FDA has sufficient authority under the Dietary Supplement Health and Education Act of 1994 (DSHEA) to protect consumers when dangerous ingredients end up in products marketed as dietary supplements, four veteran lawyers said in interviews.
Some of them, however, conceded FDA should take swifter action to protect consumers and leverage its full breadth of enforcement tools, including criminal prosecution.
Although FDA has adequate tools to protect consumers, the agency “appears reluctant to enforce” the law, said Steven Shapiro, of counsel to New York-based Rivkin Radler LLP, who has more than 30 years of experience in food and drug regulatory matters.
For example, he questioned the value of FDA writing a warning letter to a company that has already been put on notice through previous warning letters that a controversial ingredient like DMAA (1,3-dimethylamylamine) does not belong in dietary supplements.
Instead, Shapiro suggested FDA initiate a serious enforcement action—such as a seizure of products or criminal prosecution—against a company putting unsafe ingredients in their products and clearly violating the law.
“Perhaps … there needs to be more of a deterrent against these really bad players,” he stated.
On the other hand, companies devoted to conforming to the rules aren’t going to ignore an FDA warning letter, he noted.
“They will do what’s necessary to correct whatever has to be done,” Shapiro said.
A partner in Washington with Venable LLP, Claudia Lewis started practicing food and drug law in 1995. She maintained FDA has the tools to properly regulate the dietary supplement industry and can “effectively” remove an unsafe ingredient from the market.
“It may take more resources on the agency’s part, or the agency might have to be more forceful in certain areas, but … the law is there for them,” she said.
Adverse events tied to ephedra and other controversial ingredients don’t reflect a failure of DSHEA, said James (“Jim”) Prochnow, a shareholder in Denver with Greenberg Traurig LLP.
Unless the legal framework over dietary supplements is going to require pre-market approval, Prochnow suggested situations will arise in which an ingredient poses a threat to public health. But requiring pre-market approval for dietary supplements, Lewis said, would “stifle innovation and creativity” and undermine the intent of DSHEA.
Prochnow said FDA must act swiftly and exercise its enforcement authority when there is a reasonable probability that a product or ingredient will harm consumers.
He added the agency must have leaders who are willing to exercise the government’s “considerable enforcement power—criminally as well as civilly.”
“That’s the government’s biggest hammer,” Prochnow, who worked for part of the 1970s in the civil division of the U.S. Department of Justice (DOJ) and at the White House, said. “They just have to exercise it.”
Under DSHEA, the government bears the burden of establishing a product is “adulterated” or unsafe. Industry lawyers rejected the idea that the burden of proof unduly hamstrings FDA’s ability to remove dangerous products from the market.
Typically, when the U.S. government goes to court, it is armed with “stellar witnesses” and brings a “strong case” that shifts the burden to the defendant, Prochnow said.
“Even though there’s a technical burden of proof on the government, that burden quickly changes,” he said.
DSHEA incorporates multiple standards in which FDA can demonstrate a dietary supplement is unsafe. For instance, the secretary of the U.S. Department of Human Health and Services (HHS) has authority to declare a supplement poses “an imminent hazard to public health or safety.”
Although HHS has never invoked its emergency power in this manner, it is a “potent” tool the government could use to target a dangerous ingredient, said Scott Bass, a partner in Washington with Sidley Austin LLP who heads the firm’s Global Life Sciences team.
Among other tools, FDA also has authority under DSHEA to target an ingredient subject to a new dietary ingredient notification (NDIN) that failed to provide one, he pointed out.
Beyond FDA enforcement, Prochnow suggested the significant number of class-action lawsuits regularly filed today against dietary supplement companies functions as an incentive for manufacturers to produce safe products. He and his son, Justin Prochnow—also a shareholder in Denver with Greenberg Traurig—regularly review class-action lawsuits that allege false and misleading statements and other violations of law.
The false adverting lawsuits, Jim Prochnow said, educate “the industry about the need to really follow the regulations and produce a safe product.”
In the 1990s, controversy surrounding the marketing of ephedra in dietary supplements highlighted the debate over the adequacy of DSHEA. FDA in 1997 published a proposed rule in which a supplement would be adulterated if it contained 8 mg or more of ephedrine alkaloids per serving. FDA didn’t issue a final rule banning ephedra-containing supplements until February 2004.
Following a two-day meeting in August 1996 that Bass attended, FDA advised the media that its hands were “tied by DSHEA,” the lawyer recalled. By then, Bass added, FDA had received hundreds of serious adverse event reports (AERs) tied to ephedra.
“They used the press to attack the law,” he said.
FDA asked an advisory committee during an August 1996 meeting to assess supplements containing ephedrine alkaloids and make specific recommendations regarding how to address public health concerns surrounding their use, according to a 1997 Federal Register notice.
Bass said the federal government could have taken action at the time against ephedra-containing supplements by, for example, using the HHS secretary’s emerging authority or otherwise establishing in Section 402(f)(1) of DSHEA that dietary supplements containing ephedra were adulterated.
“Nobody knew at that point that the AERs were faulty,” he observed.
Shapiro said FDA gained experience going through the ephedra rulemaking and should be more efficient if it wants to initiate a similar process in the future.
By and large, dietary supplements haven’t had many safety issues, according to some of the lawyers interviewed.
“Considering the limited number of safety issues we’ve had to face over the 25 years since DSHEA was implemented," Lewis said in a follow-up email, the dietary supplement industry is "more safe than not.”
Critics of the industry’s legal framework disagree and cite as examples products marketed as dietary supplements and tainted with undeclared pharmaceutical ingredients. Many of these products are marketed for weight loss, muscle building and sexual enhancement.
“Instead of a law that strengthened FDA’s hand, what we wound up with was a law and subsequent regulations that have weakened” the agency’s authority, said Peter Lurie, M.D., president of the Center for Science in the Public Interest (CSPI), a Washington-based consumer advocacy organization, in an interview.
Lurie, who previously served as FDA’s associate commissioner for public health strategy and analysis, noted FDA took a decade after DSHEA was passed to adopt cGMPs (current good manufacturing practices), and yet many products marketed as supplements aren’t properly manufactured. “The FDA has identified hundreds of products that were tainted by actual prescription drugs,” he said.
One of the chief architects of DSHEA—former Sen. Orrin Hatch (R-Utah)— acknowledged in a recent podcast interview that spiking of products with pharmaceutical ingredients has been “too widespread a problem before and after 1994.”
Hatch said better enforcement of the cGMP audits could address “bad actors” whose products are unintentionally adulterated with drugs. He also supported the creation of an interagency federal task group to target products intentionally spiked with pharmaceutical ingredients.
“Given that it is a problem that spans several agencies,” such as U.S. Customs and Border Protection, DOJ and HHS, “if they’re willing to take it on, I think this would be a good idea,” Hatch said.
Lawyers interviewed for this story also supported the idea of an interagency task force.
Beyond that, Bass reiterated his support for a mandatory dietary supplement product listing that he said would further bolster FDA’s ability to target dangerous products. Such a listing would likely require a change in the law since FDA has said in a budget request to Congress it doesn’t have clear authority to require companies list their dietary supplement products.
A mandatory product listing, Bass said, would enable FDA to effectively target companies that aren’t following DSHEA. For example, he said FDA could identify a registered product that incorporates an NDI but hasn’t provided the agency evidence of safety. He also cited the scenario in which an unregistered product spiked with a pharmaceutical drug is flagged at the border.
A product listing, Bass explained, would give FDA officials “a much better screen to focus their enforcement resources on the products that can be more dangerous.”
Shapiro, however, questioned the purpose of a mandatory product listing “other than to create busywork for legitimate companies” and “draw resources away from real enforcement.”
“What’s the purpose of everybody filing their labels?” he asked. “The noncompliant companies aren’t going to file their labels obviously if they don’t comply with anything else.”
He argued FDA already has the ability to target companies that make statements about their dietary supplements but fail to notify FDA about their structure/function claims despite a requirement in DSHEA to do so.
“Why do we have to create a whole other complicated, costly, time-consuming procedure?” Shapiro asked.
But with an estimated 50,000 to 80,000 dietary supplement products on the market, Bass cited FDA’s challenges in identifying companies that violate the law. He said many companies change their name or business location after receiving a warning letter from government agencies like FDA or FTC, and many products come from overseas.
“There’s no way that any agency could capture most of what’s being sold,” Bass concluded.
Hatch said a product listing “makes sense” to him, but he suggested any requirement adopted by Congress must be “fair” and not overly burdensome “with too much reporting of information that FDA does not have the resources to use.”
“In other words, we should not regulate the dietary supplement industry into the ground, which some people will try to do, acting like they’re the sole protectors of our health … in this country,” the former U.S. senator said.