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Washington, D.C.—The Council for Responsible Nutrition (CRN) shared initial findings from its 2021 Consumer Survey on Dietary Supplements during its NOW, NEW, NEXT 2021 event. The major takeaway: 4 in 5 Americans now use supplements. That’s a 7-point increase over 2020, and it’s the all-time high since CRN has been conducting this survey.

“Supplement usage among Americans has steadily increased in the more than 20 years CRN has conducted the survey,” said Brian Wommack, CRN’s senior vice president of communications, in a release outlining the findings. “With 80% of Americans now using supplements, these products are now mainstream and broadly accepted by the American public. Just as important, 79% of Americans believe the dietary supplement industry is trustworthy, a jump of 5 percentage points from 2020.”

More highlights from the survey:

• 50% of supplement users reported a change to their supplement routine since the COVID-19 pandemic started
• 55% of those who reported a change said it included adding new supplements to their existing routine.
• Hispanic Americans were most likely to report a change in their supplement routine, significantly more so than white and Asian American/Pacific Islander respondents.

What are people taking? In presenting the data to event attendees, Tom Druke, Marketing Director, Minerals & Nutrients, Balchem noted that the supplement users surveyed are multiproduct users, which he noted is a good sign. Wommack noted that the focus has traditionally been on filling nutrient gaps, but there is an opportunity here to focus on optimizing overall health.

Taking a closer look at trending nutrients:

• Over the past 12 months, vitamin D usage significantly increased since 2020, up 10 percentage points (52% vs. 42% in 2020).
• Zinc increased to 22%, up from 15% in 2020.
• Vitamin C increased to 40%, compared to 35% in 2020.
• Hispanics are most likely to report a change in their supplement routine.

And why are they supplementing? Druke explained that 44% are taking nutritional supplements for overall health and wellness. Immune health is the driving reason for 36% of respondents, while 28% cited energy, 27% said they were filling nutrient gaps, and 26% are supplementing for hair/skin/nail health.

In another positive sign, 79% of adults surveyed said they believe the dietary supplement industry is trustworthy, and 94% of supplement users feel confident in the effectiveness of dietary supplements, while 96% are confident in the safety and quality of supplements.

The survey also looks at branded ingredients for the first time, showing consumers to find added value and are willing to pay for that quality.

About the 2021 survey: It was fielded for CRN by Ipsos August 20–26, 2021 and included a national sample of 3,089 adults aged 18 and older living in the United States, including 2,421 adults who consume dietary supplements seasonally, occasionally, or regularly. For  details, and to purchase the complete set of consumer survey data, get more information here.

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Washington, D.C.—After more than a decade of service to the Organic Trade Association (OTA) and the organic community, CEO Laura Batcha plans to step down in spring 2022. The trade association announced that it has hired global organizational consulting firm Korn Ferry to lead its search for a new CEO and Executive Director.

OTA looked back at Batcha’s “legacy of success,” noting that during her tenure, the size and scope of OTA expanded substantially. Batch is credited with building a team of expert staff, expanding opportunities for member engagement, and establishing OTA’s DC office and government relations arm. Batcha steered the association through three farm bills and multiple presidential administrations, OTA shared, and played a key role in positioning OTA as the voice of organic on the Hill.

“The growth of our association and across the organic community during Laura’s tenure has been nothing short of spectacular,” said Board Member Paul Schiefer of Amy’s Kitchen, in a press release. “Since Laura took the helm in 2014, OTA has been able to attract new partners at every scale and at every position along the value chain.”

“If there’s one thing I’m feeling right now, it’s confident,” added Batcha. “Confident in my team at OTA, confident in the great folks at Korn Ferry who we’ve brought on to help with our search, and confident that the next person we select to lead this organization is going to bring a new outlook, fresh ideas, and a dedication to moving organic forward.”

Looking to the future of the OTC, Batcha added: “Our work at the Organic Trade Association is always evolving, and I’m proud that we have the team in place—as well as support from our membership—to tackle the difficult issues that must be addressed in order for our industry to grow and move forward.”

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Washington, D.C.—President Biden has nominated Robert M. Califf, M.D., for Commissioner of the FDA.

FDA hasn’t had a permanent chief since President Biden took office, reports the New York Times, and acting FDA Commissioner Dr. Janet Woodcock is nearing the end of the term that acting officials are allowed to serve.

Dr. Califf is a Cardiologist who teaches at the Duke University School of Medicine. He served briefly as FDA Commissioner at the end of Barack Obama’s second term, from February 2016 to January 2017, and before that, was Deputy Commissioner for medical products and tobacco.

The Council for Responsible Nutrition (CRN) applauded the nomination. “CRN congratulates Dr. Robert M. Califf for being nominated to lead FDA as its next commissioner,” said Steve Mister, President and CEO. “We look forward to working with Dr. Califf to strengthen the dietary supplement industry and protect consumers by ensuring products are safe and meet regulatory requirements.”

Related: Leadership Change at Office of Dietary Supplement Programs
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CRN pointed to six action items that would strengthen the dietary supplement and functional foods industry:

1. Increase funding to the Office of Dietary Supplement Programs (ODSP) at FDA, recognizing this Office must keep pace with the rapidly growing industry it oversees
2. Work with Congress to enact legislation to establish mandatory product listing for supplements
3. Establish a legal pathway to market for hemp-derived cannabidiol (CBD) as a dietary supplement
4. Issue final guidance on the labeling of probiotics
5. Issue final guidance for new dietary ingredients, along with an official list of pre-DSHEA dietary ingredients that are “grandfathered” under the 1994 law
6. Protect consumers and strengthen incentives for innovation with more proactive enforcement of the existing law for dietary supplements

Mister continued: “CRN has enjoyed a strong working relationship with FDA and looks forward to continuing this relationship under Dr. Califf’s leadership. Together, we will continue growing an innovative and safe marketplace for dietary supplements that protect consumers, while avoiding unwarranted regulatory burdens for the industry.”

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Washington, D.C.—The Federal Trade Commission (FTC) has sent out a Notice of Penalty Offenses warning more than 700 recipients against using fake reviews and other misleading endorsements, according to an FTC statement. Nor is the Notice just an alert: It changes how FTC can penalize businesses that fail to comply.

Social media, use of influencers for sponsored content, and outright fake online reviews have blurred the line between advertising and authentic content, leading to what FTC calls an “explosion in deceptive endorsements” across the marketplace. To combat this, FTC is now using its Penalty Offense Authority: By sending a Notice of Penalty Offenses, the agency is opening up the possibility of seeking civil penalties against companies that engage in conduct that they know has been found unlawful in previous FTC administrative orders.

Ivan Wasserman, Managing Partner, Amin Talati Wasserman, explained this move to WholeFoods: “Under the FTC Act, the FTC actually does not have the general authority to obtain civil penalties for deceptive marketing practices such as the deceptive of endorsements and reviews. When you saw companies paying big amounts to the FTC in recent years for making false, misleading, or unsubstantiated claims about foods and dietary supplements, those have generally not been civil penalties. They have been what is known as ‘equitable’ relief, typically in the form of providing restitution to consumers who purchased the product as a result of the deceptive claims. However, last April the Supreme Court’s decision in a case called AMG Capital Management v. FTC held that the FTC cannot obtain such relief in a court action. Yesterday’s action is an attempt by FTC to get around all of that—at least for the 700 companies who received the notice. A ‘Notice of Penalty Offense’ such as this identifies conduct that the FTC has determined, in prior administrative orders, violates the FTC Act.  A company that engages in that conduct after receiving a notice may be subject to civil penalties of up to $43,792 per violation.”

Importantly, the letter is not a notice that an offense has been committed—the businesses that receive it may not have committed any offense at all. It is, explicitly, intended to deter misconduct.

The offenses outlined in the Notice include:

• falsely claiming an endorsement by a third party
• misrepresenting whether an endorser is an actual, current, or recent user
• using an endorsement to make deceptive performance claims
• failing to disclose an unexpected material connection with an endorser
• misrepresenting that the experience of endorsers represents consumers’ typical or ordinary experience

“Fake reviews and other forms of deceptive endorsements cheat consumers and undercut honest businesses,” said Samuel Levine, Director of the FTC’s Bureau of Consumer Protection, in the press release. “Advertisers will pay a price if they engage in these deceptive practices.”

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Companies receiving the notice include Amazon, Abbott Laboratories, Annie’s, Applegate Farms, Chobani, Conagra Brands, Del Monte Foods, Frito-Lay North America, Hershey, Hormel Foods, Kellogg, Kraft Heinz, Kroger, Mars, Nestlé, PepsiCo, POM Wonderful, Quaker, Schmidt’s Deodorant, SmartyPants Vitamins, Coca-Cola, Tom’s of Maine, Tyson, Unilever, Whole Foods Market, and many, many more, across every sector of the marketplace.

“This represents the FTC’s proverbial ‘shot across the bow’ warning to all marketers to knock it off with the rampant use of fraudulent endorsements and reviews on the internet,” Wasserman commented. “Whether against any of the 700 companies that received the notices or not, I expect to see increased enforcement by the FTC in this area in the coming years, so it is critical for companies of all sizes to understand the rules, and have policies and procedures in place to ensure that they follow them.”

FTC noted that the agency has created multiple resources for businesses to ensure that they are following the law when using endorsements for advertising purposes.

“The online world is a great tool for business, but like many tools, it gets developed and exploited before the guard rails catch up,” commented Len Monheit, CEO, Trust Transparency Center. “In this case, FTC is catching up to exploitive practices that take advantage of consumer vulnerability. More companies need to take a long view and operate with the principles of Trust Transparency as then this type of notice wouldn’t be needed. It’s good to see FTC taking action to clean up misleading claims as they hurt consumer trust.”

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Silver Spring, MD—The American Herbal Products Association (AHPA) announced that it has joined the Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) in calling on the Food and Drug Administration (FDA) to clarify that N-acetyl cysteine (NAC) is a lawful dietary ingredient.

As WholeFoods previously reported, despite decades on the marker as a dietary supplement, in July 2020, FDA issued multiple warning letters asserting that products containing NAC cannot be marketed as supplements, due to the drug preclusion clause of the FD&C Act, which states that supplements cannot contain articles that FDA has approved as a drug, unless the ingredient was used before it was tested as a drug. WholeFoods legal editor Scott C. Tips addressed the issue in his Legal Tips column, outlining legal arguments that “destroy the FDA’s stance on NAC.” His conclusion: “As NPA has correctly pointed out, there has been no final agency action taken on NAC sales. So, why are so many companies dashing for the exit doors? Stand and fight. And win.” Read the full column here.

AHPA joined with other industry groups and experts in questioning FDA’s action by submitting comments to each of two dockets created for citizen petitions submitted by CRN in June 2021 and by NPA in August 2021. In its comments, AHPA said it cites “extensive legal authority to refute FDA’s apparent position that the so-called prior drug exclusion provision applies retroactively to ingredients that were already in the food supply at the time of DSHEA’s enactment, such as NAC.”

Strengthening the industry’s stance, AHPA also pointed to several specific NAC-containing dietary supplements that were in the U.S. market prior to enactment of DSHEA.

“AHPA has retained and collated numerous pre-DSHEA records that document actual marketing in the U.S. before 1994 of thousands of ingredients and finished products,” said Michael McGuffin, AHPA President. “We were able to access the extensive records in this AHPA ODI Documents Database to provide affirmative documentation that NAC—just like vitamin C and vitamin D—was already being sold in the U.S. before the prior-drug approval restriction became law.”

AHPA’s comments to the NPA citizen petition can be accessed here; and the comments to the CRN citizen petition are available here.

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Los Angeles, CA—California Governor Gavin Newsom has signed a bill explicitly legalizing and regulating cannabidiol (CBD).

A Politico article explains that all involved—hemp, cannabis, and dietary supplement industry members—have agreed on a proposal, now known as CA AB 45 (21R), which would allow CBD and other parts of the hemp plant to be included in food, beverages, and cosmetics, while prohibiting all forms of THC in hemp products. The proposal will establish fees to fund enforcement, and give state public health officials the authority to seize products that fail testing standards at any point in the supply chain. It will also create a database of licensed manufacturers, which law enforcement officials can use to check on products on shelves.

AB 45 will also require that hemp imports meet California standards, and will subject out-of-state facilities to CDPH inspections.

Politico quoted bill author Assembly Member Cecilia Aguiar-Curry (D-Winters): “The product is everywhere. You can walk into a World Market, a health food store, a pet store, and you’ll see CBD there. There’s no labeling, it doesn’t tell you if it’s safe. So, I want to make sure that people know what they’re purchasing.”

However, this isn’t the end of the story. Politico reports that this fight has taken so long in part because the hemp and cannabis industries have disagreed on whether to allow inhalable hemp products, which the cannabis industry is against—and, therefore, Newsom, a cannabis ally, also sought to ban the products. The bill didn’t ban them outright, but put a freeze on them until the Legislature enacts a new tax on them; manufacturers will be able to export inhalable hemp to other states. Small hemp cultivators that primarily grow smokable hemp weren’t happy with the freeze. Politico quoted Chris Boucher, a HFG board member and longtime hemp grower: ““I think it’s just disastrous, and they did it right at harvest time. You spend millions of dollars on equipment, greenhouses, processing equipment, labor, and you can’t sell your crop in California. That was really just a punch in the face.”

And that’s not a small setback. Pointing to Statista, Politico reports that California accounted for $730 million in CBD sales in 2019, 2.5 times more than any other state. That’s good and bad. It means that hemp growers like Boucher, looking to sell smokable products, have lost access—if temporarily—to the biggest market in the country. But it also means that anyone looking to sell in California will have to shape up their entire supply chain, potentially making the industry safer country-wide.

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The U.S. Hemp Roundtable has released a statement on the topic, writing: “The era of CBD prohibition in California is over… We are grateful to all of our Hemp Supporters who helped make this victory possible California. When we lift our voices, we win!”

And the group is already looking to the future, stating: “Soon, the California Department of Public Health will promulgate emergency regulations to implement the program. Subsequently, legislation will be introduced in the 2022 legislative session to address open questions such as the tax regime on smokable hemp products. The U.S. Hemp Roundtable will be fully engaged throughout this process.”

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Silver Spring, MD—Cara Welch, Ph.D., has stepped down as Acting Director of the Office of Dietary Supplement Programs (ODSP), and Greg Noonan, Ph.D., has taken the post.

The Council of Responsible Nutrition (CRN) wrote in the association’s Daily Supplement that this isn’t a comment on Dr. Welch’s performance, but a mandated switch to ensure that acting directors don’t hold a post for too long.

CRN is calling for a permanent director to be named, noting that it’s difficult to handle big-ticket items including CBD, NAC, NDI draft guidance, and mandatory product listing without someone holding that top position.

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Silver Spring, MD—FDA has released a consumer update listing five things the agency wants consumers to know about Delta-8 THC (tetrahydrocannabinol), a psychoactive substance found in both marijuana and hemp.

The five things on FDA’s list include:

1. Delta-8 THC products have not been evaluated or approved by FDA for safe use in any context, and can have dangerous marketing: Variability in product formulations and product labeling, other cannabinoid and terpene content, and differing delta-8 THC concentrations can all cause different and unknown effects in a consumer. Some products may simply be labeled “hemp products,” which may mislead consumers who are looking for non-psychoactive products.
2. FDA received adverse event reports between December 2020 and July 2021 describing 22 patients who consumed delta-8 THC. Of these, 19 experienced adverse events after ingesting food containing delta-8. 14 went to a hospital or emergency room for treatment after consumption of delta-8. Adverse events included vomiting, hallucinations, trouble standing, and loss of consciousness. National poison control centers received 661 exposure cases of delta-8 between January 2018 and July 31, 2021, 660 of which occurred in 2021. Of the 661 cases, 41% involved unintentional exposure to delta-8, and 18% required hospitalizations, including children who required ICU admission.
3. Delta-8 has psychoactive and intoxicating effects. Products containing delta-8 may have much higher levels of the substance than are naturally occurring in raw extracts of hemp, so historical data on use and consumption of cannabis and hemp can’t be used to predict a reaction to or the safety of a delta-8 product.
4. Production of delta-8 products may require potentially harmful chemicals, in order to create a product with the concentration claimed on the label. Besides the safety of the chemicals used to actually concentrate the product, the chemicals may have byproducts that end up in the final product.
5. Delta-8 products may be packaged in a way that appeal to children—as gummies, chocolates, cookies, and more. Looking back at the statistics from national poison control centers, of the 41% of cases involving unintentional exposure, 77% affected pediatric patients less than 18 years of age. 39% of all exposure cases affected pediatric patients. These products should be kept out of reach of children and pets.

The full statement is available here.

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As WholeFoods has previously reported, the industry is divided on delta-8. The U.S. Hemp Authority, for instance, will not certify hemp products marketed for an intoxicating effect. In March 2021, Dr. Marielle Weintraub, President of the U.S. Hemp Authority, said: “Recent press reports about the proliferation of potentially unsafe, intoxicating products calling themselves hemp have concerned consumers, retailers, law enforcement and policymakers. We felt it was necessary to take a strong stand against these products so that people will know that the U.S. Hemp Authority seal designates products that are truly hemp and that meet our rigorous standards.”

The U.S. Hemp Roundtable, too, made its stance on delta-8 clear in a statement also made in March: “Unlike marijuana, hemp is, by definition, not intoxicating. Rather hemp products like CBD are popularly used by consumers to benefit their general health and wellness, not to get them high. Adult-use cannabis products, which feature concentrated THC and are intended for intoxication, should not be marketed as dietary supplements, and should be subject to a distinct regulatory pathway. We look forward to working with Congress and federal agencies to develop responsible laws and regulations to provide separate pathways and proper guardrails to distinguish these products.”

The American Herbal Products Association (AHPA), adopted a guidance policy in June that points out that “hemp” is defined by federal law as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent (0.3%) on a dry weight basis,” and notes that no other cannabinoid is subject to the same quantitative limit that delta-9 is. AHPA therefore took a stance not against naturally occurring delta-8, but against “concentrations in excess of the naturally occurring level in hemp” and synthetic or artificial cannabinoids, including synthetic delta-8.

The Hemp Industries Association (HIA) took the position that delta-8 THC, along with all other hemp-derived cannabinoids, were federally legalized by the 2018 Farm Bill. “Businesses, farmers, and consumers all deserve regulations that support the exploration of the hemp plant’s full potential. This isn’t just about one minor cannabinoid —the list is over a hundred already and growing,” said Jody McGinness, HIA’s Executive Director, in the press release. “Fortunately, the industry has all the expertise legislators could need, and those manufacturing leaders and scientists are engaged and ready to help create productive policy solutions.” The HIA cited a legal opinion drafted by attorneys Rod Kight and Philip Snow of Kight Law.

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Washington, D.C.—The FDA and FTC have posted warning letters to 10 companies for illegally selling dietary supplements claiming to cure, treat, mitigate, or prevent diabetes.

“More than 34 million Americans— just over 1 in 10 people— are living with diabetes. Dietary supplements that make fraudulent claims to treat diabetes are unapproved new drugs that could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments,” said Cara Welch, Ph.D., Acting Director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition, in a statement. “The FDA is committed to protecting U.S. consumers from products and companies that make unlawful claims to treat or prevent diabetes, and we’ll continue to hold companies accountable by alerting the public about products that place consumers at risk.”

The warning letters were issued to: Live Good Inc.; Pharmaganics LLC; Lysulin Inc.; Nuturna International LLC; Phytage Labs; Ar-Rahmah Pharm LLC; Metamune Inc.; Holistic Healer & Wellness Center Inc.; Radhanite LLC; and Aceva LLC.

FDA’s warning letters cited claims such as:

• “[Product] helps improve insulin sensitivity and enhance blood sugar control.”
• “For improved A1c levels and glycemic control.”
• “The anti-diabetic properties of the ingredients contained in [product] work their best to support the fight against Type 2 diabetes and a number of other possible health ailments, before their onset.”
• “[C]onquers insulin resistance and also shown to be useful in the treatment of certain classes of non-insulin-dependent diabetes”
• “The combination and high level of these active ingredients have been shown to help maintain healthy A1c blood sugar levels in diabetics and prediabetics.”

FDA also cited social media statements, such as “If you need to decrease your body’s need for insulin, use [product]”; “help get your Diabetes under control”; and “clinically shown to help people with diabetes or pre-diabetes…works like a sponge to remove Glucose from your bloodstream.”

FDA further pointed to customer testimonials, such as reviews stating that a product had helped a user lower their HbA1c levels.

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FDA has requested responses from the companies within 15 working days, stating how they will address these issues or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to promptly correct violations may result in legal action, including product seizure.

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