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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Life After Manitoba Harvest: Mike Fata Celebrates 25 Years of a Personal and Entrepreneurial Journey to Health
This article originally appeared on LetsTalkHemp.com
By Steven Hoffman
Mike Fata, founder and former Chair and CEO of Manitoba Harvest – and one of the original founders of the hemp food industry – is celebrating the 25th anniversary this month marking the beginning of his personal journey to health.
In 1995, Mike was, as he said, “an unhealthy and unhappy 18 year old who weighed 300 pounds. I became sick and tired of being sick and tired, and decided to do something about it.”
Along the way, Mike learned a lot about nutrition, a healthy diet and an active lifestyle. He lost 125 pounds, regained his health, and … “the journey to health got me to see the value of hemp seed,” he said.
Inspired by the superfood potential hidden in the hemp seed, Fata in 1998 founded Manitoba Harvest. Today, the award-winning company is a widely recognized global hemp food leader, with lifetime sales in 2020 surpassing $500 million.
After successfully selling Manitoba Harvest in 2019 to Tilray (NASDAQ:TLRY), a publicly traded, vertically integrated cannabis company based in Canada, for US$318 million, Mike is no longer involved on a day to day basis with the company. “It came to the point where the business was going that it was best to have a classically trained CEO leading the company,” he observed.
Yet, having carved out a significant entrepreneurial legacy in hemp and the natural and organic foods industry, Mike has future plans to mentor and invest in companies and brands that are committed to improving health, the environment and the quality of people’s lives.
“My passion is health and my purpose is to share it with the world,” Fata said. “I’m starting to diversify and help other founders fulfill their mission in the natural products space. I’ve made a couple of investments and got involved on the board level, and am involved actively in a couple of businesses.” Mike cites, for example that he’s become involved with Om Organic Mushrooms, an emerging natural supplements brand.
Mike also is committed to helping the hemp industry and natural products industry grow in Canada. “Giving back has been a big part of my work for my whole career; I’ve done 25 years of nonprofit board work,” he shared. Currently, Fata serves as Chair of the Canadian Health Food Association (CHFA), and during his tenure, the organization has been supportive of removing restrictions on CBD sales in Canada.
Currently, there are no legal means to bring non-prescription CBD health products to the Canadian marketplace, said CHFA in a statement. However, the association this past month released a report identifying CBD products as an opportunity for economic recovery in Canada that could create a niche market valued at more than C$1 billion.
“CHFA has been very outspoken in favor of hemp and CBD in the last couple of years,” said Fata. “Currently, to buy CBD in Canada you have to go to a licensed dispensary. We’re trying to change it so natural food retailers in Canada can sell these products.”
In applying what he’s learned leading the growth of Manitoba Harvest, Fata said, “At the end of the day, if you have a great product and you put the right capital and great people together, good things can happen. However, he noted, “The hemp industry is missing strong strategy and planning because it’s still a new industry. Also, more innovation has to happen,” he advised.
Fata also believes that “extracts aren’t the cure all and end all for the hemp industry. People rushed in; it will take years to work out.”
However, Mike notes that there is huge potential for hemp food and hemp fiber. “There is tremendous value in the seed and the fiber 10 to 20 times over where the industry is now,” he said. “For now, we have hemp hearts, but we need more innovation. Look at the advancements in soy protein, pea protein, for example. “Hemp is just scratching the surface. We’re just getting started on being a superfood.”
While Mike admits he is currently under a noncompete agreement in the hemp market as a result of the sale of Manitoba Harvest to Tilray, “I am a super hemp consumer and am super passionate about it, from genetics to market. So, stay tuned.”
The best way to reach out to Mike Fata is via LinkedIn.