The Council for Responsible Nutrition (CRN) plans to travel to Capitol Hill in 2020 to seek sponsors for a bill that would require the FDA to list dietary supplement products, the trade association chief said. in a recent interview.
The FDA is also working on legislative language for congressional consideration, said Steve Mister, president and CEO of CRN. Monsieur noted that an FDA official, Lowell Schiller, discussed the issue at CRN’s annual Dietary Supplement Symposium in November in Carlsbad, California.
In 2020, “We will be on the Hill to start looking for sponsors and co-sponsors of bills for legislation that would create mandatory registration,” Mister said in an interview on Dec. 19. “It is very important that the industry has their own version of what this language would look like so that we are not only able to react to what the FDA might have, but that we actually have a vision of what it is. a compulsory registration bill look like. “
Asked about a deadline at the CRN conference for releasing language on a specific legislative proposal, Schiller said: âWe’re working on something. You will see it soon â, according to the memory of Monsieur.
Schiller’s remarks, Sir said, reinforced “the FDA is working on its own version of the language.”
FDA support for a mandatory product list is common knowledge: the agency proposed such a requirement in its fiscal 2020 budget request to Congress.
“This proposal would require that all products marketed as ‘dietary supplements’ be listed with the FDA and give the FDA the authority to act against non-compliant products and the manufacturers and / or distributors of those products,” he said. explained the agency in its budget request. “This would allow the FDA to know when new products are introduced, to identify and act quickly against dangerous or illegal products, to improve transparency and to promote risk-based regulation.”
Asked about plans to draft legislation for congressional consideration, FDA spokeswoman Lindsay Haake referred to the FDA’s fiscal 2020 budget proposal to require that supplements are listed with the FDA.
“The FDA strongly supports this policy, which would dramatically improve the agency’s ability to effectively and efficiently protect public health, and we look forward to working with Congress and other stakeholders to advance this goal,” a- she added in an email.
Based on annual sales and new products, the supplement industry has exploded over the past 25 years since the passage of the Dietary Supplements Health and Education Act of 1994 (DSHEA). In a 2019 statement, then FDA Commissioner Scott Gottlieb, MD, said that “over 50,000 – and possibly as many as 80,000 or even more – different products” are available under form of food supplements.
But since dietary supplement products are not listed with the government, the FDA has no reliable way of knowing the actual number on the market or tracking them all.
“Today, without a mandatory list of products, we lack basic information about the dietary supplement market,” Schiller, senior associate policy commissioner for the FDA in the Policy Bureau, said in a speech. November 7 at the CRN conference. “We don’t know how many dietary supplements are on the market, and we have no systematic way of knowing when a new product is introduced.”
He added, âWe don’t know how many products contain a given ingredient. And if it turns out that there is a safety issue with a particular ingredient, or a particular ingredient supplier, we don’t have the basic information to quickly identify which products are affected.
Criticisms of the proposal
Factions within the industry are divided over the pros and cons of a mandatory supplement product list. Some support the idea for reasons identified by the FDA, while others claim that the requirement would place another burden on compliant companies while failing to address existing issues, such as “bad actors” putting ingredients. dangerous in their “supplements” or otherwise violate their legal obligations. .
âI see this as unnecessary work,â said Marc Ullman, legal counsel for Rivkin Radler LLP, in an interview. âThe FDA already has access to this information. “
For example, he said the FDA has access to product information when companies making structure / function declarations notify the FDA, as required by law.
âSo now all we’re going to do is create yet another regulatory burden on businesses that file their 30-day notices with no apparent end,â he said.
Daniel Manufacturer, Ph.D., president and CEO of the Natural Products Association (NPA), also questioned the caution of focusing today on creating a mandatory product list through legislation. He said the FDA had not adequately used its existing authority and resources to address issues, such as manufacturers’ failure to file new food ingredient notifications (NDINs) with the FDA.
“If the agency is not going to use the existing statutory authority like on NDI, why are we even talking about additional additions?” asked Manufacturer, previously division director (now Office) of dietary supplement programs. “Let’s see its implementation first, then we can talk about additional additions.”
Manufacturer acknowledged that a list of dietary supplement products could be helpful – “and I use the word” maybe “emphatically” – but stressed that it was premature to have the conversation when the FDA did not ‘failed to maintain one of the pillars of the law: the NDIN requirement.
“It’s about rearranging the lounge chairs on the Titanic to even have the conversation,” concluded Manufacturer, who also spoke to Natural products INSIDER about a list of dietary supplement products in a podcast interview published in December.
Support for mandatory product list
Schiller, the head of the FDA, dismissed concerns that a product list would impose undue burdens on the industry.
“We are not talking about imposing a new pre-market approval requirement,” he said during his speech at the CRN conference. âIf manufacturers and distributors were just to provide us with certain basic information – information that in many cases already appears on product labels – it would be a great victory for public health and the legitimate industry, while imposing only minimal new costs. “
Scott Bass, a lawyer who helped draft the DSHEA, is a strong supporter of a mandatory product list.
“How can the FDA use one of its tools to protect the public or enforce the law if it doesn’t know what is out there?” Bass, a Washington partner with Sidley Austin LLP, asked in an interview. “I mean, it’s just logic.”
Loren Israelsen is president of the United Natural Products Alliance (UNPA) which worked closely with Bass in the negotiations on Capitol Hill leading to the passage of the DSHEA. He also expressed support for a mandatory product list.
“UNPA supports the concept of mandatory product registration,” he said in a statement, “as a logical step to provide a central database to the FDA to know how many products of what type are available. for consumers “.
In an article recently published in the New England Journal of Medicine (NEJM), Bass and Dr Pieter Cohen of Harvard Medical School explained their support for a mandatory product list.
“Mandatory submission of product labels would improve transparency and improve the ability of the FDA to use its authority under the DSHEA to regulate products,” wrote Bass and Cohen. “The agency could be required to provide each product with a unique barcode or quick response code and could use those codes to track adverse reactions, manufacturing issues and adulteration.”
The system would allow the FDA to “determine if a labeled ingredient is new and lacks adequate evidence of safety before a product hits the market,” said Bass and Cohen. “The agency could flag products containing such ingredients in the label database so that retailers can easily confirm that a product has been properly listed with the FDA before making it available in retail stores or in line.”
Ullman, however, asked how the FDA can determine if an ingredient is new based on a list of dietary supplement products with the FDA.
Falsification, erroneous propositions
Enter Robert Durkin, legal counsel to Arnall Golden Gregory LLP and, until recently, deputy director of the FDA’s Office of Dietary Supplement Programs. It supports a mandatory list of products, but erected with “teeth”.
Durkin explained some of the challenges his former employer faces in actively monitoring the supplement market.
“Because there is no pre-market approval as it is a completely post-market paradigm, the FDA has no idea if a product is on the market and adulterated until. ‘she has a reason to know it,’ he said in an interview. “Unfortunately, the reason for knowing that the product hurts someone.”
James Prochnow, partner in Denver at Greenberg Traurig LLP, acknowledged the challenges the FDA faces in identifying new food ingredients in the market.
“There has to be a mechanism for the government to be aware of a new food ingredient that is being introduced to the market, and currently there isn’t,” Prochnow said in an interview.
Durkin proposed that dietary supplement companies that list their products with the FDA answer specific questions, including (among others) whether they have a basis for concluding that an ingredient requires an NDIN from the FDA or not, and whether or not. a manufacturer has submitted an NDIN to the agency or determined an ingredient is GRAS (generally recognized as safe).
Durkin also proposed incorporating provisions into the code of federal regulations that if a product is not properly listed with the FDA, it is adulterated and mislabelled in violation of the law.
“If the FDA has reason to believe or can show that any of its [manufacturersâ] prior attestations were false, the FDA can remove a listing, âDurkin said in an interview, further explaining his proposal. âThe FDA draws up a list: the product is automatically mislabelled and adulterated. It can be grabbed. It can be withdrawn from the trade.
Councilor Todd Harrison shared a similar proposition that if dietary supplement products are not listed with the FDA, they are falsified in law. If a manufacturer did not list any products, all of their products would be considered adulterated according to the advocate’s proposal.
âMandatory product registration and listing only works if it has teeth,â said Harrison, partner of Venable LLP, in an interview. âThere are too many people willing to circumvent the laws. “