responses to questions including ones related to perceived discrimination. Types of discrimination that were assessed included those related to employment, education, renting and buying property, and treatment by police or neighbors. 

“Discrimination can act as a chronic stressor, which can throw the body off balance, resulting in increases in blood pressure, heart rate, metabolism, inflammation, and numerous other factors. These stressors can also increase rates of aging, leading to greater risk of frailty,” said. Mandelblatt, who is also a professor of oncology and medicine at Georgetown University School of Medicine. “We hypothesize that discrimination can lead to an older biological age than a person’s actual chronological age. This is important to understand as there have been virtually no studies of the relationships between discrimination and aging in the setting of cancer survivorship.”

According to a news release from Wiley, the publisher of CANCER, the team found that only 24.4% of participants had deficit accumulation scores indicating no signs of aging-related frailty. Also, survey responses indicated that two-thirds of participants experienced major discrimination in their lives. Survivors with four to seven types of discrimination events had the largest increase in deficits, even after controlling for age; time from diagnosis; cancer type, stage, and therapy; and sociodemographic variables.

“Our results indicate that after considering the effects of traditional factors on poor health—such as income, education, and types of cancer treatment—discrimination was significantly linked to frailty independent of the other variables,” said Ann Schwartz, PhD, co-lead author on the paper and the leader of the Detroit ROCS Study. “Regardless of whether you were rich or poor, if you experienced more discrimination, then you reported greater levels of frailty.” Schwartz is also professor and associate chair of oncology at Wayne State University School of Medicine and deputy center director at Karmanos Cancer Institute in Detroit.

Dietary protein, along with carbohydrates and fats, is what is known as a macronutrient. These are nutrients the body requires in large quantities to maintain health and function. According to the doctors, macronutrients have unique properties that distinguish them from one another, and they are all used by the body as sources of energy.

When it comes to proteins, they are found in every cell in the human body. They are used for cell structure, growth and repair, and they play a central role in numerous metabolic processes. The antibodies that defend the body are made up of proteins, as are the enzymes that carry out virtually every chemical reaction within the cells. Small wonder, then, that proteins are often referred to as the building blocks of life.

Beans and grains are among a wide range of plant-based proteins. But it’s true that many of these proteins are incomplete. Proteins are made up of long chains of molecules called amino acids. In carrying out the countless functions that maintain life, our bodies use 20 different amino acids. These are joined together in varying lengths and combinations to make thousands of different types of proteins, each with a unique job.

Although our body produces some of the amino acids it needs, it can’t make them all. The nine it can’t make are known as essential amino acids, and they must be obtained through diet. They are histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine. Foods such as meat, fish, poultry, eggs and dairy products contain all of the amino acids that the body needs. They are also present in the exact proportions required for optimal health and body functions. That makes them “complete” proteins.

Other than soy, quinoa and buckwheat, which are complete proteins in themselves, most plant-based proteins are either low in certain amino acids or are missing them altogether. That makes them “incomplete” proteins. The good news is that by eating a variety of plant-based proteins, you can provide your body with combinations of amino acids that add up to a complete protein. For instance, beans and rice each lack certain essential amino acids and are thus incomplete proteins. But eaten together, they form a complete protein, because each contributes the amino acids the other is missing.

While this concept of combining plant-based proteins is particularly important for those on a meat-free diet, it applies to all of us. By eating from a wide range of foods, including vegetables, grains, rice, nuts, seeds and legumes, you’ll get the protein your body needs.

Send your questions to askthedoctors@mednet.ucla.edu, or write: Ask the Doctors, c/o UCLA Health Sciences Media Relations, 10960 Wilshire Blvd., Suite 1955, Los Angeles, CA, 90024. Owing to the volume of mail, personal replies cannot be provided.)

COVID-19 Vaccine COVID-19 is a respiratory disease that causes symptoms such as fever, cough, and shortness of breath. Older adults are more likely than younger people to get very sick from COVID-19. The disease can lead to serious illness and death.

Studies show that COVID-19 vaccines reduce the risk of getting this disease. The vaccine will also help keep you from getting seriously ill or having to go to the hospital if you do get COVID-19. We are still learning how effective COVID-19 vaccines are against new variants of the virus. Read more about COVID-19 vaccine effectiveness.

The Centers for Disease Control and Prevention (CDC) recommends that older adults stay up to date with COVID-19 vaccines, including booster shots. Read more about COVID-19 vaccines from the CDC. Contact your local health department or visit vaccines.gov to find out where you can get vaccinated.

Flu is a virus that can cause fever, chills, sore throat, stuffy nose, headache, and muscle aches. Flu is very serious when it gets in your lungs. Older adults are at a higher risk for developing serious complications from the flu, such as pneumonia.

The flu is easy to pass from person to person. The virus also changes over time, which means you can get it again. To ensure flu vaccines remain effective, the vaccine is updated every year.

Everyone age 6 months and older should get an annual flu vaccine, but the protection from a flu vaccine can lessen with time, especially in older adults. Still, you are less likely to become seriously ill or hospitalized with the flu if you get the vaccine. A flu vaccine is especially important if you have a chronic health condition such as heart disease or diabetes.

Ideally, you should get your vaccine by the end of October each year, so you are protected when the flu season starts. It takes at least two weeks for the vaccine to be effective. However, if you have not received your flu vaccine by the end of October, it’s not too late — flu season typically peaks in December or January. As long as the flu virus is spreading, getting vaccinated will help protect you.

There are flu vaccines designed specifically for people age 65 and older. Medicare will pay for the vaccine, and so will private health insurance plans. You can get a flu vaccine at a doctor’s office or local health department, as well as at some grocery stores, drug stores, and pharmacies. The vaccine ingredients are the same wherever you receive it.

Pneumococcal disease is a serious infection that spreads from person to person by air. It often causes pneumonia in the lungs and it can affect other parts of the body. Older adults are at higher risk than younger people of getting very sick or dying from pneumococcal disease.

The CDC recommends that all adults age 65 and older get pneumococcal vaccination. This vaccine will help protect you from getting a serious infection, including pneumonia. There are multiple forms of the pneumococcal vaccine: Talk to a health care provider to find out which is best for you. You can also visit the CDC’s Pneumococcal Vaccination webpage to learn more.

Tetanus, diphtheria, and pertussis are diseases caused by bacteria that can lead to serious illness and death.

Tetanus (sometimes called lockjaw) is caused by bacteria found in soil, dust, and manure. It can enter the body through a deep cut or burn.

Diphtheria is a serious illness that can affect the tonsils, throat, nose, or skin. It can spread from person to person.

Pertussis, also known as whooping cough, causes uncontrollable, violent coughing fits that make it hard to breathe. It can spread from person to person.

Getting vaccinated is the best way to prevent tetanus, diphtheria, and pertussis. Most people get vaccinated as children, but you also need booster shots as you get older to stay protected against these diseases. The CDC recommends that adults get a Tdap (tetanus, diphtheria, and pertussis) or Td (tetanus, diphtheria) booster shot every 10 years. Ask a health care provider when you need your booster shot.

Shingles is caused by the same virus as chickenpox. If you had chickenpox, the virus is still in your body. As you get older, the virus could become active again and cause shingles. Shingles affects the nerves. Common symptoms include burning, shooting pain, tingling, and/or itching, as well as a rash with fluid-filled blisters. Even when the rash disappears, the pain can remain. This is called post-herpetic neuralgia, or PHN.

The shingles vaccine is safe, and it may keep you from getting shingles and PHN. Healthy adults age 50 and older should get vaccinated with the shingles vaccine, Shingrix, which is given in two doses. (Zostavax, an earlier shingles vaccine, is no longer available in the United States.)

You should get a shingles vaccine even if you’ve already had chickenpox or the chickenpox vaccine, or if you don’t remember whether you had chickenpox. You should also get the shingles vaccine if you’ve already had shingles or received Zostavax. However, you should not get a vaccine if you currently have shingles, are sick or have a fever, have a weakened immune system, or have had an allergic reaction to Shingrix. Check with a health care provider if you are not sure what to do.

You can get the shingles vaccine at a doctor’s office and at some pharmacies. Medicare Part D and private health insurance plans may pay some or all of the cost. Check with Medicare or your health plan to find out if it is covered.

Travel vaccines Check with a doctor, a pharmacist, or your local health department about vaccines you need if you’re planning to travel to other countries. The vaccines that are required and recommended are based on your destination, planned activities, and medical history. Sometimes multiple vaccines or doses are needed. It’s best to get them at least four to six weeks before you travel to allow time to build up immunity and get the best protection, particularly from those that may require multiple doses. For more information, visit the CDC website or call its information line at 800-232-4636.

Vaccines are very safe, and they can help keep you from getting serious or life-threatening diseases. The most common side effects for all these vaccines are mild and may include pain, swelling, or redness where the vaccine was given. Before getting any vaccine, talk with a doctor or pharmacist about your health history, including past illnesses and treatments, as well as any allergies. Click here to learn more about vaccine safety and side effects.

A health care provider can address any concerns you have. It’s also a good idea to keep your own vaccination record, listing the types and dates of your shots, along with any side effects or problems.

Not only is this a common disease in certain countries, but it also isn’t life-threatening. It won’t suddenly turn into a pandemic in the manner netizens everywhere are fearing. Let’s absorb everything you need to know about monkeypox so that you can understand why this is an illness people everywhere are restless about.

What is Monkeypox?

One thing is clear: there are substantial differences between monkeypox and the pandemic we are currently experiencing. COVID was unknown and could be considered deadly, especially in 2020. However, monkeypox isn’t deadly and even if it can’t be treated, there are ways to handle the symptoms. It’s a disease that was first unearthed in 1958.

Monkeypox is rare and it’s caused by the monkeypox virus. It starts with flu-like symptoms along with a rash. It is similar to the better-known virus that causes smallpox, and this is why people are so worried about it. Many are still living with COVID and are afraid that another pandemic might strike the world, but it won’t and there are many explanations as to why.

The Discovery of Monkeypox

Monkeypox was discovered previously in 1958. If it was a serious disease, it would have amalgamated into a pandemic when it was first discovered. The disease doesn’t originate from monkeys, contrary to popular belief. At the moment, scientists suspect that the disease derives from small rodents and squirrels in Africa.

There are two strains of the virus. One can be found in Central Africa and the other in West Africa, with the Central African strain being more severe. But rest assured, it doesn’t spread as easily as COVID.

The Spread and Prevention of Monkeypox

The monkeypox virus isn’t spread the same way as the coronavirus behind COVID-19, and this is why you shouldn’t be overly concerned about it. It is only unfurled onto others when you come into contact with an animal or human who is infected. It only gets transmitted through broken skin, blood, bodily fluids, or pox lesions. So, as long as you don’t touch the infected person, you won’t contract the virus. This is why it’s considered a rare occurrence and why it won’t ever become a pandemic.

Prevention is actually easier than the COVID pandemic we are currently living in. You need to avoid contact with infected animals, such as sick or dead ones. You should also avoid contact with any materials used by an infected person, such as clothing, bedding, towels, and anything they might have touched. Washing your hands after coming into contact with animals or infected persons is what you’ll need to keep in mind.

There’s arguably nothing to worry about when it comes to monkeypox, as far as global medical crises are concerned. As shown in this article, this isn’t a newfangled disease, and there is already research in progress to formulate a vaccine. Unlike smallpox, you can only contract the disease by direct contact with an animal infected by the virus or by an infected individual. If you are still living with COVID restrictions and continue to keep social distancing in mind, you won’t have any major issues related to getting infected by monkeypox. It isn’t really a super-pandemic in waiting, and so there’s no cause for pervasive panic.

Naheed Ali, MD, PhD, is a freelance medical journalist at HealthcarePropulsion.com NAHEED ALI, MD, PHDLinkedIn: https://www.linkedin.com/in/medicalandhealthwriter/Medical Writing and CommunicationsAmerican Medical Writers Association

EXPERT’S PROFILE

Naheed Ali is a physician by education and a writer by choice since 2005. He earned an MD degree in 2008 and later completed Harvard Medical School’s lifestyle medicine training in 2012, before obtaining a PhD in holistic health elsewhere in 2013. He brings more than 15 years of experience working in a remote environment and has more than 15 years of health-related publications to his credit.He taught at colleges in the US where he lectured on various biomedical topics and delivered over 2000 hours of live presentations. He is the author of numerous health titles from major publishers and his medical books have sold more than 20,000 hardcover copies worldwide.Now a digital nomad, he’s a freelance health and wellness writer for hire. In his spare time, he enjoys fishing, traveling, and investing in real estate. Visit him at HealthcarePropulsion.com.

Bio:

Naheed Ali, MD, PhD, is a physician by education and a writer by choice since 2005. He earned an MD degree in 2008 and later completed Harvard Medical School’s lifestyle medicine training in 2012, before obtaining a PhD in holistic health elsewhere in 2013. He brings more than 15 years of experience working in a remote environment and has more than 15 years of health-related publications to his credit.

There are two types of dietary fiber, according to a National Institutes of Health (NIH)news release written by Larisa Gearhart-Serna, Ph.D., MBA.

Soluble fibers mix with water and slow digestion. The news release says soluble fibers are associated with a decreased risk of heart disease, decreased cholesterol levels, and better blood sugar control. Soluble fiber can be found in some grains, seeds, legumes, and various vegetables. Insoluble fibers are found in foods such as whole grains, beans, and root vegetables. They act as bulk that can help food and waste pass through the gut more easily. The health effects of different dietary fibers, particularly soluble ones, depend partly on their interactions with the microbes that live in the gut, the gut microbiome.

An NIH-funded team at Stanford School of Medicine led by Dr. Michael Snyder explored the effects of consuming different types of fibers. They enrolled 18 participants—ten women and eight men—and gave them increasing amounts of fiber supplements for three weeks each. The supplements were arabinoxylan (AX), long-chain inulin (LCI), and a mix of five fibers. AX and LCI are popular purified soluble fiber supplements. AX is found in whole grains and other plants, while LCI is found in chicory root and vegetables such as onions and artichokes.

Each participant took each supplement for three weeks, with 6- to 8-week periods in between during which they took no fiber supplements. The researchers took a variety of measurements from blood and stool samples throughout the study. They looked at a range of health markers, including those involved in metabolism and immune function. Participants also kept food logs so that the researchers could monitor their entire diet, including fiber from other sources. Results appeared on April 27, 2022, in Cell Host & Microbe.

The team found that different types of fiber had different effects on markers of human health. For example, for most people AX was associated with reduced cholesterol and increased bile acids, which are made from cholesterol. LCI was associated with increased Bifidobacterium, a beneficial gut bacterium. Both purified forms of dietary fiber had stronger effects than the mix of fibers.

While most of the changes seen were beneficial, high doses of LCI were associated for a few people with increased inflammation and elevated levels of alanine aminotransferase, which can be a sign of liver damage. Furthermore, gut microbial diversity decreased when people were taking the purified fiber supplements.

The effects of the fiber supplements were unique to different people. Some people, for example, did not have reduced cholesterol when ingesting the AX supplement but did when consuming LCI. The results suggest that, while some general trends may be common, the optimum fiber intake for each person may vary. More work is needed to further explore these findings and the mechanisms by which different fibers affect health.

 “Overall, our findings show that the benefits of fiber are dependent on fiber type, dose, and participant—a landscape of factors resulting from interactions between fiber, the gut microbiome, and host,” Snyder said in the NIH news release. “These results have important implications in personalized response and interventions.”

The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.

But not all those products undergo premarket approval — that is, a review of safety, quality, and effectiveness by FDA experts and agency approval before a product can be sold to consumers. In some cases, the FDA’s enforcement efforts focus on products after they are already for sale. That is determined by Congress in establishing the FDA’s authorities. Even when FDA approval is not required before a product is sold, the agency has legal regulatory authority to act when safety issues arise.

Here is a guide to how the FDA regulates products for people — and what the agency does (and doesn’t) approve.

The FDA doesn’t approve facilities.

The FDA does not “approve” health care providers, including physician offices, or laboratories. The FDA does have authority to inspect regulated facilities to verify that they comply with current good manufacturing practices.

Although manufacturing facilities and contract manufacturers are often inspected as part of a product application for certain products that require premarket approval, the agency does not approve manufacturing facilities independently. The FDA does have authority to inspect regulated facilities to verify that they comply with applicable current good manufacturing practices and other requirements, including an adequately designed and controlled production process.

Unless an exemption applies, owners and operators of domestic or foreign food, drug, and most device facilities must register with the FDA before exporting products to the U.S. Owners and operators of establishments that manufacture blood products or cells, tissues, and cellular and tissue-based products must also register with the agency.

Mammography facilities must be FDA-certified and must display their FDA certificates where patients can see them. The certificate indicates that the facilities have met stringent standards for providing quality mammography.

The FDA does not have regulations specific to good manufacturing practices for cosmetics. Cosmetic companies are not required to register their products or facilities with the FDA but may do so voluntarily.

The FDA approves new human drugs and biological products.

New drugs and biological products for people must be FDA approved before they are marketed in interstate commerce. This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards. If the FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.

Some examples of biological products that require approval are therapeutic proteins, vaccines, allergenic products, cellular and gene therapies, and products manufactured from plasma. Manufacturers must also prove that they are able to make the drug or biological product according to federal quality standards.

The FDA does not develop products before approving them. Instead, FDA experts conduct a careful evaluation of the results of laboratory, animal, and human clinical testing done by manufacturers. The FDA does perform lot release testing of many biological products, which provides the agency with a real-time system to continuously monitor product quality, through review and testing.

For more information, see:

A directory of approved and unapproved finished drugs on the market.

A complete list of licensed biological products.

The FDA doesn’t approve compounded drugs.

Compounding is generally a practice in which a pharmacist or a doctor combines ingredients to create medications that meet the needs of individual patients, including those who are allergic to ingredients in FDA-approved medicines or who cannot swallow an FDA-approved pill.

Be aware that compounded drugs are not FDA approved.

This means that the FDA does not conduct premarket review for compounded drugs to evaluate their safety, effectiveness, or quality.

The FDA uses a risk-based, tiered approach for regulating medical devices for people.

The FDA classifies devices according to risk and the level of regulatory controls needed to provide a reasonable assurance of the safety and effectiveness of the devices. The highest-risk devices (Class III), such as mechanical heart valves and implantable infusion pumps, generally require FDA approval of a premarket approval application before marketing. To receive FDA approval for these devices, manufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses.

Generally, the FDA “clears” moderate-risk medical devices (Class II) (for example dialysis equipment and many types of catheters) for marketing once it has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval. Class II devices are generally subject to special controls, which may include specific testing or labeling requirements for that device.

Devices that are low risk of harm to the user (Class I) (for example non-powered breast pumps, elastic bandages, tongue depressors, and exam gloves) are subject to general controls only, and most are exempt from premarket notification requirements.

The FDA uses a risk-based approach for human cells and tissues.

All human cells and tissues intended for use in people — collectively referred to as human cells, tissues, and cellular and tissue-based products (HCT/Ps) — are regulated to prevent the transmission of infectious disease. Examples of HCT/Ps include bone, skin, corneas, ligaments, tendons, dura mater, heart valves, and reproductive tissue.

Those HCT/Ps that pose an additional risk because of their processing or use also require FDA approval before marketing.

The FDA does not regulate the transplantation of vascularized human organ transplants such as kidney, liver, heart, lung, or pancreas. The Health Resources Services Administration (HRSA) oversees the transplantation of vascularized human organs.

The FDA doesn’t approve tobacco products.

There’s no such thing as a safe tobacco product, so the FDA’s safe and effective standard for evaluating medical products does not apply to tobacco products. Instead, the FDA regulates tobacco products based on a public health standard that considers the product’s risks to the population, including users and nonusers of tobacco products.

To legally sell or distribute a new tobacco product in the U.S., manufacturers must receive authorization from the FDA. There are three pathways available to bring a new tobacco product to market: premarket tobacco product applications, substantial equivalence applications, or exemption from substantial equivalence requests.

A marketing authorization does not indicate that the tobacco product is either safe or “approved.” It means that the manufacturer has complied with the requirements under the law to bring its product to market.

The FDA approves food additives in food for people.

Although the FDA does not have premarket approval of food products, it has the authority to approve certain ingredients before they are used in food or intended to contact food. Those include food additives (substances added intentionally to food, as well as substances that migrate to food from food contact products such as food packaging), and color additives.

Companies that want to add new food additives to food are responsible for providing the FDA with information demonstrating that the additives are safe. FDA experts review the results of appropriate tests done by companies to ensure that the food additive is safe for its intended use. An approved food additive must be used in compliance with its approved uses, specifications, and restrictions.

Certain food ingredients, such as those that are considered “generally recognized as safe” (GRAS) for their intended conditions of use by scientific experts, do not require premarket approval by the FDA. The FDA has a voluntary notification process under which a manufacturer may submit a conclusion that the use of an ingredient is GRAS.

The FDA approves color additives used in FDA-regulated products.

This includes those used in food (including animal food), dietary supplements, drugs, cosmetics, and some medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the agency before market entry, and each must be used only in compliance with its approved uses, specifications, and restrictions.

In the approval process, the FDA evaluates safety data to ensure that a color additive is safe for its intended purposes.

The FDA does not approve cosmetics.

Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations. Cosmetic products and ingredients, and their labeling, do not require FDA approval.

There’s one exception: color additives (other than coal-tar hair dyes). Cosmetics must be safe for their intended use and properly labeled.

The FDA doesn’t approve medical foods.

A medical food is formulated to be consumed or administered enterally and intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. An example of a disease or condition that a medical food could be used to manage is phenylketonuria, a genetic disorder. Someone with this disorder may need medical foods that are formulated to be free of the amino acid phenylalanine.

A medical food is intended for use under the supervision of a physician. It doesn’t include products such as meal replacements or diet shakes, or products for the management of diseases, such as diabetes, that can be managed through modification of the normal diet alone.

Medical foods do not undergo premarket approval by the FDA. Still, medical food companies must comply with other requirements, such as current good manufacturing practices and registration of food facilities. Medical foods do not have to include a Nutrition Facts label on their labels; however, any statements on their label or in other labeling must be truthful and not misleading.

The FDA doesn’t approve infant formula.

The FDA does not approve infant formulas before they can be marketed. But manufacturers of infant formula are subject to the FDA’s regulatory oversight. Manufacturers must ensure that their infant formula complies with federal nutrient requirements and other regulations. Manufacturers must register with the FDA and provide the agency with an infant formula submission before marketing a new formula.

The FDA conducts yearly inspections of all facilities that manufacture infant formula and collects and analyzes product samples. The FDA also inspects new facilities. If the FDA determines that an adulterated or misbranded infant formula presents a risk to human health, the manufacturer of the formula must conduct a recall.

The FDA doesn’t approve dietary supplements.

The FDA is not authorized to approve dietary supplements for safety and effectiveness. In fact, many dietary supplements can be marketed without even notifying the FDA.

But companies are required to submit a premarket safety notification to the FDA at least 75 days before marketing dietary supplements containing certain “new dietary ingredients” (that were not marketed in the U.S. before Oct. 15, 1994).

Dietary supplement companies must ensure their products are safe before marketing and comply with other labeling and quality requirements, such as good manufacturing practices.

The FDA inspects facilities for compliance and monitors adverse event reports. When public health concerns arise about the safety of a dietary supplement or an ingredient, the FDA has the authority to take action to protect the public.

The FDA doesn’t approve the food label, including the Nutrition Facts label.

The FDA does not approve individual food labels before food products can be marketed. But FDA regulations require specific labeling elements, including nutrition information, to appear on most foods, including dietary supplements. Also, any statements on food products must be truthful and not misleading – and must comply with any regulatory requirements for the type of statement, as applicable.

Manufacturers must provide the serving size of the food and specified information about the nutrient content of each serving on the “Nutrition Facts” label (or on the “Supplement Facts” label for dietary supplements).

The FDA doesn’t approve structure-function claims on dietary supplements and other foods. Structure-function claims describe the role of a food or food component (such as a nutrient) that is intended to affect the structure or function of the human body. One example is “calcium builds strong bones.”

Dietary supplement companies that make structure-function claims on labels or in other labeling must submit a notification to the FDA. Structure-function claims on dietary supplements carry a disclaimer stating that the claim has not been evaluated by the FDA, and that the product is not intended to diagnose, treat, cure, or prevent any disease.

The FDA does not require conventional food manufacturers to notify the FDA about their structure-function claims or to carry a disclaimer.  By law, all such claims must be truthful and not misleading.

Reprinted courtesy of FDA Health Information

Let’s continue the discussions with advice from authors and experts across a broad spectrum of backgrounds and experience:Surround yourself with people who build you up. This pandemic has been isolating for all of us. We spent less time with friends and family, and many people have been down due to the lack of structure in their lives. Negativity has been rampant. We all can’t afford to spend our time around negative, “glass half empty” people. Limit your time around people who are constantly criticizing you or pointing out why you shouldn’t take a risk. Instead choose to spend time with friends and family who see your strengths and focus on the possibilities that you can achieve.

Volunteer.

One way to add positive people to your life and also improve your mood is through volunteering. Whether it involves helping out at a homeless shelter, delivering food to those in need or volunteering to walk dogs at the local animal shelter your mood will improve along with you contributing to make the world a better place. Often local churches or synagogues have group activities in order to maximize the efforts of participants. Big Brother/Big Sister programs can also use more role models for kids in the community. Volunteering is also a great way to meet people too.—Alyson Nerenberg, Psy. D., licensed psychologist specializing in relationships and addictions and author of No Perfect Love: Shattering the Illusion of Flawless Relationships

Remember that you are more than your mental health diagnosis.

Your diagnosis colors the contours of who you are—adding indigos, teals, burnt oranges, magentas, ambers, crimsons, mauves—to the canvas of your life but it does not define who you are. You are the artist who captures those colors to create a portrait of depth and meaning, filled with the joy, sorrow, talent, weakness, determination, and uncertainty that are you. Pick up your artist’s palette and immerse yourself in your colors. You are more than your mental health diagnosis. You are the artist.—Lyn Barrett, retired teacher and author of Crazy: Reclaiming Life from the Shadow of Traumatic Memory

Don’t be afraid to talk to someone.

Some people think that seeking help for mental health issues shows weakness. In fact, the opposite is true. All of us face difficult issues: job loss, quarrels with friends, the death of family members, etc. Pretending that these crises do not upset us prevents individuals from making progress. Therapists can help us to understand ourselves better and to see patterns in our reactions to difficult situations. Trained counselors give us insights and advice that enables us to draw on our strengths and move more calmly through life.—Janet Ruth Heller, retired college professor and author of Nature’s Olympics

Know who you aren’t.

Often, our fatigue comes from spending so much time with the weight of the world squarely on our shoulders. If you’re an empathetic human being, it can be tempting to feel obligated to change and fix every situation you become aware of, to saddle yourself with unrealistic expectations that you can’t and aren’t required to meet. Yes, you are a once-in-history creation with an unprecedented arrangement of gifts that no one else has ever had or will have. But you’re not invincible and you’re not unlimited in your physical and emotional resources. Learn when to put down the superhero costume and be mortal for a while. Have the wisdom and humility to do what you can and know when to rest in what you can’t.

Share the load.

One of the greatest sources of exhaustion, is the feeling that we are alone here: that no one else cares about what we care about or is fighting for what we’re fighting for. This is almost never true, but the more time we spend by ourselves, the easier it is to believe that. Community is medicinal. When we share our life and work with like-hearted people in meaningful, interdependent relationships, we are far less likely to burn out quickly, which is the goal. This isn’t about you expiring early, it’s about a lifestyle of sustainable compassion that will allow you not only to care deeply, but to be here a long time while you do. Finding your tribe will make this far easier. Don’t go it alone.—John Pavlovitz, pastor and author of If God is Love, Don’t be a Jerk

“Read” Pictures.

Reading is a great tool for learning about emotions, and picture books offer an additional tool for teaching emotional literacy: illustrations. When a happy, scary, or frustrating event occurs in a story, pause and look at the picture together. Ask, “Look at them—how do you think they are feeling right now?” Examine characters’ facial expressions, body language, and what they are doing. You can use this same technique when you watch movies, shows, or videos together. These strategies work best when we, as adults, model them. Children take their emotional cues from us, so talk about how you are feeling and why. Share what you do to feel better and calm down when you are sad, mad, or scared. Practice mindfulness with children. And curl up and read a good book together—an activity that is sure to help children feel safe and loved!—Deborah Farmer Kris, child development specialist and author of the All the Time children’s picture book series

Exercise is essential to managing both acute and generalized anxiety.

Although I play sports both in and outside of school, that’s not where my level of activity stops. Your physical activity doesn’t have to be anything competitive. If you like yoga classes or playing tennis at the local rec center, that’s great. By taking part in any kind of aerobic activity, you are not only helping your body to release stressful toxins but you are also focusing on something other than your anxiety. Anything that gets you moving and your blood flowing will be helpful. Exercise reduces your level of stress hormones and stimulates the production of endorphins, hormones that are known to elevate your mood.—Carter Weinstein, college student and author of Conquering Fear: One Teen’s Guide to Overcoming Anxiety

Therapy can’t help sociopaths, but it is crucial for their targets.

The prevailing view in the mental health field is that sociopaths “burn out” and engage in less antisocial behavior as they age. It’s not true. For my book, survey respondents described people whom they believed were senior sociopaths. Of the respondents who knew the individuals both before and after age 50, 91% said their behavior was just as bad, or worse, as they aged. Survivors often feel like they are to blame for what they endured, when the truth is that they were manipulated and deceived.—Donna Andersen, dysfunctional relationships expert and author of Senior Sociopaths: How to Recognize and Escape Lifelong Abusers

Let yourself off the hook.

Try mindfulness in tiny bursts, and realize that you are going to “fail” at it every time. There is no “right” way to practice mindfulness. The job is to bring your awareness back to the present moment. Some days that means pretending I’m a Buddhist monk while I sit on my deck filled with warm sunshine. That is, until the circus monkeys start banging their drums and I’m off into my very not-present-moment thoughts. Even the tiniest respite from our shared insanity is the possibility of a sliver of contentment. Use grounding techniques. Above all, remember that the moment won’t always feel good, but it won’t always feel bad either. Be kind to yourself when you practice any new skill. Just kindness turned inward can radically change your life. One tiny moment at a time.—Caitlin Billings, psychotherapist, licensed clinical social worker and author of In Our Blood (July 2022)

Mental Health Awareness Month is the perfect time to seek help or advice without feeling shame.

Consider these tips for taking care of yourself, and find the best ways to manage and improve your stress levels, coping mechanisms, and support systems that you can use all year long.

What is hospice?

According to the National Institute on Aging, a division of the U.S. Department of Health & Human Services, “Hospice care focuses on the care, comfort and quality of life of a person who is approaching the end-of-life[i].”

In order to qualify for hospice, a patient needs to meet certain criteria to gain hospice benefits under insurance.  People can be designated as being at end-of-life if they have advanced, incurable illnesses or conditions that make them exceptionally high risk. They could also have experienced sudden, life-threatening conditions like strokes or accidents from which they are not expected to recover. Consequently, end-of-life care can take place over a matter of days, weeks, or months. The goal of hospice is to treat patients with terminal illness having a six-months or less prognosis for life.

Hospice care is specialized care involving an interdisciplinary team of professionals focused on patients and families. The hospice team addresses symptom management, communication and decision-making, and coordination of care services.  Hospice has a regulated, well-planned payment and care system. The types of clinicians are specified and must hit certain milestones; hospice also outlines the frequency of meetings for the patient with the care team and identifies particular levels of care and last days of life care.

How does non-hospice palliative care differ from hospice?

Palliative care can occur at any point in a person’s illness, not just end-of-life. Fighting a long or severe, acute illness may cause emotional or mental trauma. Aggressive treatment of an illness may exacerbate this trauma, and it may go untreated while healthcare professionals are treating the primary illness. It is crucial to care for the patient’s emotional well-being while still treating the primary illness.

Palliative care is often referred to as “comfort care” because it is a holistic healthcare approach to keep the patient as comfortable as possible. Palliative care teams, like hospice teams, may include specialized doctors, nurses, social workers, nutritionists, and chaplains, who treat the trauma while treating the primary illness.

However, the insurance support of palliative care is typically less than that of hospice, depending on the particular illness being treated and the types of therapy being used, which could range from chemotherapy to surgery, or other types of curative treatment. The frequency is also less than with hospice and may be once a month or once a week to support symptom management – but is not dependent on it being end of life.

How do these types of care work?

When patients enter hospice, they designate a primary caregiver—often a family member or close friend—to help them through their hospice journey. The primary caregiver works with the patient’s hospice care team throughout the process[ii].  The hospice team provides medical care that will help someone in end-of-life stages live with the best quality of life as possible.

Palliative care, on the other hand, can begin during an initial diagnosis, and is flexible. Healthcare professionals can provide palliative care wherever patients require treatment—hospital, outpatient clinics, home. Patients can receive palliative care regardless of diagnosis type and duration, at any point in treatment, if ordered by their primary physician. Different types of healthcare professionals administer palliative care during other treatments.

How does non-hospice palliative care help?

Palliative care, not through the hospice benefit, can be concurrent with aggressive treatment focused on acute or chronic illness. Palliative care addresses alleviation of pain and anxiety, in other words, symptom management during curative care. Curative care seeks to promote recovery; non-hospice palliative care helps provide comfort from serious illnesses that may not be life-threatening.

In addition to helping relieve pain, palliative care creates an open dialogue among patients, families, and caregivers, building a deeper understanding of illnesses and treatments. This process helps patients and families work through complex emotions and choose treatments best for them.

Frank conversations at the non-hospice care stage are extremely helpful if a transition to hospice becomes necessary. Families and patients already familiar with palliative care are more prepared to assess whether quality of life care is more crucial than daily care to smooth the transition to hospice.

When is hospice called in?

The goal of hospice is to help meet a patient’s holistic needs—physical, mental, spiritual—when curative efforts are no longer warranted by the illness nor desired by the patient.

Hospice care is only available for patients who are terminally ill, having six months or less to live. Patients must receive certification from their doctors and designated hospice doctors, and sign statements indicating their choice of hospice care over other insurance-approved efforts to treat terminal illnesses and related conditions.

Patients can continue to receive Medicare-certified hospice care beyond six months, provided their doctors (regular and hospice) re-certify them. Patients in hospice can also choose to transition to curative or palliative care at any time if their case becomes more hopeful.

Both hospice and non-hospice palliative care can be especially vital for patients in serious illness and end-of-life stages.

Jose Luis Escobar is Vice President and Executive Director of Parentis Health Hospice, where he shepherds patients and families through a complex process with compassion and genuine care for everyone, providing compassionate and genuine care for everyone, providing knowledge and comfort through every stage of life’s journey.