Thursday, May 26, 2022

This Company Uses Oregon Weed to Create Products for Womb Health – Portland Monthly

Can cannabis help your period? What about the effects of menopause? The founders of Xula—a company founded in Mexico and growing all its base products at farms in Southern Oregon’s Applegate Valley—think so. Centered around womb health, Xula creates products tailored to keeping period pain at bay (amen), using cannabinoid combinations and a hearty dose of herbs to pinpoint and treat. 

“For cramps, we have specific herbs like mugwort that have antispasmodic action; for hot flashes, we have specific herbs like black cohosh that help with cooling,” cofounder Karina Primelles says. There’s research behind Xula’s claims: the National Center for Complementary and Integrative Health, the federal agency tasked with researching alternative health approaches, confirms these herbs can help with menstrual cramps and menopause, though thus far the FDA has approved only prescription cannabis drug products. 

Waiting for the FDA seal hasn’t stopped Primelles and cofounder Mennlay Golokeh
Aggrey from launching their brand, however, though it did mean they had to reach for their thinking caps when it came to naming their products. “A lot of that is in response to compliance laws that we had to work with,” Aggrey explains of terms like Moon-a-pause and Lights Out. “We can’t say menopause, we can’t
say PMS. These things, according to the FDA, are considered medical claims.” 

Clever puns notwithstanding, the Xula team takes its formulas seriously, drawing inspiration from both Chinese medicine and Western herbalism.

Aggrey and Primelles introduced the brand in Portland in person in late 2020. Local stores—including CBDlish and Beam & Anchor—got on board, stocking up on Xula tinctures. Wanna do the same? Behold some of its best sellers. 

zzz! lights out
Trouble sleeping? This mixture of full-spectrum CBD (which contains THC), and CBN—a cannabinol known for having sedative effects—works with passionflower and other herbs like kava root and catnip to help get the rest you need, sans sheep. Instructions say to take a drop 30 minutes before bedtime. 





uff! moon + womb
These drops combine CBD with sundry herbs including ginger root, lemon verbena, and black cohosh. The mix is designed to tackle one of the most common gynecological issues: period cramps. Xula recommends pairing this tincture with its topical “Touch and Soothe” body salve. 






ah! calm + clarity
As Xula’s strongest formula, just one drop of Ah! offers an ultra-relaxed vibe, without sleepiness. (We know; we’ve tried it.) The blend of hemp, MCT oil, and herbs including blue vervain is finished with spearmint oil, combining an earthy taste with a delightfully refreshing finish. 

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Food lawyer espouses virtues of dietary supplement product listing – Natural Products INSIDER

In June 2018, during an industry conference in Manhattan, food and drug lawyer Scott Bass made a pitch that drew a strong rebuke, according to his recollection. The dietary supplement industry, Bass asserted at the time in a PowerPoint presentation, must “embrace mandatory product registration.”

“And everybody said, ‘What, are you out of your mind?’” Bass recalled in an interview. “And I said, ‘No,’ because we now have a $50 billion industry I want to see go to $100 billion, and the only way we’re going to do that is to assure governments and the public that we have products that are being looked after.”

Today, as members of Congress continue to hammer out the details of a legislative package reauthorizing FDA’s user-fee agreements for such commodities as prescription drugs and medical devices, Bass’s proposal is closer than ever to becoming embedded in U.S. law. A user-fee authorization bill in the U.S. Senate, the FDA Safety and Landmark Advancements (FDASLA) Act, includes a requirement for mandatory listing of dietary supplement products with FDA.

Mandatory product listing (MPL) has garnered the support of multiple trade associations, FDA and outside groups, including The Pew Charitable Trusts and American Medical Association (AMA). One of its strongest proponents is Sen. Majority Whip Dick Durbin, D-Ill., who introduced a standalone bill in April called the Dietary Supplement Listing Act of 2022.

A subsequent version of MPL in the FDASLA Act incorporates requirements proposed by Durbin, as well as other provisions that would affect dietary supplements.

Reflecting on his remarks in 2018 that he said still hold true today, Bass said, “Why would any responsible company not want the government to know what it’s selling? It just strikes me as so odd.”

MPL has become a divisive issue in the industry, perhaps highlighting philosophical differences over the best ways to evolve the law in an age of smartphones and social media while supporting the twin pillars of the Dietary Supplement Health and Education Act of 1994 (DSHEA): giving FDA authority to adequately protect the public from potentially harmful products while preserving open access to natural products consumed by the majority of Americans.

FDA cannot effectively regulate what it cannot see, and there is no centralized database today containing all the dietary supplement products in the U.S. market, MPL proponents say.

“I think the conversation … the different parts of the industry are having really turns on whether you think transparency is good because it builds confidence in the industry,” said Stuart Pape, a lawyer in Washington, D.C., who advises clients on FDA regulations and previously worked in the agency’s Office of Chief Counsel.

On one hand, proponents of Durbin’s bill believe MPL “facilitates appropriate regulatory intervention and scrutiny,” Pape said in an interview in April after the Dietary Supplement Listing Act was introduced in the Senate. “If you think that’s not a good thing, then the bill is terrible.”

Opponents of MPL have argued “bad actors” or firms already in violation of the law selling, for example, undeclared pharmaceutical ingredients won’t list their “dietary supplement” products with FDA. Some counterarguments are MPL legislation in the Senate would render such products “misbranded” for failure to list and more clearly distinguish—for the benefit of regulators, consumers and retailers—compliant products from non-compliant ones.

Pape said he agrees firms selling products with affirmative knowledge that they contain unlawful ingredients are unlikely to list them with FDA.

But, “So what?” he continued. “There are people who don’t file tax returns. Is that an argument that you shouldn’t be required to file a tax return? We have a tendency to overstate what something might do and then a critic comes along and says, ‘Well, it’s not possibly going to do all the things you claim it’s going to do. Therefore, it’s a bad idea.’ I think that’s part of what’s going on here.”

Asked whether he agreed MPL would let FDA know when new dietary supplement products are introduced to the market, Pape responded, “Mostly true most of the time, not necessarily all of the time.”

Pape also addressed criticism by MPL cynics that FDA under Durbin’s proposal would have discretion to reject products, which essentially amounts to a regulatory regime that cannot be reconciled with DSHEA: premarket approval.

“I think that’s a red herring of world-record size,” he said.

Pape, who serves as chair of the FDA practice at Polsinelli PC and whose law practice has involved such varied commodities as dietary supplements, medical devices and pharmaceuticals, described a listing requirement as “ministerial.”

“You’re required to list. You submit the listing information. You’re listed,” he said.

Pape was interviewed before the Senate released a discussion draft of the FDASLA Act, which includes a provision that would make it a “new prohibited act” to introduce into interstate commerce “any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under Section 201(ff)” of the Federal Food, Drug & Cosmetic Act (FDCA). Durbin’s standalone bill did not include the language above.

The language “clarifies what’s driving these provisions goes well beyond the desire for transparency, a collection of labels or mandatory product listing (MPL),” according to a recent column authored by Natural Products Association (NPA) President and CEO Dan Fabricant. “Instead, it seems driven by a desire to allow FDA to ‘bar the door’ from listing anything it wishes to keep out of dietary supplements….”

Fabricant, who oversaw FDA’s Division of Dietary Supplement Programs from 2011 to 2014, warned the “prohibited act” language is not related to MPL and would give FDA an opportunity to reject ingredients like CBD administratively. Dietary supplement firms found to have committed such a prohibited act also would face potential criminal prosecution from the U.S. Department of Justice for running afoul of the FDCA, which carries civil and criminal penalties.

The “prohibited act” language “could encompass differences of opinion with FDA that shouldn’t rise to a criminal offense,” according to Bass, who is a founder of his law firm’s Global Life Sciences and Food and Drug Law practices in China, Europe and the U.S. “The intent of this section, which is to catch tainted products, [is] overbroad and using a shotgun for something that needs a rifle.”

The language, Bass explained, reflects FDA’s position that its authority isn’t explicit enough under the FDCA to target for enforcement products marketed as dietary supplements yet spiked with undeclared pharmaceutical ingredients.

“What’s really significant here is that [the provision] can apply to any technical argument about whether something’s a supplement or not,” cautioned the lawyer.

Bass believes the provision “can” and must be “fixed.” However, as far as MPL is concerned, he described a listing requirement as “a sine qua non of dietary supplement enforcement and of the future of the dietary supplement industry.”

“Without mandatory listing, there would be no credibility,” he said. “Responsible industry has to welcome mandatory listing.”

The legislation in the Senate, he added, can be tweaked “so that it doesn’t ever become akin to prior approval or to a registration system as opposed to a listing system.”

In an interview three years ago with Natural Products Insider, the late Sen. Orrin Hatch (R-Utah) was asked about a mandatory product listing or registry for dietary supplement products. He was one of the chief architects and champions of DSHEA during his long tenure in the Senate.

“The concept makes sense to me,” Hatch responded. “If this industry wants to be regarded as the mainstream regulated industry that it is, it seems logical that the FDA be able to know what products are out there as they do with other regulated products.”

Hatch warned, “If Congress is to consider a new requirement, that requirement has to be fair and not overly regulatory with too much reporting of information that FDA does not have the resources to use.”

He concluded, “In other words, we should not regulate the dietary supplement industry into the ground, which some people will try to do acting like they’re the sole protectors of our health and strength in this country.”

MPL, some industry critics maintain, is simply a path to imposing additional burdens on responsible industry. Bass, who was one of the industry lawyers who helped to negotiate DSHEA nearly 30 years ago, has been down this road before.

In the recent interview, he recalled strong opposition to a proposal several years ago that manufacturers of dietary supplements report to FDA serious adverse events associated with their products. The Dietary Supplement and Nonprescription Drug Consumer Protection Act was signed into law by President George W. Bush in late 2006 and took effect a year later.

“It’s just been a responsible law that has not killed innovation or killed the industry,” Bass said.

He described opposition from industry as “huge” before the bill was enacted by Congress and signed into law by Bush.

“I’ll never forget that [Sen.] Hatch’s office set up a conference call, and without mentioning the company, a very smart general counsel at one of the companies in Utah got on and hit me in front of 30 people on the phone with … 25 very intelligent objections,” he reflected. “I even had dinner at one point with some of them in Washington. They [said], ‘Oh, this is the end and this is giving FDA all the regulation. We’re going to become food additives.’ None of that happened.”

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Keto Depression: How the Ketogenic Diet Affects Mental Health – Greatist

“Going keto” seems to get trendier each year, but the low carb, high fat life isn’t without its controversies. For instance, some say ketosis can trigger depression. Others claim the ketogenic diet boosts mental health.

So, is keto depression a thing? How does swapping carbs for fat actually affect mental health?

Let’s dig into the research on keto and depression. 🤓

Short answer? If anything, keto might help alleviate rather than cause depression.

A few things to know:

More research is needed to fully understand the link between keto and depression.

It seems like keto diets might help manage depression symptoms. But there are also anecdotal reports of keto depression — basically, feeling low while on the ketogenic diet.

It’s no secret that what you eat can influence everything from hormones to mood. Research indicates that eating keto can relieve epilepsy symptoms, but studies on other benefits for the brain are ongoing.

Here’s what we know so far about how keto affects mental health.

Increases GABA production

Gamma-aminobutyric acid (GABA) is a neurotransmitter (a brain-messaging chemical) that affects how your brain experiences stress and anxiety.

A 2011 research review suggests that low GABA levels can cause or worsen depression. More recently, a small 2020 study indicated that stimulating GABA production might relieve depression symptoms.

So, what stimulates GABA production? Yoga, apparently. But also ketosis.

Scientists are actively investigating whether a ketogenic diet could help the 30 percent of folks with major depressive disorder whose condition is resistant to drug-based therapies. Kinda cool, right?

Might improve mitochondrial functions

“Mitochondria is the powerhouse of the cell.” — every high school biology teacher ever

As you can imagine, your cells’ power source is kinda important. Mitochondrial dysfunction has been linked to many health probs, including depression.

But a keto diet seems to have a positive impact on folks with mitochondrial diseases. And if the keto diet turns out to be effective against mitochondrial dysfunction, the diet might also improve depression caused by the dysfunction.

More research is needed, but it’s a start!

Might decrease oxidative stress

Oxidative stress has been linked to a heap of problems, including depression. (Eat more antioxidants, kids!)

There’s some evidence that a keto diet can reverse damage from oxidative stress. In theory, this might also relieve some symptoms of depression. But a lot more research is needed to learn more about this.

Might regulate insulin

You probably know insulin as the blood sugar patrol, but it can mess with your mood too. And keto might help keep your levels in the safe zone.

Insulin resistance plays a role in the development of major depression, especially in folks living with type 2 diabetes.

There’s growing evidence that keto’s restriction of sugar and starch could help address insulin resistance. Of course, we need more research to say that keto’s effect on insulin can improve depressive symptoms — but there’s a promising link.

Might reduce inflammation

Chronic inflammation is associated with several health probs, including depression.

Inflammation might also increase your risk of insulin resistance, oxidative stress, and mitochondrial dysfunction. It even has a negative effect on the production of mood regulators like our good friend GABA.

As the keen-eyed may have noticed, these are all depression-related issues that keto might help with.

Even better: The way you burn energy on the keto diet might be inherently anti-inflammatory.

More research is needed, but eating keto might help prevent depression-generating complications of inflammation or even prevent the inflammation itself.

Probably not. But that doesn’t mean your feelings of sadness or irritability aren’t real.

Not everyone feels good while on keto. Ever heard of keto headaches? Keto breath? And then there’s so-called keto depression.

Let’s look at some potential explanations.

It could be keto flu

What’s a surefire way to feel bummed out? Keto flu.

The ketogenic diet aims to put your body into ketosis, which happens when you switch over from burning carbs for energy to burning fat.

Ketosis isn’t easy for all bodies. Sometimes the transition can cause headaches, cramps, fatigue, and sleep disruptions.

Then there’s the fact that ketogenic diets are often doctor-prescribed — meaning the people following the diet may not always be so excited about it. Unhappiness about your food choices + flu-like symptoms = a bad mood.

It could be a nutritional deficiency

Drastically changing your diet can cause a sudden drop in nutrients like zinc, magnesium, and selenium. Low levels of these micronutrients have been linked to — you guessed it — depression.

Bottom line: Keto depression is not a recognized medical condition. We don’t yet know whether it’s a biological response to ketosis or a reaction to a restrictive, disruptive lifestyle change. If it is biological, it might be due to micronutrient deficiencies.

Keto doesn’t cause depression, but it can affect your energy levels and mood. If you’ve got a case of the keto blues, you’ve got options.

  • Stop the diet. If eating keto makes you feel super sad, lethargic, or irritated, stop eating keto. If your doctor prescribed the diet, talk with them about alternatives. If you started it voluntarily, you can stop. Ketosis isn’t the only path to weight loss.
  • Try cyclic keto dieting (carb cycling). Don’t want the keto blues to stop you? Try a gentler diet, like eating keto most of the week but easing up for a day or two to fuel up with carbs.
  • Ride out the keto flu. Keto flu isn’t permanent. Your body will adjust, and the symptoms will decrease. You can help shorten the duration by drinking plenty of electrolyte-packed fluids.
  • Make it fun. Any restrictive diet can make you feel low. And cutting out whole food groups (buh-bye, carbs) can lead to nutrient deficiencies. So go all-in on your favorite veggies, meats, and healthy fats. Research suggests that learning to cook can help lift a low mood too.
  • Pick a different plan. Consider other, less restrictive diets, such as the Mediterranean diet. It’s also good for your gut and brain.

Keto doesn’t cause depression, but it can still mess with your mood.

The keto diet can make you feel physically crappy, especially if you don’t get enough nutrients. It’s also pretty restrictive. These factors might lead to the “keto depression” that some folks report experiencing.

A growing body of research suggests that ketogenic diets may help manage some depressive disorders. But more studies are needed to understand whether eating keto would benefit folks with situational sadness, irritability, or mood dysregulation.

If you’re dealing with chronic sadness, irritability, or other signs of depression, it’s important to ask for help. A healthcare professional can discuss potential treatments, including dietary changes that might help you feel better.

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Organic personal care products market surging at a growth rate of 9.2% by 2027 – Digital Journal

Increasing inclination among people from across the globe toward using organic products is creating substantial growth prospects in the global organic personal care products market. Moreover, improving standard of living as well as spending power of people from developed and developing nations in prognosticated to help in driving the sales of organic personal care products in the near future.

With increase in understanding on disadvantages of using chemical-based personal care products, major populace from several developing nations is growing preference toward the use of organic sun care, hair care, and facial care products. This factor is bolstering the demand for organic personal care products.

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Presence of Leading Players in North America to Help in Market Expansion

Europe, North America, Asia Pacific, and rest of the world are some of the key regions contributing to the growth trajectory of the global organic personal care products market. Among all regions, North America is anticipated to experience high sales opportunities in the upcoming years owing to factors such as presence of many leading organic personal care products manufacturers in the region and increase in understanding among regional populace about the advantages of using organic personal care products.

Federal governments of numerous nations, specifically in Europe and North America, are introducing new regulations and standards pertaining to personal care products. This factor is working well for the growth of the organic personal care products market in these regions.

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Manufacturers Launch Innovative Products to Cater to Consumer Needs

Some of the key players in the global market include Estee Lauder, The Hain Celestial Group, The Body Shop, and Yves Rocher. Organic personal care products manufacturers are increasing cash in-flow toward R&D projects, which are focused on developing innovative products. Furthermore, these strategies are also assisting companies to cater to evolving demands of their consumers and strengthen product portfolios.

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Many market players are taking help of marketing campaigns in order to grow awareness about their products and to attract new customers. On the back of these efforts, analysts at TMR project the global organic personal care products market to register growth at a CAGR of 9.2% in the forecast period of 2019 to 2027.

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