Nutrition Industry Up in Arms Over Proposed Dietary Supplements Listing Bill; Could it Be a Slippery Slope to FDA “Preapproval?”
This article originally appeared in Presence Marketing’s June 2022 Industry Newsletter.
“We fully trust FDA will make mischief. We don’t know how, but we do have 60 years of history of FDA authority trying to limit access to supplements.” – Michael McGuffin, President, American Herbal Products Association, in response to S. 4090, the Dietary Supplement Listing Act of 2022
By Steven Hoffman
On April 26, 2022, U.S. Senate Majority Whip Dick Durbin (D-IL), introduced a bipartisan bill co-sponsored by Sen. Mike Braun (R-IN), S. 4090, the Dietary Supplement Listing Act of 2022.
The proposed legislation, according to a statement from Durbin’s office, would require dietary supplement manufacturers to list their products with the U.S. Food and Drug Administration (FDA), known as a mandatory product listing (MPL). In addition, companies would be required to “provide FDA with vital information about their products, including product names, a list of all ingredients, an electronic copy of the label, allergen statements, health and structure/function claims, and more. This information would then be made available to the public,” Durbin’s office said.
Introducing the bill, Durbin said, “70% of people in America take a dietary supplement, including me. I also believe that Americans who take vitamins, minerals, and herbs for their health and wellbeing have a right to know what’s in those supplements. Many people assume that if a product is sold in the United States of America, somebody has inspected it and it must be safe. Unfortunately, that’s not always true.”
Reaction to the bill among industry leaders and associations has been mixed, yet many in the nutrition industry are up in arms in that the bill proposes that all dietary supplements sold in the U.S. be listed in a federal database or registry. Opponents are concerned that it may infer that the FDA would end up gaining “pre-market approval” authority over dietary supplements, in that the bill states that upon receiving a company’s listing submission, FDA will “confirm” a “complete listing” and issue an identification number.
According to Nutritional Outlook, the questions dietary supplements companies are asking include: “What could cause FDA not to confirm a listing? Can products automatically go to market after submitting a listing, regardless of FDA’s response? Could FDA, in fact, use mandatory product listing as a premarket-approval lever to keep certain ingredients off the market?”
“This is purely premarket approval and anyone who tells you different is lying,” Daniel Fabricant , Ph.D., President and CEO of the Natural Products Association (NPA), told Nutritional Outlook. Based in Washington, D.C., NPA opposes the bill and has been galvanizing the dietary supplements industry to act quickly to send letters to voice their concerns to their legislators via a web page here.
“Senators Durbin and Braun are one step closer to creating pre-market approval for dietary supplements a reality. Their bill was recently tied to the FDA Safety and Landmark Advancement Act (FDASLA), creating new regulatory barriers and giving the FDA new authority to prevent health and wellness products from reaching millions of consumers. Sadly, Senators Braun and Durbin are using their dislike of the dietary supplement industry to misrepresent its excellent safety record. The FDASLA is intended for drugs, not supplements, and we cannot afford to allow critics to stifle the industry,” Fabricant said in an appeal to members.
NPA asserts that responsible natural products retailers and manufacturers already go to great lengths to ensure consumers have access to safe products. Operating under the framework of DSHEA, the Dietary Supplements Health and Education Act of 1994, “FDA has a robust regulatory framework to understand what dietary supplements are being sold and who is selling them,” NPA said.
“The FDA has several tools at its disposal, with associated penalties for failure to comply. Retailers and manufacturers also have strong market incentives to make safe products. The proposed language in the Dietary Supplement Listing Act of 2022 requires pre-market approval for dietary supplements, thus is more stringent than the NDI (New Dietary Ingredients) provision, which is a notification. The FDA already has access to information regarding who is making dietary supplements, where they are making 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,” the association added.
In a recent meeting of the U.S. Hemp Roundtable (USHR), representing CBD supplement companies, Michael McGuffin, President of the American Herbal Products Association (AHPA), said, “We oppose the bill because it is redundant, and we don’t think it is so perfectly written that it doesn’t drift into preapproval. I don’t see this as certain pre-market approval, but it says that FDA will confirm a submission that is complete, so what does ‘complete’ mean? FDA will interpret this as it sees fit. For example, you’re required to list all your claims, but they could say you didn’t list all your claims.”
One thing is certain, McGuffin said. “We fully trust FDA will make mischief. We don’t know how, but we do have 60 years of history of FDA authority trying to limit access to supplements,” he cautioned.
McGuffin added, “We like the word ‘listing’ vs. ‘registry,’ which sounds stronger, but Sen. Durbin said specifically ‘registration.’ Even though we all say listing because we agree not to whip people up over this, but the guy who wrote the bill, Sen. Durbin, said registration, Also, there is no exemption for retailers, so every white label brand also will have to register,” he noted.
“We understand there may be an inevitability here, and then we would switch our focus to how to make it least impactful,” McGuffin said, referring to the proposed legislation. “The details are going to be important, and there is a lot we don’t know in this bill.”
Megan Olsen, Senior VP and General Counsel for the Council for Responsible Nutrition (CRN), told USHR attendees that CRN supports the proposed Dietary Supplement Listing Act. Referring to a product registry, she said, “This could give consumers and retailers a place to look to see if products are legitimate, continuing to ensure that there is transparency over the industry and enhancing consumer trust. However,” she added,” our position is that it cannot be pre-approval. If it looks like it’s going that way, that’s when we would push back very strongly.”
In speaking of the proposed dietary supplements legislation, Karen Farrell, Senior Director of Brand Management, Nutrition and Body Care for Presence Marketing, said, “I feel like the industry should keep its antennas high on this one. We already have existing policy in DSHEA; if something needs to be changed, it should be done under the existing structure of DSHEA rather than write separate legislation outside of what already exists. We still have some people who say the supplement industry is unregulated, and that’s just not true,” she said, adding that the proposed bill could also slow product innovation and launch times.
“Dietary supplement manufacturers are already playing by the rules; they are jumping through all the regulatory hoops and have made a commitment to quality. I’ve been reviewing new products and brands for 10 years at Presence, and I think I only ever saw one brand that I had questions about, and we addressed it right away. FDA already has authority to regulate and send warning letters, etc. I don’t think we need this bill; DSHEA works, Farrell added.
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Nootropics: An Emerging Trend in Cognitive Nutrition and Brain Performance
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This article originally appeared in Presence Marketing’s October 2021 Industry Newsletter
By Steve Hoffman
From young students, tech professionals, writers and others looking to enhance brain performance, focus and productivity to aging individuals seeking to boost cognitive health, nootropics is emerging as a significant category in dietary supplements. While consumers may not be familiar with the term itself, they are increasingly turning to nootropic products to help with learning, concentration, remembering, recalling information, gaining new skills, alertness, focus and other activities that require cognitive and mental function, says leading natural products market research firm SPINS in its recent The State of Natural report.
Nootropics (sometimes referred to as “smart drugs”) is a catch-all term for products that are reported to enhance brain and cognitive performance, from food and nutritional ingredients to dietary supplement formulations and even some prescription drugs. Taking gingko biloba or even drinking a caffeinated beverage are examples of taking a nootropic to boost memory or enhance alertness and focus.
According to SPINS, sales of functional nootropic ingredients including bacopa, phosphatidyl serine and DMAE all grew over 100% over the 24 weeks ending June 13, 2021. Other nootropic nutritional ingredients seeing sales growth include GABA, L-Theanine, Acetyl L Carnitine, gingko biloba, DHA, medicinal mushrooms, and more.
“A lot of companies are turning to a blend of different nootropic ingredients for a synergistic effect on cognitive health,” noted Scott Dicker, Marketing Data Analyst for SPINS. SPINS also advises retailers that educating yourself and customers is essential. Shoppers may understand what cognitive health is, but educating them and helping them become aware of the wide variety of supplements, foods and beverages that support brain function and cognitive health will help determine their in-store experience, and purchasing decisions, said SPINS.
As of July 21, 2021, “mental complex” supplements experienced a 58% year-over-year growth rate on Amazon, according to ClearCut Analytics in a report in Whole Foods Magazine. Sales have been steadily increasing for these type of supplements since August 2019, and ClearCut Analytics noted that trends often emerge on Amazon before reaching Food/Drug/Mass (FDM). Formulations in capsules are leading sales of mental complex supplements – capsules hold a 71% market share on Amazon, ClearCut Analytics reports.
Today’s aging population is helping drive sales of nootropics by focusing increasingly on brain and mental health, said ClearCut Analytics. SPINS also noted the COVID-19 pandemic has increased overall consumer interest in products for cognitive health.
Legislation Would Legalize Sale of Hemp-derived CBD Once and For All in Dietary Supplements
This article originally appeared on LetsTalkHemp.com.
By Steven Hoffman
As Americans readied for a long Labor Day Weekend, two members of Congress on September 3 introduced a bill in the U.S. House of Representatives to “make hemp, cannabidiol derived from hemp, and any other ingredient derived from hemp lawful for use under the Federal Food, Drug and Cosmetic Act as a dietary ingredient in a dietary supplement, and for other purposes.”
The Bill, HR 8179, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020, if passed, would allow hemp-derived CBD and other hemp-derived ingredients to be legally marketed as an ingredient in dietary supplements, as long as the products comply with current legal requirements for new dietary ingredients, as well as other requirements pertaining to dietary supplements under federal law.
The bipartisan legislation, introduced in the U.S. House of Representatives by Rep. Kurt Schrader (D-OR) and Rep. Morgan Griffith (R-VA), would direct the U.S. Food and Drug Administration (FDA) to use its authority and resources to set a clear regulatory framework for hemp and hemp-derived CBD and assure consumer protection for these products, reported the American Herbal Products Association (AHPA) in a release.
For marketers of hemp-based CBD in dietary supplements, the bill would eliminate regulatory hurdles and uncertainty that have hampered the category’s growth.
“The Schrader/Griffith bill would ensure that hemp-derived CBD, and other non-intoxicating hemp ingredients, could be lawfully marketed as dietary supplements,” said the U.S. Hemp Roundtable in a statement. “The bill would require CBD and hemp extract product manufacturers to comply with the entire existing comprehensive regulatory framework for dietary supplements, which ensures that the products are deemed safe, properly labeled, and prepared utilizing Good Manufacturing Practices. Passage would also help stabilize the hemp markets, open up a promising economic opportunity for U.S. agriculture and honor our commitment made to farmers in the 2018 Farm Bill.”
Bill co-sponsor Rep. Morgan Griffith added, “Hemp was historically an important crop for Virginia farmers, and dietary supplements made from it do not possess dangerous addictive qualities. Nevertheless, the current state of regulation creates confusion about its legal uses. I joined this bipartisan bill to provide certainty for hemp farmers that their crop may find legal uses,” said Rep. Griffith in a statement.
In response to the proposed legislation, four leading dietary supplement industry associations, including AHPA, the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA), applauded a bill that would protect public health by providing legal clarity in the cannabidiol/CBD marketplace.
“A growing number of Americans view hemp and hemp derived CBD as a way to improve health and wellbeing, driving high consumer demand and a proliferation of CBD-containing products in the marketplace. While the 2018 Farm Bill changed the law to allow hemp farming, regulatory uncertainty remains about the inclusion of hemp and hemp-derived CBD in dietary supplements. This lack of regulatory clarity along with insufficient oversight around hemp and hemp-derived CBD exposes consumers to potentially unsafe products and lack of consistency in product quality,” said AHPA in a September 4 release.
“A legal hemp and hemp-derived CBD pathway would also provide much needed certainty to hemp farmers,” AHPA added. “The dietary supplement industry is proud to support the Hemp and Hemp-derived CBD Consumer Protection and Market Stabilization Act of 2020 and we urge Congress to consider including the bill in a legislative vehicle soon.”
AHPA, CHPA, CRN, UNPA, along with the U.S. Hemp Roundtable, sent lawmakers a letter expressing unified support for the legislation, AHPA reported.
The parent company of Let’s Talk Hemp Media, We Are for Better Alternatives (WAFBA), signed on as an Endorser of the bill.
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Mass Market Sales of Hemp-derived CBD Predicted to Rise Significantly
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Originally Appeared in Presence Marketing News, February 2020
By Steven Hoffman
Look out, specialty CBD retailers, the mass market is coming on. According to a survey conducted by Nutrition Business Journal, CBD supplements and beauty products are now sold in more channels than perhaps any other product in “the history of human commerce,” including natural food stores, pharmacies, supermarkets, doctor’s offices, coffee shops, bookstores, boutiques, fitness clubs, smoke shops, dispensaries, convenience stores and gas stations. Consumer awareness of CBD increased from 47% in 2018 to 70% in 2019, according to NBJ’s survey, and product sales continue to grow at a rapid pace. “The largest shift between 2018 and 2020 is projected to happen in mass market retail, increasing from under 1% of the market in 2018 to almost a quarter of sales in 2020,” says NBJ, which attributes much of that growth to the sales of topical hemp-derived CBD products. However, NBJ predicts that mass market channels will continue to see success in CBD sales as more stores offer dietary supplement product options. NBJ estimates that sales of hemp-based CBD products will reach $4 billion by 2023.
New Bill Would Require FDA to Allow Marketing of CBD in Dietary Supplements
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Originally Appeared in Presence Marketing News, February 2020
By Steven Hoffman
A bill introduced in the U.S. House of Representatives would allow hemp-derived CBD to be marketed in dietary supplements and food products. Introduced by Collin Peterson (D-MN), Chair of the House Agriculture Committee, the bill would explicitly include hemp-derived CBD in the definition of a dietary supplement, reports New Hope Network. The bill is important, reports Marijuana Moment, because, while hemp and its derivatives were federally legalized under the 2018 Farm Bill, according to former FDA Commissioner Scott Gottlieb, it could take years for the FDA to finalize rules around allowing hemp-derived cannabidiol (CBD) in dietary supplements and food products—unless Congress steps in, he said. The legislation, filed on January 14, 2020, if passed would amend the Federal Food, Drug and Cosmetics Act to include CBD in the definition of dietary supplements. “The last two Farm Bills were landmark successes for hemp, but we are still very early in this process, and growers need regulatory certainty. This bill will allow FDA to regulate CBD that comes from hemp as a dietary supplement, providing a pathway forward for hemp-derived products. It would also identify barriers to success for hemp farmers, informing growers and policy makers of the challenges facing this new industry,” said Congressman Peterson in a statement. Learn more about current FDA, USDA, and state-level hemp and CBD policy and regulation at the upcoming 7th Annual NoCo Hemp Expo, the world’s largest exposition, conference and gathering of hemp industry professionals, March 26-28, 2020, at the National Western Complex in Denver, CO.
FDA Announces Plans to Tighten Oversight of Dietary Supplements; Issues Warnings to 17 Companies
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For Presence Marketing Newsletter, March 2019
By Steven Hoffman
In what Food and Drug Administration (FDA) Commissioner Scott Gottlieb called “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years,” FDA on February 11 announces plans to strengthen its oversight of the dietary supplements market.
“In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA’s authority to regulate dietary supplements, the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers,” Gottlieb said in a statement.
According to FDA, the use of dietary supplements, such as vitamins, minerals or herbs, “has become a routine part of the American lifestyle.” Three out of every four American consumers take a dietary supplement on a regular basis. For older Americans, the rate rises to four in five. And one in three children take supplements, either given to them by their parents or, commonly as teenagers, taking them on their own, the agency said.
Commissioner Gottlieb’s statement acknowledged the widespread use of supplements and also that “most players in this industry act responsibly” under the regulatory framework that exists under current law. He also said, however, that “bad actors” have been able to “exploit the halo” created by good companies, and so have been able to distribute and sell potentially dangerous products that put consumers at risk.
“As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver,” Gottlieb said.
Under the new policy, FDA is developing a “rapid-response tool” to alert the public to avoid buying products that may contain unlawful or potentially dangerous ingredients. The agency also is looking to update its compliance policies with new dietary ingredient notifications (NDIs), which requires manufacturers to alert the FDA of any ingredients that weren’t sold in the U.S. before 1994.
“An effective NDI notification process represents the FDA’s only opportunity to evaluate the safety of a new ingredient before it becomes available to consumers and helps promote transparency and risk-based allocation of resources,” Gottlieb said.
FDA also is creating the Botanical Safety Consortium, a partnership between the public and private sectors, to evaluate the safety of botanical ingredients and mixtures in supplements.
“As we celebrate in 2019 the 25th anniversary of the passage of DSHEA, AHPA shares Commissioner Gottlieb’s vision…of finding the right balance between preserving consumers’ access to lawful supplements, while also protecting the public from unsafe and unlawful products and holding accountable companies that are not in compliance with the law,” Michael McGuffin, President of the American Herbal Products Association (AHPA), said in a statement. “AHPA has previously communicated specific suggestions for regulatory improvements to FDA and we look forward to a robust and transparent discussion on how best to serve Americans who include supplement products in their families’ health care choices,” he said.
Regarding NDIs, McGuffin added, “AHPA has invested significant resources to assist industry in submitting NDI notifications that meet the statutory requirements to bring a new ingredient to market. We have also submitted thoughtful comments to FDA’s prior draft NDI guidance documents and will continue to provide input so that any eventual guidance is both useful to the trade and does not stray from FDA’s statutory authority.”
Under its tightened regulations, FDA also is hoping to make enforcement processes easier, which allows employees to issue warnings to companies and consumers. The agency on February 11 rolled out part of its plan when it sent warning letters to 17 companies for “illegally selling” products that it said claim to treat Alzheimer’s disease.
“I’ve personally benefited from the use of dietary supplements and, as a physician, recognize the benefits of certain supplements as a part of a comprehensive care plan,” Commissioner Gottlieb said. “It’s clear to me that dietary supplements play an important role in our lives as we strive to stay healthy. It’s also clear that the U.S. Food and Drug Administration plays an important role in helping consumers make use of safe, high-quality dietary supplements while also protecting Americans from the potential dangers of products that don’t meet the agency’s standards for marketing.”