Health

FDA’s Head Wants New Regulation For Kratom And CBD

The head of the food and drug administration says its agency required Congress’s new authority to regulate kratom and CBD’s natural substances. Many Americans use these two natural substances to treat their pain and different medical conditions.

On Thursday, 19 May 2022, FDA Commissioner Dr. Robert Califf testified in front of a House Appropriations subcommittee. The subcommittee asked why the agency was slow in making new CBD regulations and why the FDA remains opposed to the use of kratom products. The head of the FDA said his agency needs new regulation pathways for kratom and CBD because both the products fall between the cracks of existing law and gives the broad authority to regulate food and drug to the FDA.

The U.S senate recently confirmed Cliff as FDA commissioner, and he has done this job since Obama was a president. He noticed a little bit of progress by the FDA in regulating CBD and cannabis products since he left.

He said, “ You know when you come six years later to the job you had before and nothing has really changed, that’s telling you that you can’t just keep trying to do the same thing over and over,”

FDA Concerns Regarding Kratom And CBD

The u.s food and drug administration warns consumers to avoid mitragyna speciosa, called kratom. It’s a plant that grows naturally in South Asia, including Thailand, Malaysia, Indonesia, and Papua New Guinea. At the same time, the FDA has recognized the potential use of cannabis products or CBD. But the FDA said some companies in the market violate the Federal Food, Drug and Cosmetic Act (FD&C Act), and they may put the consumer’s health at risk, which is why the FDA needs to regulate cannabis more efficiently.

FDA has not approved the kratom because the agency has reported concerns about its safety. FDA is actively evaluating all the available concern cases. The FDA is also concerned that kratom has the same binding property as opioids, which may lead to addiction and dependence.

CBD regulating difficulties come due to the legalization of hemp under federal law 2018 farm bill. Because at that time, believed that hemp had no or least psychoactive property and had no harmful effect. But after the PNN reported, some cannabis companies concentrated delta-8 tetrahydrocannabinol (delta-8 THC) derived from hemp and used it in edibles that give consumers a mildly intoxicating effect.

The FDA’s Head Suggests Congress Do More For Both Products

FDA Commissioner Dr. Robert M. Califf said to the House Appropriations subcommittee, “It looks pretty much the same in terms of where we are now,”

During the hearing, he told the committee, “We just know more because we’ve done more research.” for both the regulation of CBD and therapeutic use of the Kratom.

The FDA has spent lots of funds on cannabidiol to determine its use in other things and its risk. cliff also adds that

“The amazing plethora of derivatives of the cannabis plant [are] surely quite profound and astounding and already in widespread use for a variety of means.”

Now Cliff wants the FDA to move forwards, and his agency needs more regulatory power from congress to move ahead.

Cliff said the current authorities do not give us the necessary power to go on the right pathway. The FDA head said, “We’re going to have to come up with something new. I’m very committed to doing that.”

FDA’s Position On Kratom “Extremely Antiquated

In the new updated online fact sheet, the FDA agency mentioned kratom’s effects on the brain. The agency said that kratom has the properties that may cause addiction, abuse, and dependence.

Rep. Mark Pocan (D-WI), who supports the kratom legality effort, said that the FDA’s position on kratom “is extremely antiquated.”

Pocan told the FDA’s head, “Honestly, there are not only arguable conclusions (in the update), but you are linking to outdated, incomplete, and inaccurate information.“ he said That update was not much of an update, and I think it’s being very unfair to the consumers who are legally consuming kratom in this country,”

Now kratom is banned in many states. The worldwide banning efforts of Kratom in 2016 have failed because of the public outcry. The inadequate evidence and lack of data failed the request to schedule Kratom by the FDA.

Jonathan Miller, Remarks On FDA’s Head Statement

Jonathan Miller, the general council for the U.S and Hemp Roundtable of an industry group, said to Marijuana Moment in a statement that he likes Cliff’s responses on the 19 may 2022 hearing.

“I’m quite encouraged by the tone of Commissioner Califf’s remarks—his frustration that nothing has been accomplished by the agency in the six years since he last served in that position, as well as his repeated commitment to identify pathways for CBD,”

Miller also said he is looking for a creative approach and the U.S. Hemp Roundtable also wants to work with the FDA on this research.

CONCLUSION

Millions of Americans use kratom and CBD. The user wants the FDA and Congress to take steps to correct the issues of adding other contamination. The main concern is that the companies add other harmful substances and mislabel the kratom and CBD products, making both products toxic compounds. While the user always supports both the products and says they are helpful in the treatment of many medical conditions like pain, anxiety, depression, and mood enhancement.

Now the FDA congress has decided to work and support each other to find the right path for regulating kratom and CBD. and perform more research that will be helpful to make the right decision.

Cliff said He would continue to work with the National Institute on Drug Abuse (NIDA) for kratom products. Still, for cannabis, we need some different pathways because cannabis is not a traditional food nor a drug. So we need to do something to regulate them.

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Health

Report Causes Pfizer Stock to Climb Approximately $1 Billion Acquired by Starboard

(VOR News) – According to a rumor that activist investor Pfizer Starboard Value has taken a holding in the struggling pharmaceutical business that is expected to be worth around one billion dollars, the stock of Pfizer (PFE) is on the increase in premarket trading on Monday.

This comes after the report was made public. The report was made available to the general public following this. Starboard Value was successful in moving forward with the acquisition of the position.

Starboard is said to have approached Ian Read, a former chief executive officer of Pfizer, and Frank D’Amelio, a former chief financial officer, in order to seek assistance with its goals of boosting the performance of the company, according to the Wall Street Journal. Read and D’Amelio are both former Pfizer executives.

The purpose of this is to facilitate the accomplishment of its objectives, which include enhancing the overall performance of the firm.

In their previous jobs, D’Amelio and Read were chief financial officers.

It is stated in the report that the hedge fund is of the opinion that Pfizer, which is currently being managed by Albert Bourla, who succeeded Read as Chief Executive Officer (CEO) in 2019, does not demonstrate the same level of mergers and acquisitions (M&A) discipline that Read did. Bourla took over for Read in 2019. Read was succeeded by Bourla in the year 2019.

Pfizer, a multinational pharmaceutical conglomerate, has made substantial investments in the acquisition of more companies that are involved in the research and development of cancer medicines.

These businesses have been acquired for billions of dollars. The biotechnology company Seagen, which was acquired by Pfizer in the previous year for a price of $43 billion, is included in this category. One of the businesses that can be classified as belonging to this category is Seagen.

In spite of the fact that the S&P 500 Index experienced a 21% increase in 2024.

No major trading occurred in Pfizer stock that year.

Due to the fact that the demand for Pfizer’s COVID-19 vaccines fell after the firm reached its pandemic peak in 2021, the share price of the corporation has decreased by over fifty percent since that time.

This drop has occurred ever since the company’s shares reached their maximum peak, which was during the time that this decline occurred. Not only have they not changed at all, but they have also remained essentially stable. This is in contrast to the S&P 500, which has gained 21% since the beginning of this year.

Recently, the corporation was forced to take a hit when it decided to recall all of the sickle cell illness medications that it had distributed all over the world.

Fears that the prescription could lead patients to experience severe agony and possibly even death were the impetus for the decision to recall the product. In spite of the fact that Pfizer’s stock is increasing by almost three percent as a result of the news that followed the company’s decision, this is the circumstance that has come about.

SOURCE: IPN

Health

New Study Reveals Drinking Soda Pop Increases the Risk of Stroke

If you drink too much soda, fruit juice and coffee, beware!

A recent report from global research indicates that excessive consumption of coffee or soda pop is associated with an increased risk of stroke, although the intake of black and green tea is correlated with a reduced risk. Excessive consumption of soda pop or coffee warrants caution!

Recent research indicates that it may substantially elevate the risk of stroke.

Consuming four cups of coffee daily elevates the risk of stroke, according to studies, although ingesting 3-4 cups of black or green tea daily typically offers protection against stroke. Additionally, consume more coffee; it may reduce your risk of mortality.

Recent findings from global research studies co-led by the University of Galway and McMaster University, alongside an international consortium of stroke researchers, indicate that soda, encompassing both sugar-sweetened and artificially sweetened variants such as diet or zero sugar, is associated with a 22 percent heightened risk of stroke. The risk escalated significantly with the consumption of two or more of these beverages daily.

Stroke Risk Fizzy Drinks and Soda Pop

The correlation between fizzy drinks consumption and stroke risk was most pronounced in Europe, the Middle East, Africa, and South America. Women exhibit the most elevated risk of stroke from bleeding (intracranial hemorrhage) associated with fruit juice beverages. Consuming over 7 cups of water daily diminishes the likelihood of stroke due to a clot.

Researchers observed that numerous items advertised as fruit juice are derived from concentrates and have added sugars and preservatives, potentially negating the advantages often associated with fresh fruit and instead elevating stroke risk.

Fruit juice beverages were associated with a 37 percent heightened risk of stroke resulting from bleeding (intracranial hemorrhage). Consuming two of these beverages daily increases the risk thrice.

Consuming over four cups of coffee daily elevates the risk of stroke by 37 percent, although lower consumption levels do not correlate with stroke risk. Conversely, tea consumption was associated with an 18-20 percent reduction in stroke risk. Additionally, consuming 3-4 cups daily of black tea, such as Breakfast and Earl Grey varieties, excluding green and herbal teas, was associated with a 29 percent reduced risk of stroke.

Consuming 3-4 cups of green tea daily was associated with a 27 percent reduction in stroke risk. Notably, the addition of milk may diminish or inhibit the advantageous effects of antioxidants present in tea. The lower risk of stroke associated with tea consumption was negated for individuals who added milk.

Disclaimer: This article is intended solely for informational reasons and should not be considered a replacement for professional medical counsel. Consistently consult your physician regarding any inquiries pertaining to a medical problem.

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Starbucks Faces Sales Decline Amid Price Fatigue and Rising Competition

Health

Following a Diagnosis of Breast Cancer, What Else Should You Know?

(VOR News) – Even though breast cancer affects one in eight American women, receiving a diagnosis can make a woman feel isolated.

Experts in breast cancer from the American College of Physicians (ACS) advise patients on how to manage their disease so that they may better cope with this awful information.

First, the kind and stage of breast cancer dictates the course of your care.

In addition to immunotherapy and chemotherapy, there are various surgical options available for the treatment of breast cancer.

Women of African descent are disproportionately affected by triple-negative breast cancer, an extremely aggressive form of the disease that has never proven easy to treat.

According to the American Cancer Society, pembrolizumab (Keytruda), an immunotherapy, has been shown to be helpful when combined with chemotherapy and is currently the recommended course of treatment for certain combinations of triple-negative breast cancer.

In her presentation, Dr. Katharine Yao said, “It’s really important that the patient and physician discuss the patient’s preferences and values when deciding what type of treatment to pursue and that they have an honest, individualized discussion with their care team.”

She is currently responsible for developing breast cancer treatment recommendations for more than 575 hospitals and institutions nationwide in her role as chair of the American College of Surgeons’ National Accreditation Program for Breast Institutions (NAPBC).

Yao, vice chair of research at Endeavor Health NorthShore Hospitals in New York, pointed out that each decision made about a patient’s treatment plan should take her preferences and diagnosis into consideration.

She ought to think about whether she would prefer a mastectomy—a surgical procedure that involves removing the entire breast with or without reconstruction—or a lumpectomy, which involves a surgical procedure that spares part of the breast tissue.

She stated that “the breast cancer you have may be very different from the breast cancer you hear about in your neighbor, colleague, or friend” in a press release issued by the American Cancer Society (ACS).

“Consider that while discussing breast cancer with others.”

Throughout your journey, it is critical that you look after your emotional health because having breast cancer may have a detrimental impact on your mental health.

“Getting a cancer diagnosis does not mean that everything in your life stops to be normal.” Director of the Fellowship in the Diseases of the Breast program at the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas and state head of the American Cancer Society Commission on Cancer for Arkansas, Dr. Daniela Ochoa She thinks adding the burden of a cancer diagnosis and treatment to all the other pressures in life may be taxing.

“Managing stress and emotional health is vital component of a treatment plan.”

Ochoa recommends clinically trained psychologists and social workers who have assisted people in coping with cancer to anyone receiving treatment. Learning coping techniques might also be facilitated by joining cancer support groups or cancer wellness initiatives.

Breast cancer specialists say your care team is crucial.

The American Cancer Society (ACS) defines comprehensive care as having support at every stage of the procedure from surgeons, oncologists, patient navigators, nurses, social workers, psychologists, and other specialists.

After receiving a breast cancer diagnosis, women should see a surgeon or medical oncologist to explore their options; nevertheless, treatment shouldn’t be discontinued after just one appointment or after surgery is over.

Additionally, you can ask trustworthy friends or family members to accompany you to appointments and aid you with research or notes. They could serve as a network of support for you.

Yao stated in his talk that “one of the most important things is that patients should search out a team they have confidence in, that they trust will have their back when they need it, and a team they feel they can get access to and that will help them when they are in need.”

SOURCE: MP