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Educating and Informing the Natural Products Industry
Updated: 1 hour 34 min ago

NPA Points to Flawed Thinking in USPSTF Report on Dietary Supplements

June 23, 2022 - 6:16am

Washington, D.C.—The United States Preventive Services Task Force (USPSTF) has determined there is “insufficient evidence” that taking multivitamins, paired supplements, or single supplements can help prevent cardiovascular disease and cancer in otherwise healthy, non-pregnant adults.

As WholeFoods Magazine reported, USPSTF specifically recommends against taking beta-carotene supplements. They also advise against vitamin E supplements, saying “it has no net benefit in reducing mortality, cardiovascular disease or cancer.”

NPA Points to a Flaw in the Logic

In response to USPSTF’s report, Daniel Fabricant, Ph.D., President and CEO of the Natural Products Association (NPA), issued a statement.

“This is no surprise to anyone in the dietary supplement industry,” said Dr. Fabricant. “Any manufacturer claiming that the products could have these kinds of effects would be in violation of laws against false claims.

Dr. Fabricant noted that the USPSTF plays an important role in the federal government’s approach to health care and reimbursement considerations. But, he said, “this research is akin to studying a hammer and concluding it is unsuitable for turning a screw. Dietary supplement manufacturers are prohibited from saying their products would help prevent cardiovascular disease or cancer because they cannot, plain and simple.”

The Council for Responsible Nutrition (CRN) and Consumer Healthcare Products Association (CHPA) also released statements. Read their perspectives here.

Related: Vitamins a “Waste of Money” for Most Americans? Industry Responds
NPA Responds to CDC’s Data on Melatonin
Dietary Supplement Listing Act of 2022 Introduced; Industry Divided

 

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Vitamins a “Waste of Money” for Most Americans? CRN Responds

June 21, 2022 - 12:31pm

Washington, D.C.—In 2021, U.S. consumers spent close to $50 billion on vitamins and dietary supplements, according to a release from Northwestern University. But, Northwestern Medicine scientists say, there isn’t enough evidence that vitamins help prevent cardiovascular disease or cancer. And because of that, they concluded, vitamins are “a waste of money” for non-pregnant, otherwise healthy Americans.

“Patients ask all the time, ‘What supplements should I be taking?’” said Dr. Jeffrey Linder, Chief of General Internal Medicine in the Department of Medicine at Northwestern University Feinberg School of Medicine, in the release. “They’re wasting money and focus thinking there has to be a magic set of pills that will keep them healthy when we should all be following the evidence-based practices of eating healthy and exercising.”

USPSTF Guidelines

Northwestern Medicine scientists outlined their case against vitamins in an editorial published in JAMA. They support new recommendations from the United States Preventive Services Task Force (USPSTF), which makes recommendations about clinical preventive services. USPSTF’s new guidelines deemed there is “insufficient evidence” that taking multivitamins, paired supplements, or single supplements can help prevent cardiovascular disease and cancer in otherwise healthy, non-pregnant adults.

Northwestern said USPSTF is specifically recommending against taking beta-carotene supplements. The reason given: a possible increased risk of lung cancer. Also, they recommend against taking vitamin E supplements. They say “it has no net benefit in reducing mortality, cardiovascular disease or cancer.”

Dr. Linder noted: “The harm is that talking with patients about supplements during the very limited time we get to see them, we’re missing out on counseling about how to really reduce cardiovascular risks, like through exercise or smoking cessation.”

CRN Responds

Council for Responsible Nutrition (CRN) issued a statement regarding the U.S. Preventive Services Task Force guidance on multivitamins.

“Numerous research studies support the use of multivitamins by most Americans for a range of benefits,” said Andrea Wong, Ph.D., Senior Vice President, Scientific & Regulatory Affairs. “First, multivitamins fill in significant nutrition gaps in Americans. Government data shows that most Americans fall short in many key nutrients. In fact, the Food and Drug Administration and the 2020–2025 Dietary Guidelines for Americans identified that under-consumption of calcium, potassium, dietary fiber, and vitamin D is of public health concern for the general U.S. population because low intakes are associated with numerous health concerns.”

Second, Dr. Wong continued, “the recent Cocoa Supplement and Multivitamin Outcomes Study (COSMOS) is among the growing evidence that multivitamins help delay cognitive decline in older people.”

Dr. Wong also pointed to results of the Physicians’ Health Study II. This large-scale, randomized, double-blind, placebo-controlled trial showed an 8% reduction in overall cancer risk in older male physicians who took a multivitamin.

“These are just a few of the many benefits from multivitamins, not to mention the benefits from individual ingredients that are in the multivitamin like B vitamins, vitamin D, etc.,” Dr. Wong said. “The apparent limited evidence should not be misinterpreted as the absence of evidence.”

Related: CRN: News Reports “Grossly Misrepresent” CDC Report on Melatonin
Dietary Supplement Listing Act of 2022 Introduced; Industry Divided

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Senate HELP FDA Authorization Bill Passes Committee; Industry Groups “Strongly Concerned”

June 15, 2022 - 7:17am

Washington, D.C.—Earlier this year, the Senate Health, Education, Labor, and Pensions (HELP) Committee released a discussion draft of legislation to reauthorize FDA user fees for drugs, biologics, and medical devices—and the legislation includes the Durbin-Braun premarket approval concept.

As WholeFoods Magazine reported, the Natural Products Association (NPA) has been cautioning that this would be damaging to the industry. In a series of letters, NPA requested that the Senate HELP committee strike the entire dietary supplement section of the Food and Drug Administration Safety and Landmark Advancement (FDASLA) Act of 2022 (S.4348). Alternatively, NPA asked for the inclusion of provisions that prohibit FDA from excluding or removing products from the listing unless and until the product is subject to final agency action.

Daniel Fabricant, Ph.D., President and CEO, explained NPA’s concerns. “The reauthorization of the FDA user fee program is not the appropriate vehicle to include controversial dietary supplement legislation, especially since it has not undergone the appropriate committee review and debate,” Dr. Fabricant said. “A public database as proposed in the FDASLA is completely inconsistent with the facility registration provisions of the Bioterrorism Act. Twenty years ago, Congress decided there was a compelling reason to protect specific information about dietary supplement production from falling into the hands of people with malicious intent. The current version of the FDASLA insufficiently shields critical pieces of information.”

Industry Takes Action

NPA launched a grassroots campaign to fight the legislation. “Over 100,000 constituents have contacted to register their strong opposition to the dietary supplement provisions in the FDASLA,” Dr. Fabricant shared. “Our industry has never been required to pay user fees, nor do we have pre-emption from state tort claims that exist for other FDA-regulated products. Prohibiting the FDA from excluding or removing products from the listing unless there is final agency action is the only way the industry can preserve any due-process rights against the agency should a dispute arrive, like the current disputes over cannabidiol (CBD), N-acetyl cysteine (NAC). Otherwise, the agency could still use MPL as a basis to deny or de-list products containing disputed ingredients, even if the ‘prohibited act’ language discussed earlier were removed and even with the addition of the language about premarket approval.”

Legislation Advances

On June 14, the Senate HELP Committee passed FDASLA.

NPA stressed that that the legislation removes protections for dietary supplement manufacturers under the Bioterrorism Act and would allow  FDA to “administratively, without checks and balances, reject ingredients like CBD and NAC from being marketed as dietary supplements, regardless of the science or history involved.”

Regarding this latest development, Dr. Fabricant said: “We are disappointed that the significant economic, consumer, and security-related concerns that have been raised by NPA, other experts and thousands of American constituents, have to this point, appear to have fallen on deaf ears. We will redouble our efforts to continue educating members and staff about the deep negative impact of these provisions in hopes that we can get a fair hearing as the legislative process unfolds.”

Dr. Fabricant added, “We’re pleased the House in its wisdom did not include any of these unwise and dangerous provisions in its version of this legislation, and we are asking the Senate to reject these provisions on the floor when it comes for a full vote and the House to reject these Senate provisions in any final agreement between the chambers.”

CHPA “Strongly Concerned”

Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville released statement today following the Senate HELP Committee’s passage of the FDA Safety and Landmark Advancement (FDASLA) Act of 2022. “While CHPA remains highly supportive of an appropriate listing system for dietary supplements that will enhance consumer safety, we are strongly concerned that the dietary supplement provisions of this legislation are overly broad and will place unnecessary and costly burdens on the entire industry,” Melville said. “Moreover, the legislation falls short of the comprehensive reforms needed to appropriately and effectively modernize the regulatory framework for dietary supplements.

 “CHPA remains committed to working with congressional leaders in both parties on an appropriate listing system that paves the way for increased visibility into the dietary supplement marketplace, while also providing consumers with the assurances they deserve regarding dietary supplements sold in the United States.”

NPA Calls for Grassroots Action

NPA again stressed the importance of action. The organization encouraged all health and wellness advocates to continue writing their members of Congress through the NPA Action Center. As NPA noted, “Grassroots involvement has been critical and continued pressure is needed to defeat this proposal.”

Related: Dietary Supplement Listing Act of 2022 Introduced; Industry Divided
What is “Mandatory Product Listing”?
Senator Durbin is Coming for Your Supplements
 

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CRN: Media Coverage “Grossly Misrepresent” CDC Report on Melatonin

June 9, 2022 - 5:50am

Washington, D.C.—As WholeFoods Magazine previously reported, the Centers for Disease Control (CDC) recently released data regarding the use of melatonin in children. The study authors reported that:

  • During 2012–2021, the annual number of pediatric ingestions of melatonin increased 530% (a total of 260,435 ingestions reported)
  • Pediatric hospitalizations and more serious outcomes also increased, primarily because of an increase in unintentional melatonin ingestions in children aged ≤5 years.
  • In 2020, melatonin became the most frequently ingested substance among children reported to national poison control centers.

Mainstream media coverage following the CDC report featured headlines such as “melatonin poisoning in kids have spiked dramatically” and “melatonin overdoses in kids skyrocketed in last decade.”

CRN Responds to Inaccurate Headlines

The negative media coverage prompted the the Council for Responsible Nutrition (CRN) to a statement in response to articles falsely reporting on the CDC.

“As a toxicologist, I am disturbed by recent headlines claiming melatonin ‘poisoning’ in children rose 530% in 10 years—that is simply inaccurate,” stated CRN’s Andrea Wong, Ph.D., Senior Vice President, Scientific & Regulatory Affairs. “These news stories grossly misrepresent the CDC investigation and raise undue alarm.

“When a parent calls a poison control center about their child possibly ingesting a substance, that call gets counted as an ingestion report regardless of the medical outcome. The mere act of calling a poison control center to inquire about accidental ingestion does not mean that a poisoning or other adverse event occurred.”

CRN Clarifies the CDC Findings on Melatonin

Dr. Wong offered clarity on the CDC data. She explained: “The CDC study shows 98% of the reports of melatonin ingestion had an outcome of no effect or minor effect, and the overwhelming majority of children (83%) were completely asymptomatic. For the few reports associated with an adverse outcome, it is not possible to confirm whether the outcomes were caused by melatonin ingestion since poison control data does not include patient medical records.

“The fact is melatonin is a beneficial dietary supplement that helps to adjust our internal body clocks that regulate sleep and is safe when used as directed.”

Melatonin Use on the Rise

CDC pointed to melatonin’s popularity as a reason for the increased pediatric exposure. “It is cost-effective and offers an OTC therapeutic alternative to enhance sleep without use of potentially habit-forming sedative-hypnotics,” the authors noted. “Consequently, its use has increased in both adults and children. In addition, growth in the national melatonin market has occurred in response to public demand, with sales in the United States increasing by approximately 150% between 2016 and 2020. Increased sales, availability, and widespread use have likely resulted in increased access and exposure risk among children in the home.”

CRN’s Dr. Wong noted that news reporting on the increase in ingestion lacks context and misleads parents about potential dangers. “CRN’s own national consumer survey data reveals the number of Americans using melatonin more than doubled from 5% of adults in 2012 to 11% of adults in 2021. The CDC notes that the year of greatest increase in reports was between 2019 and 2020, when poison control center ingestion reports increased by 37.9%. During that same period, melatonin sales increased by close to 40%, according to two different industry reports. Unavoidably, more use means more possibilities for accidental ingestion.

“As a toxicologist—and a parent—I took two key points from the CDC research: First, parents should talk to their children’s healthcare providers about whether melatonin supplements may be helpful, the appropriate dose, and duration of use. Also, parents must remember to keep all supplements out of children’s reach and to follow the directions for use on the label.”

NPA, CHPA Respond to CDC’s Melatonin Report

The Natural Products Association (NPA) and the Consumer Healthcare Products Association (CHPA) also issued statements regarding the CDC report:

Related: CHPA Responds to JAMA Report on Melatonin Usage
CRN Debunks Melatonin Myths

Dietary Supplement Listing Act of 2022 Introduced; Industry Divided

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Unilever Acquires Majority Share of Hair Growth Supplement Brand

June 1, 2022 - 8:51am

London, England—Unilever announced its majority stake of hair growth supplement and wellness brand Nutrafol. Unilever currently has a minority share at 13.2%, through its private equity arm, Unilever Ventures Ltd. Nutrafol, backed by the private equity firm L Catterton, will function with Unilever’s Health & Wellbeing unit. Its possession is contingent on regulatory approval.

“I am delighted to welcome Nutrafol to the Unilever family,” said Fernando Fernandez, President, Beauty and Wellbeing at Unilever, in a press release. “Nutrafol and its holistic approach to hair health is the perfect complement to our growing portfolio of innovative wellness and supplements brands.”

Giorgos Tsetis, Co-Founder and CEO of Nutrafol, added, “Joining forces with a leading global organization like Unilever, and all the resources and scale that comes with that, is the natural evolution in our mission to help people grow into their best selves through whole-body health. I am so thankful to the Nutrafol team for all we have accomplished together. The Unilever family will be a great home for us as we continue to move the industry forward with new innovations to support the needs of consumers at every point of their hair health journey.”

Related: SOS for Thinning Hair
Science Spotlight from Nutri-Beauty: Mastering the Market
Hair, Skin & Nails Benefit from Balanced Nutrition 

Roland Peralta, Co-founder, Chief Innovation and Product Officer of Nutrafol concluded, “When we founded Nutrafol in 2016 it was inspired by our own experiences with thinning hair and the inability to find a natural, yet efficacious way to take control of our hair health. Nutrafol couldn’t be just another untested alternative to hair drugs and vitamins. Now we are proud to offer a suite of best-in-class, clinically backed products that help customers easily navigate and take control of their individualized hair needs.”

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NPA: RI Senate Bill Would Raise Vitamin Prices and Strain Retailers

May 25, 2022 - 11:41am

Washington, D.C.—The Natural Products Association (NPA) shared news that the Rhode Island State Senate is quickly advancing Rhode Island Senate Bill 2613, which is currently on the agenda for a vote before the full Senate on Tuesday, May 31. The bill calls for limiting the accessibility of dietary supplements “to prevent the misuse or abuse of such products” and would required providing “a conspicuously posted notice at the purchase counter of the possible side effects of the supplements.” NPA noted that this legislation prohibits dietary supplements from being directly accessible to customers and mandates that only retail clerks may have access.

The bill does not regulate internet sales of dietary supplements in Rhode Island, NPA added, yet brick-and-mortar retailers would be required to post a warning sign at each purchase counter communicating that dietary supplements are known to cause serious adverse events, including stroke, organ failure, and even death. Failure to comply would result in a fine of up to $2,000 for each infraction.

“This is a terrible idea at the worst time,” said Daniel Fabricant, Ph.D., NPA President and CEO, in a press release. “As more Americans have turned to natural products for health and wellness during the pandemic, this bill would mean higher prices and longer wait times for consumers with absolutely zero health benefits. Retailers would be forced to move household items like multivitamins and nutrition products behind the counter or remodel their stores, and then hire more clerks when nearly everyone is struggling to find workers.  Meanwhile, OTC medicine would still be in front of the counter and many of the exact same ingredients would still be available in grocery stores, coffee, and smoothie shops in the form of vitamin fortified foods and beverages. It is unfair, unnecessary and unwise.”

Rhode Island consumers would be the negatively impacted, Dr. Fabricant added. The state treasury would also take a hit, he said, due to lower sales tax revenue. Who would benefit from the bill? Connecticut store owners. Dr. Fabricant noted, since Rhode Island shoppers will make the trip to buy their natural products without the barriers.

Another concern raised by NPA: Legislators did not follow through on earlier promises to study the issue further, and officials did not seek industry input on such a significant legislative proposal.

“The natural products industry has been completely shut out of the conversation, which has been the antithesis of a democratic process,” Dr. Fabricant said. “It’s incredibly disingenuous to say in one breath we need to study this issue more and then a month later bull-rush legislation through because the legislative session ends a month from now. If the Rhode Island legislative body has an ounce of integrity left, they would delay this vote to hear from the natural products industry. The FDA does not have a single datapoint that connects eating disorders to supplement use, and 80% of Americans take at least one dietary supplement as a safe, effective, and affordable way to maintain good health and augment inadequate diets. The industry is under attack at the state and federal levels. We cannot afford to sit silent if we want to ensure consumer access to natural products remains vibrant.”

As WholeFoods Magazine previously reported, NPA has been acting on multiple fronts to prevent this and other supplement restriction bills from becoming law in several different states. NPA is spearheading grassroots campaigns across the country against these bills. The association is urging natural products industry members to join the thousands of Rhode Island health and wellness advocates to contact their elected officials and warn them of the consequences of S.2613. NPA’s grassroots campaign can be accessed here.

Related: The Natural View: Regulatory Update with NPA’s Kyle Turk
Senator Durbin is Coming for Your Supplements
NPA Alerts DHS, HHS & DOJ to Concerns with Dietary Supplement Listing Act 

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Mandatory Product Listing Proposal Included in Draft Legislation; NPA Weighs In

May 19, 2022 - 6:21am

Washington, D.C.—The Senate Health, Education, Labor, and Pensions (HELP) Committee has released a discussion draft of its legislation to reauthorize FDA user fees for drugs, biologics, and medical devices—and the legislation includes the Durbin-Braun premarket approval concept. The Natural Products Association (NPA) is cautioning that this would be damaging to the industry.

Daniel Fabricant, Ph.D., President and CEO of NPA, called the legislation “radical and dangerous,” pointing out that it would weaken the Bioterrorism Act. “Last time I checked, dietary supplements are not drugs, biologics, or medical devices, so why is Congress or anyone supporting non-germane legislation that will only add costs to consumers who are doing all they can to stay healthy is extremely troubling? Groups who have supported this legislation have stated there are protections for technical disagreements with the FDA like those with hemp, CBD, NAC, and several other products. However, if this legislation were to pass, it is abundantly clear these products would be eliminated from the market.”

Related: Dietary Supplement Listing Act of 2022 Introduced; Industry Divided

Bioterrorism Concerns
The legislation would require supplement manufacturers to supply FDA with information not only about the product, but about the entire supply chain, which would then be made public. NPA’s concern is that this is in some cases redundant, in some cases pointless, and in some cases dangerous.

Speaking with WholeFoods Magazine, Dr. Fabricant explained: “This is completely at odds with the Bioterrorism Act. If this were to pass, people would have a complete record of all points in the supply chain in one electronic database. This would leave the safety of our supply chain totally vulnerable. Additionally, manufacturers have to list every place it is sold/retailed? What benefit is that? The FDA already has access to information regarding who is making dietary supplements, distributing them, what products are made at which facilities, when new ingredients are introduced into commerce, and whether any products are associated with serious adverse events. These requirements fall under facility registration, the Bioterrorism Act, structure/function claims, New Dietary Ingredient notifications, and adverse event reporting. Some of the information the FDA has at its disposal is not publicly available, and for a good reason.”

The legislation would fail to address the actual problem, according to Dr. Fabricant: FDA’s disorganization, and its failure or refusal to use the information already at its disposal.

Product Removal
The legislation states that it would be prohibited to introduce products into interstate commerce if they are marketed as a dietary supplement, but don’t meet the legal definition of a dietary supplement—which would hit cannabidiol (CBD), N-acetyl cysteine (NAC), and probiotics, to name a few.

Due to FDA’s insistence that those products aren’t dietary ingredients, “this is the biggest concern,” Dr. Fabricant told WholeFoods. “Because the bill is unclear, there is no way to remedy this in a timely manner. This is where FDA can, by not listing a product, effectively take away its ability to be sold on the market. Large retailers will use this list to decide whether they sell a product or not. So not appearing on the list due to a technical disagreement with FDA—not a dispute over safety or disease claims—could take away your whole business with the stroke of a keyboard. FDA has done nothing on CBD in four years, and with the tools provided in this bill, could wipe it out altogether due to the agency’s stance/interpretation on Section 201(ff)(3) of FDCA. If you have a new dietary ingredient notification and are compliant with the law, but FDA disagrees with your opinion on safety or daily dosage, do you think they’re going to list your product? Also, under this legislation, knockoff ingredients or copycat ingredients altered chemically can flood the market absent any action from the FDA. How is that a good thing?”

Increased Administrative Power
Dr. Fabricant adds that NAC should be a warning sign—while FDA has announced a policy of enforcement discretion, this bill would mean they wouldn’t have to bother. “The language here would be in direct contravention with 201(ff)(3). Anything that FDA says was a drug first, whether accurate or not, would be prohibited. Not on safety, not on disease claims, but on an administrative rendering, an opinion, one that—as we’ve seen with NAC—is sometimes arbitrary or capricious.”

And speaking of administrative decisions, Dr. Fabricant told WholeFoods that this bill would let FDA use administrative decisions to deny a product access to market. “FDA reserves the right to determine whether a product is eligible to get on the list or not by rendering it complete or incomplete. This is not only vague, but makes this administrative rather than scientific. If we look at what ‘incomplete’ means for an NDI filing, it means that your product is still in violation of the law. If the agency disagrees with claims or ingredients, do we really think they’ll list the product?”

Dr. Fabricant continued: “Those who support mandatory product listing have gone silent on tough questions regarding how the bill impacts CBD, NAC, etc. It’s clear that the FDA will not take ‘the good, the bad, and the ugly’ and put it on the list. They will reserve the right to call balls and strikes while the industry is left without recourse. Also, why, if there is a need for reform, is this the only reform being discussed when there are a myriad of positive things to address? For instance, a regulatory pathway for CBD, enhanced health claims for things like vitamin D, multivitamins for WIC and SNAP, state pre-emption, the list goes on.”

Related: Dietary Supplement Listing Act of 2022 Introduced; Industry Divided
FDA Issuing Enforcement Discretion Guidance on NAC
The Natural View: Regulatory Update with NPA’s Kyle Turk
Pay Homage to the Past with a Promise for the Future

NPA is working to fight the bill, both by reaching out to key figures in the government and by activating its grassroots network, with forms for contacting representatives here. Dr. Fabricant says NPA isn’t alone: “There are many more people opposing the bill than those in favor. Tens of thousands of emails have been sent to Congress in opposition to the legislation. People don’t want their choices restricted or their costs to increase unnecessarily.”

The full text of the draft can be read here, and a section-by-section breakdown can be read here.

WholeFoods Magazine will continue to share the latest developments, as well as industry perspectives.

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FDA Retracts Warning Letter to Glanbia Performance Nutrition

May 12, 2022 - 8:20am

Silver Spring, MD—On May 9, 2022, the Food and Drug Administration (FDA) announced that it had issued warning letters to 11 companies for selling adulterated dietary supplements. Listed among those 11 companies was Glanbia Performance Nutrition (Manufacturing) Inc., but in an updated announcement posted by FDA on May 10, 2022, Glanbia was no longer on the list.  Now, FDA has formally retracted its warning letter to Glanbia.

In an update posted on May 11, 2022, FDA stated:

“On May 9, 2022, the FDA issued a Constituent Update (below) stating that Glanbia Performance Nutrition (Manufacturing), Inc. (Glanbia), along with 10 other companies, was illegally selling adulterated dietary supplements. However, the FDA has since determined that Glanbia was incorrectly identified and does not sell the products Uplift Max and Shred Her Max, which were cited in the FDA Warning Letter sent to the company on May 4, 2022.

“The error occurred because the website on which the products Uplift Max and Shred Her Max are sold incorrectly stated that the site was the property of one of Glanbia’s subsidiaries, Optimum Nutrition.

“Glanbia discovered this error and immediately notified the FDA. As a result, the Warning Letter the FDA issued to Glanbia has been retracted and the FDA is continuing its investigation to determine the responsible firm and reissue the warning letter.  

“The FDA regrets the confusion this error has caused.”

Find information on letters sent to the other 10 companies here.

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NOW Testing of CoQ10, Quercetin in Brands Sold on Amazon Reveals “Deceptive Labeling Tricks”

May 11, 2022 - 6:31am

Bloomingdale, IL—In 2017, NOW spearheaded an industry self-policing program of testing unfamiliar brands found on Amazon. Using both internal and external labs including Eurofins, researchers compare results to the packaging claims on supplement and vitamin bottles. NOW has previously tested ALA, phosphatidyl serine, CoQ10, SAMe, and curcumin. In the most recent round of testing, NOW uncovered brands featured on Amazon with misrepresented ingredients and dosages for Coenzyme Q10 (CoQ10) and quercetin.

Testing showed that seven out of eight brands had under 30% potency, despite labeling claims. Additionally, three of the eight brands evaluated were labeled as vegetarian, but contained gelatin. 

Still Failing on CoQ10:

In 2020, NOW tested CoQ10 brands and found several mislabeled. In 2022, the company reexamined eight brands of CoQ10 to see if those that were identified as low potency in the prior testing done had improved. The result: “Serious problems” remain for seven out of eight brands tested. NOW also noted that brands are “cheating by misrepresenting potencies through deceptive labeling tricks.”   

Products were tested from three samples of each and tested by HPLC. Findings revealed a manufacturer is likely to be supplying various companies with the same counterfeit products. What NOW uncovered, as outlined in a press release:

  • Clear Formulas, aSquared, Foxy Doc, and Healthy Way brands all mislabel their product as “400mg/6%” potency.  Per NOW: “This is deceptive when the front panel says ‘400mg’ potency and the Amazon title says ‘CoQ10 400mg Max Strength.’  The customer gets less than 24mg CoQ10 per capsule.” 
  • A variety of CoQ10 brands on Amazon were tested by NOW in 2017, 2018 and 2020 with similar failing results. NOW reported that aSquared, Healthy Way, NasaBe’Ahava and We Like Vitamins were all under 35% potency in 2020 as well. 
  • “Perhaps most alarming,” NOW reported, “three of the eight brands claimed to be in vegetarian capsules, but testing both at NOW and at Eurofins confirmed gelatin was used. The failing brands are Clear Formulas, Healthy Way and Sundhed.” 
Quercetin Results:

NOW chose to test quercetin due to the increased demand seen during the COVID-19 pandemic, when raw material costs climbed. Per the release: “NOW felt that if brands were to cheat with potency, a product like Quercetin might be more likely to include less Quercetin than is on the label.  Additionally, Quercetin dihydrate 95% is the raw ingredient used in supplements and some brands claim ‘400mg Quercetin,’ while others may claim ‘420mg Quercetin dihydrate’ and the potency is identical. Some brands label as ‘Quercetin dihydrate’ to show a higher label claim, although this is not normal.”

A look at what NOW found:  

    • Two brand labels Quercetin by stating “18% potency,” which NOW said is the same deceptive trick seen with CoQ10. 
    • NasaBe’Ahava brand “is a repeat violator,” NOW said, labeling Quercetin as “Each capsule contains 500mg Quercetin Dihydrate (20% potency).” 
    • Cadane brand mislabels as 100mg Quercetin 10:1 extract, equivalent to 1000mg, but testing showed it to be “one of the very worst for potency results with only 4% of claim.” 
    • 20 out of 24 brands tested below 90% label potency.
    • 14 out of 24 brands tested with less than 50% of labeled potency. 
    • 2 out of 24 brands tested (Doublewood Supplements and NasaBe’Ahava) used lower cost gelatin capsules when the labels declared vegetarian/cellulose. 

     

In conclusion: “NOW has reported these findings to Amazon directly, as we did previously, but the problem products continue to be sold, and often as a ‘Sponsored’ (paid marketing) featured products,” said Dan Richard, NOW’s Vice President of Global Sales and Marketing. “NOW plans to send a copy of this report to Amazon, NPA trade group, FDA, and FTC. Low-potency brands do harm to consumers everywhere, as well as to honest businesses that make and sell quality products.”

Related: NOW Continues Amazon Tests with Glutathione
Testing Conducted by NOW Raises “Profound Concerns” About ALA on Amazon
NOW Finds “Alarming” Problems With Amazon Phosphatidyl Serine Products

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FDA Warns 11 Companies on Adulterated Dietary Supplements

May 10, 2022 - 6:42am

Silver Spring, MD—The Food and Drug Administration (FDA) has issued warning letters to 11 companies for selling adulterated dietary supplements. FDA reported that letters are being sent for various reasons, including:

  • Some of the supplements contain new dietary ingredients (NDIs) for which the agency has not received the required premarket NDI notifications.
  • Some of the supplements also are drugs, despite lacking approval, because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Under the Federal Food, Drug, and Cosmetic Act, products intended to diagnose, cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements, and generally require preapproval from the FDA.
  • Some of the supplements are being flagged for unsafe food additives.

Warning letters were sent to:

FDA reported that supplements sold by the companies listed above contain one or more of the following:

  • 5-alpha-hydroxy-laxogenin
  • higenamine
  • higenamine HCl
  • hordenine
  • hordenine HCl
  • octopamine.

FDA noted that it has raised concerns about several of these ingredients, and pointed to potential adverse effects of higenamine on the cardiovascular system.

The agency added that is as not evaluated whether the unapproved products subject to this latest round of warning letters are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.

Warned companies have 15 working days to tell FDA how these issues will be addressed, or to provide reasoning and supporting information detailing why the products are not in violation of the law. Failure to adequately address this matter may result in legal action, including product seizure and/or injunction.

This latest round of warnings, which were sent on May 9, come just days after FDA sent warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Those letters mark the first time warnings have been issued for products containing delta-8 THC, which FDA said has psychoactive and intoxicating effects and may be dangerous to consumers.

Related: FDA Sends Warning Letters to CBD, Delta-8 THC Companies
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FDA Sends Warning Letters to CBD, Delta-8 THC Companies

May 4, 2022 - 7:48am

Washington, D.C.—The U.S. Food and Drug Administration (FDA) announced that it has issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA said this is the first time warning letters have been issued for products containing delta-8 THC, which FDA said has psychoactive and intoxicating effects and may be dangerous to consumers.

FDA recently published a consumer update outlining its concerns regarding potential health effects of delta-8 THC products. The agency reported that it has received adverse event reports involving products containing delta-8 THC from consumers, healthcare practitioners, and law enforcement, some of which resulted in the need for medical treatment. The agency also noted that the national poison control centers is receiving increasing number of exposure cases involving products containing delta-8 THC, and that alerts issued by state poison control centers have increased.

Delta-8 THC (one of over 100 cannabinoids produced in the Cannabis sativa L. plant) is not found naturally in significant amounts, FDA stated, and concentrated amounts seen in products such as gummies and vape cartridges are typically manufactured from hemp-derived cannabidiol (CBD).

There are no FDA-approved drugs containing delta-8 THC, the agency explained, and any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug that has not been evaluated by the agency to determine effectiveness for the uses manufacturers claim, nor for appropriate dose, potential interactions, or dangerous side effects and safety concerns.

The warning letters address the illegal marketing of unapproved delta-8 THC products and cite violations related to drug misbranding (e.g., the products lack adequate directions for use) and the addition of delta-8 THC in foods, including those that may appeal to children, such as gummies, chocolate, caramels, chewing gum, and peanut brittle.

Related: FDA Shares “5 Things to Know” about Delta-8 THC
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“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide,” said FDA Principal Deputy Commissioner Janet Woodcock, M.D. “These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety. It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”

Violations noted in the letters include:

  • marketing CBD products claiming to treat medical conditions in humans and animals
  • promoting CBD products as dietary supplements
  • adding CBD to human and animal foods. FDA explained that CBD and delta-8 THC are unapproved food additives for use in any human or animal food product, and the agency is not aware of any basis to conclude that the substances are generally recognized as safe (GRAS) or otherwise exempt from food additive requirements.

Warning letters were issued to: ATLRx Inc., BioMD Plus LLC, Delta 8 Hemp, Kingdom Harvest LLC, and M Six Labs Inc. The FDA has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.

Related:  Dietary Supplement Listing Act of 2022 Introduced; Industry Divided
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FDA Warns 2 Companies for Misbranding Pain Relief Products Containing CBD

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Study: Climate Change Could Spark Next Pandemic

May 2, 2022 - 1:01pm

Washington, D.C.— Researchers who led a comprehensive study published in Nature determined that animal migration and rising temperatures may cause virus spread to new areas, potentially to humans. The study suggests that the climate crisis had an impact on human health, and the greatest risk factor for another pandemic is climate change. It surpassed factors like deforestation, agriculture, and wildlife trade.

The international team of researchers, led by scientists at Georgetown University, found that climate change-related animal migration was linked to Ebola and coronaviruses. They noted that viruses will be harder to track with the infection of new species in greater locations. This will cause higher rates of human exposure. Additionally, thousands of viruses will be shared among wild animals.

“The closest analogy is actually the risks we see in the wildlife trade,” said lead author Colin Carlson, Ph.D., an assistant research professor at the Center for Global Health Science and Security. “We worry about markets because bringing unhealthy animals together in unnatural combinations creates opportunities for this stepwise process of emergence—like how SARS jumped from bats to civets, then civets to people. But markets aren’t special anymore; in a changing climate, that kind of process will be the reality in nature just about everywhere.”

Animal ecosystem migration to human locations will create virus hotspots. This has already begun, with temperatures 1.2 degrees warmer world-wide. Data reflected rising temperatures’ impact on bats, whose travel capacities allow greater spread. One predicted hotspot included Southeast Asia, for this reason.

“At every step,” said Dr. Carlson, “our simulations have taken us by surprise. We’ve spent years double-checking those results, with different data and different assumptions. The models always lead us to these conclusions. It’s a really stunning example of just how well we can, actually, predict the future if we try.”

The impact of climate change on human health could be significant, as viruses transfer at new rates. “This mechanism adds yet another layer to how climate change will threaten human and animal health,” said co-lead study author, Gregory Albery, Ph.D., a postdoctoral fellow in the Department of Biology. “It’s unclear exactly how these new viruses might affect the species involved. It’s likely that many of them will translate to new conservation risks and fuel the emergence of novel outbreaks in humans.”

A possible solution: further research on species infected and their migration patterns. “When a Brazilian free-tailed bat makes it all the way to Appalachia, we should be invested in knowing what viruses are tagging along,” said Dr. Carlson. “Trying to spot these host jumps in real-time is the only way we’ll be able to prevent this process from leading to more spillovers and more pandemics.”

Related: Naturally Informed: Climate Change, Pandemics & Public Health—A Call to Action
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Overall, researchers believe this study will help mitigation efforts and lead to greater understanding of pandemic prevention. Dr. Carlson said, “We’re closer to predicting and preventing the next pandemic than ever. This is a big step towards prediction—now we have to start working on the harder half of the problem.”

In conclusion: “The COVID-19 pandemic, and the previous spread of SARS, Ebola, and Zika, show how a virus jumping from animals to humans can have massive effects,” said Sam Scheiner, a program director with the U.S. National Science Foundation, which funded the research. “To predict their jump to humans, we need to know about their spread among other animals. This research shows how animal movements and interactions due to a warming climate might increase the number of viruses jumping between species.”

 

 

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NPA Alerts DHS, HHS & DOJ to Concerns with Dietary Supplement Listing Act of 2022

May 2, 2022 - 9:46am

Washington, D.C.—On April 26, 2022, Senators Richard Durbin (D-IL) and Mike Braun (R-IN) introduced the Dietary Supplement Listing Act of 2022 with the intent of establishing a requirement for mandatory product listing (MPL) for all dietary supplements marketed in the United States. The Natural Products Association (NPA) expressed deep concerns with the legislation, and is taking quick action against it. As Dr. Daniel Fabricant, NPA President, and CEO, explained, “The FDA already has access to information regarding who is making dietary supplements, what products are made at which facilities, when new ingredients are introduced into commerce, and whether any products are associated with serious adverse events. The Durbin-Braun approach will hurt consumers and needlessly damage the industry.”

NPA called for industry engagement: “NPA has activated its industry-leading grassroots operation to elevate our concerns. Still, we also strongly encourage our friends in the industry to join our growing movement and to convince elected officials that this is the wrong path at exactly the wrong time.”

To combat the legislation, NPA has written letters stating its opposition to Senators Durbin and Braun as well as to the U.S. Department of Homeland Security, the U.S. Department of Health & Human Services and the U.S. Department of Justice. It the letter to Attorney General Merrick Garland, Secretary Of Homeland Security Alejandro Mayorkas, and Secretary of the U.S. Department of Health & Human Services Xavier Becerra, NPA noted “grave concerns” with information that dietary supplement manufactures would be required to provide under the bill. NPA noted that the required information is “precisely the type of information that bioterrorists would need to introduce contaminants or poisons into the food supply, and it would be available to them in a publicly accessible database maintained by the federal government at taxpayer expense.

Related: Dietary Supplement Listing Act of 2022 Introduced; Industry Divided
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