Foreign regulations could influence DSHEA reform

Government officials and industry representatives weighing reforms to the Dietary Supplement Health and Education Act of 1994 (DSHEA) may be considering the pros and cons of government frameworks in Canada and around the world.

During a May 16 meeting hosted by FDA related to “responsible innovation in dietary supplements,” officials from Health Canada discussed its regulatory framework governing natural health products.

“It would be arrogant and egocentric to think that the U.S. is the only country in the world that has a regulatory system that means anything,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in an interview. “It’s certainly valuable to look at other countries and see if there are bits and pieces of what they do that might be useful here.”

CRN is a non-governmental organization (NGO) at the Codex Alimentarius Commission (Commission) representing the dietary supplement industry, Mister said. Established by the Food and Agriculture Organization of the United Nations (FAO) and World Health Organization (WHO) to protect the health of consumers and promote fair practices in food trade, the Commission adopts codes, guidelines and standards.

NGOs are among those classified as “observer organizations” that contribute to the standard-setting process at the Commission, according to the agency's website. Just last week, Jim Griffiths, Ph.D., senior vice president of international and scientific affairs with CRN, attended Commission meetings in Geneva, Switzerland, Mister remarked.

Through its participation in Codex, “we’re always talking to international regulators and looking at what other systems are doing,” Mister said. “Many times, it’s for the purpose of exporting the U.S. approach to other countries to make their laws more compatible with ours. But it also gives us a chance to look at what other countries are doing and say, ‘Well gee, is there something here that we could bring back to the U.S.?’”

Health Canada

North of the U.S. is a regulatory model with various distinctions from DSHEA. Health Canada, for example, allows companies to make stronger claims about their natural health products compared to the structure-function claims in the U.S. for dietary supplements, sources familiar with the Canadian regulatory model said. That’s provided marketers in Canada produce strong evidence to support the claims.

Each natural health product must be approved by Health Canada, which then assigns the product a unique Natural Product Number (NPN) and enters the information into its Licensed Natural Health Products Database, Manon Bombardier, Ph.D., a Health Canada official, explained during the May 16 FDA meeting.

Under Canadian law, health officials are seeking to ensure efficacy, quality and safety of natural health products, Bombardier said. 

“So natural health products, including dietary supplements, are subject to requirements, and we want to make sure that they’re safe, they do what they say on … their labels, and they’re manufactured consistently in accordance with the quality standards that apply to them,” she said.

Jim Emme, CEO of NOW Health Group, said his Canadian subsidiary has obtained more than 750 NPN numbers and been “able to make more effective claims.” Among the evidence provided to Health Canada to support claims: historical studies and randomized clinical trials conducted on the ingredients, Emme said.

He described the process as one that “supports consumers and transparency.”

“It may be that there’s some good parts of the Canadian system that we could apply to DSHEA,” Emme said. “Unfortunately, we’d probably have to open up the statute in order to get that done.”

Mister acknowledged an NPN number may give consumers greater confidence in the products. On the other hand, he pointed out Health Canada could reject a claim if it determined the evidence was not sufficient to support it.

“They have the ability to say ‘no,’ which does keep some innovation out of the Canadian market,” said Mister, who also serves as vice chair of the International Alliance of Dietary/Food Supplement Associations (IADSA).

In the U.S., marketers of dietary supplements intending to make structure/function claims must notify FDA. Though the notification process does not require pre-market approval, marketers must possess the evidence to substantiate their advertising and labeling claims.

Commenting on Canada’s licensing system, Mister said, “Looking at those things not only gives us ideas for what will work, but it helps show us what doesn’t work.”

Notification systems

Michelle Stout, regulatory policy director of Amway and chair of IADSA, noted several countries are moving toward a notification system for many of their products.

“Europe is a notification system,” she said. “China just moved some of its products to notification. Pacific Alliance is talking about notification. [And] Brazil who just created regulations for the first time for the food/supplement category is a notification.”

In the U.S., FDA and others have proposed a mandatory listing of dietary supplement products. If passed through legislation, the requirement could enable FDA to respond more quickly if it identifies an unlawful or unsafe product on the market, said Jay Sirois, Ph.D., senior director of regulatory and scientific affairs with the Consumer Healthcare Products Association (CHPA).

“It’s about making sure that the authorities know what’s on the market .. and who the players are on the market,” Stout said. A requirement that products are listed with authorities, she added, “is probably the one thing we don’t have that many other countries do have to bring that transparency.”

Enforcement

Stout suggested authorities around the globe are recognizing the importance of shifting their focus to “post-market surveillance and enforcement.”

For example, during the IADSA annual meeting in Sydney, Australia, the Therapeutic Goods Administration (TGA) discussed its enforcement efforts during random inspections. Though TGA officials identified low compliance, they found well over 60 percent of companies came into compliance after the issues were brought to their attention, Stout observed.

Most reforms in Australia, she explained, have been focused on eliminating regulatory burdens and allocating more time to enforcement. Mister described TGA’s regulatory model as an “interesting” one, but he added, “That doesn’t mean we would adopt their system lock, stock and barrel because it probably wouldn’t fit for the way we view supplements overall.”

Safety comparisons

The requirements in the U.S. to establish the safety of ingredients in dietary supplements are as strong as any other system in the world, Stout opined.

Another prominent industry executive agreed FDA-regulated dietary supplements are safe. 

Guru Ramanathan is senior vice president and chief innovation officer at GNC Holdings Inc. He described as "minimal" the "safety risk for dietary supplements" and "excellent" the product category's "safety record," especially when compared to other categories of products regulated by FDA.

Stout, nonetheless, cited a general challenge facing U.S. distributors and manufacturers: determining under what circumstances they must provide a safety notification to FDA.

“Can I count this as an old dietary ingredient?” she asked. “Do I need to do a notification? Has it really been ‘chemically altered?’”

“That’s where I think clarity would be useful within the U.S.,” Stout said.

FDA in 2016 published a second draft guidance on new dietary ingredient notifications, though it has yet to issue a final document. While in many countries the government and regulated industry have a similar understanding of what’s expected, the FDA guidance did not provide additional clarity, Stout argued.

“I think it’s brought more confusion than before we had the [draft] guidance,” she said.

Overhaul of DSHEA

As DSHEA approaches its 25th-year anniversary in October, FDA and industry leaders are considering changes to the regulatory framework governing dietary supplements, either through FDA’s existing authority or via legislation.

Sirois is among those who believes the law struck the right balance between promoting access to natural products and protecting the public health.

But he and others acknowledged the industry’s tremendous growth over the last quarter century and are open to conversations about modernizing U.S. regulation of dietary supplements. FDA has reported upwards of 80,000 products on the market—20 times the estimated number in 1994.

“The industry’s changed in 25 years,” Sirois said.

Stout advocated FDA increase its enforcement of existing regulations to conduct more cGMP (current Good Manufacturing Practices) inspections and target “bad actors,” such as those that intentionally spike their products with undeclared pharmaceutical ingredients.

But she doesn’t believe it’s time for a major overhaul of DSHEA.

“We’re not having serious safety issues,” Stout said.

Ramanathan reiterated dietary supplements are safe, and he said the legal framework is proper. 

As amended by DSHEA, the Federal, Food, Drug and Cosmetic Act (FD&C) "provides FDA with more than sufficient authority to address the small percentage of products that are unsafe, either because these products are not properly manufactured, contain illegal and unsafe ingredients, or are intentionally spiked with drug ingredients," he said in an email. "In short, if DSHEA is enforced, there is no need to adopt laws from other countries to achieve the goals that DSHEA was intended to achieve and has achieved: access to safe and beneficial products, and protection of public health."

‘Bad actors': a global phenomenon

Finally, Stout said pre-market approval isn’t the answer to weeding out the bad actors, which Sirois characterized as a “small percentage of the industry” that is putting “a black eye on the rest of the folks that are doing it the right way.”

Around the world, “more and more authorities are recognizing that having strict premarket approval review does not stop the bad actors or the noncompliance,” Stout said. “Even the countries that have the strictest registration requirements that take forever—those countries have those bad actors.”