The dietary supplement industry is populated with unsavory characters who spike their products with undeclared pharmaceutical ingredients like the ones found in products marketed to boost sexual performance.

The notion above is a fallacy that vexes Michael McGuffin, head of the American Herbal Products Association (AHPA).

“These are not dietary supplements,” observed McGuffin, commenting on a recent announcement by FDA officials that a pilot program identified several drug-laden products marketed as supplements for weight loss and sexual performance. “Dietary supplements don’t contain sildenafil [and] sibutramine. Those are drugs.”

McGuffin stressed FDA should differentiate between lawful dietary supplements and ones that purport to be supplements but are, in fact, unapproved drugs.

FDA’s pilot program highlighted a continuing dilemma that threatens to soil the reputation of law-abiding supplement companies in the United States: the presence of undeclared drugs in products coming from overseas. The program focused on dietary supplements marketed for weight loss and sexual enhancement.

Of the approximately 240 samples collected and screened at international mail facilities (IMFs), 65 percent tested positive for undeclared pharmaceutical ingredients. Such tainted products, FDA has said, can adversely interact with prescription medicines and cause harm to consumers.

'These Are Marginal Products'

Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), expressed concern that industry critics would misinterpret FDA’s findings. He distinguished FDA’s pilot program from a theoretical scientific study in which regulators randomly selected 100 products sold on the U.S. market.

“They went into these international mail facilities looking for products that they suspected were going to be problematic, starting with the fact that they were being marketed for sexual enhancement and weight loss,” Mister said. “Weight loss and sexual enhancement is a very small portion of the supplement space, and these products are a very small portion of those categories.”

Added McGuffin: “These are marginal products. If I go through AHPA’s member list and I stack up all the companies that sell male enhancement products with embarrassing names, we’re not selling them.”

Laura MacCleery is policy director with the Center for Science in the Public Interest (CSPI), a consumer watchdog group that closely follows activities in the dietary supplement industry. She was pleased to learn of FDA’s pilot program.

“I think it’s really powerful that FDA is taking a more technologically aggressive approach to looking at what comes into the country and trying to address the problem of tainted supplements,” she said.

While MacCleery supported FDA’s plans to roll out portable screening devices at nine IMFs throughout the United States, she said it was important FDA continue to test supplements sold on the U.S. market to ascertain whether they are spiked with undeclared drugs.

“It’s very troubling the extent to which consumers are defrauded by these kinds of products and by the false marketing claims that they make,” MacCleery said.

American consumers aren’t entirely innocent victims. They may be seeking out drugs, for example, to boost their performance in the gym or bedroom, without having to obtain a prescription from a physician.

“Don’t forget you got a willing consumer,” McGuffin remarked. “You got a consumer who hopes the drug is in there, and that’s what they’re shopping for. And that’s why they’re willing to pay $65 or a $100 a bottle. They hope there’s some sildenafil there.”

Industry Groups Push for Enforcement

Daniel Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), lauded FDA for using new technology to identify adulterants in products masquerading as supplements. He nonetheless echoed the observations of his colleagues that enforcement is equally important, including criminal prosecution.

“I’m glad to see that they’re getting more resources, at least for the testing part, but we both know that’s one piece of the equation,” said Fabricant, who previously led FDA’s Division (now an Office) of Dietary Supplement Programs. “The other piece of the equation is, are there going to be more resources dedicated to the enforcement part?”

McGuffin described the people behind undeclared drug products as “creeps,” and he wants as many of them to go to prison as possible.

If FDA officials are “really serious about this, [they] should be bringing criminal charges against these companies,” Mister said. “They have to get people at the Justice Department to prosecute them. Otherwise, you’re just sending up panic to consumers to say, ‘Oh, these products are not safe,’ and that has the potential to take down all the legitimate products.”

Supplement Executive, Others Criminally Prosecuted

Asked to comment, FDA referenced several criminal cases tied to drugs coming from overseas.

Following a six-day jury trial in 2017, Ismail Ali Khan was convicted of conspiracy, illegal importation of misbranded drug products from China, receiving misbranded drugs that had moved in interstate commerce and making false statements to become a naturalized U.S. citizen.

“Distributing unapproved and misbranded drugs disguised as all-natural supplements places the U.S. public health at risk,” said Justin Green, special agent in charge of FDA’s Office of Criminal Investigations’ Miami Field Office, in a Feb. 16, 2017 press release, announcing Khan’s conviction. “We will remain vigilant in our efforts to protect American consumers from these fraudulent and potentially dangerous products.”

In March 2017, a jury found Sitesh Bansi Patel—the former vice president of a supplement manufacturer, SK Labs—guilty of one count of conspiracy to defraud FDA, one count of conspiracy to commit mail fraud and three counts of mail fraud. According to an FDA news release, a co-conspirator, Guillermo “Willy” Ramos, obtained his raw powder for products containing designer drugs from a Chinese national who forfeited US$1.6 million and served five months in prison, prior to being deported to China.

In an unrelated criminal case, SK Labs and Patel are under criminal indictment, along with USPLabs LLC and its executives.

In 2016, federal prosecutors charged an Alabama man with receiving and reselling misbranded male enhancement drugs from China. According to a plea agreement referenced in an FDA news release, the defendant, Nabil Chagri, received and sold, or offered for sale, mislabeled male enhancement drugs to wholesale supply stores and gas stations.

Mister compared products containing undeclared active pharmaceutical ingredients (APIs) to the sale of selective androgen receptor modulators (SARMs). According to FDA, SARMs are a class of drugs that pose safety concerns and have been found in products marketed as supplements.

Can FDA Use Mandatory Recalls?

FDA officials must “crack down on the supply chain by creating a deterrent and let these people know that they will be prosecuted,” Mister said. He added FDA should threaten to force a mandatory recall of tainted products, if the companies don’t voluntarily recall them.

In a recent case involving kratom products containing salmonella, FDA invoked its mandatory recall authority. FDA said it was the first time it issued such an order to shield Americans from contaminated food.

Fabricant said FDA could possibly use its mandatory recall authority to crack down on products marketed as supplements but containing undeclared drugs. Since its mandatory recall authority derives from the Food Safety Modernization Act (FSMA), however, FDA can only exert such power over food.

Technically, Fabricant said FDA could treat products adulterated with APIs as a food.

“You don’t have those authorities anyway if you’re not going to put them to the test,” the former regulator said, commenting on the potential for FDA to force recalls of products marketed as supplements but spiked with drugs.

Targeting Tainted Products: A Multifaceted Approach

FDA frequently uses other tools to educate consumers and shield them from potentially unsafe products.

Jeremy Kahn, an FDA spokesman, said products that contain undeclared or unauthorized APIs are refused admission into the United States, and FDA has authority to destroy the products rather than allow them to be exported to the country where they originated.

Consumer outreach is another component of FDA’s strategy to protect consumers. For example, FDA provides notifications for adulterated products identified during shipments through the international mail. In November 2017, FDA advised consumers not to purchase or use S.W.A.G II Platinum 33K, a product promoted for sexual enhancement. Through laboratory analysis, FDA confirmed the product contained sildenafil, the active ingredient in the prescription drug Viagra.

FDA has devoted a webpage to health fraud scams that claim to treat diseases or other health conditions, but are not effective or safe for such uses; a related FDA webpage discloses bodybuilding products labeled as dietary supplements may contain steroids.

Import alerts are another tool used by FDA to prevent unsafe products from getting into consumers’ hands. For instance, FDA has issued an import alert for various imported products tainted with undeclared APIs and marketed as dietary supplements for muscle building, sexual enhancement, weight loss and lifestyle. The companies and their products come from Brazil, Canada, China, Columbia, Hong Kong, Japan, South Korea, Malaysia, Mexico and Taiwan.

FDA field offices can detain any products subject to the import alert without physically inspecting them. FDA has found import alerts are more effective in the “commercial importation arena” versus products bound for IMFs.

In the commercial importation area, Kahn explained, products enter the country through various modes of transportation—including air, mail, rail, truck or ocean—and are “imported for purposes of further supply, manufacture or distribution through formal channels, versus what is seen in the international mail facilities.”

Typically, the importers above enter a declaration of goods to U.S. Customs and Border Protection (CBP) using a CBP system, Kahn explained. ACE (Automated Commercial Environment) is the electronic system through which the trade community reports imports and exports, and the government determines whether products are admissible into the United States.

“Entries of FDA-regulated products are routed to FDA through the ACE system, with some FDA-specific data requirements,” Kahn said.

The electronic information gives FDA the ability to target and screen shipments subject to commercial importation.

FDA finds it more challenging to use import alerts for products destined for IMFs because, in part, the agency must manually inspect parcels.

“In the IMFs, it is more difficult due to the lack of advanced electronic data and the sheer volume of products encountered,” Kahn explained. “In addition, these products frequently contain undeclared ingredients, including prescription drugs and controlled substances, or are intentionally misidentified to avoid detection. This makes it challenging to efficiently monitor products entered through the IMFs.”

IMFs combined receive more than 275 million packages annually, FDA officials disclosed in their recent blog on the pilot program. “It’s estimated that FDA is able to physically inspect less than 0.06 percent of the packages that are presumed to contain drug products that are shipped through the IMFs,” they noted.

Debate on Supplement Regulations

MacCleery of CSPI said FDA should do more to protect the public from tainted supplements.

“I think in general we need much greater traceability and accountability up and down the supplement chain for supplements,” she said. “Even basic registration requirements that allow some product traceability would vastly improve the ability of FDA to get rid of the bad actors and, frankly, would then help ensure that the reputation of the industry as a whole is much better preserved.”

There is no current requirement in the law for companies to register their products with FDA, although CRN has launched a voluntary product registry called the Supplement OWL (Online Wellness Library). Some members of Congress have introduced legislation in previous years that would require manufacturers of dietary supplements to provide registration information to FDA.

Industry leaders have stressed FDA and the U.S. Department of Justice should rigorously enforce the laws already on the books. More supplement regulations, the argument goes, isn’t an effective strategy to solving the problem of illegal drugs masquerading as supplements because criminals aren’t likely to follow additional rules when they don’t bother to abide by—or worse, knowingly and intentionally violate—current requirements.

Amid such debate, FDA continues to struggle with an astonishing volume of undeclared drugs—many of which are falsely labeled as “supplements.”

Concluded McGuffin, commenting on the number of products that tested positive for undeclared APIs during FDA’s pilot program: “Clearly, they [FDA officials] haven’t sent a message that’s loud enough to disincentive whatever profit opportunity there is for the creeps that sell these products.”