The FDA isn’t quality-monitoring drugs and products the way you think they are
When David Light first founded Valisure, an independent lab most famous for detecting cancer-causing chemicals in products including antacid medicine, sunscreen, hand sanitizer, and dry shampoo, he was surprised to learn about the broad misconceptions about the supply chain and how the FDA actually works. “I think a lot of people assume that an FDA-approved product in the United States – every bottle has been tested and your pharmacy is checking,” says Light. “All of these elements actually aren’t true.”
“I think a lot of people assume that an FDA-approved product in the United States—every bottle has been tested and your pharmacy is checking. All of these elements actually aren’t true.”
The FDA’s purpose is to be a regulator over the data and testing of new drugs, but that’s “not the same as quality-monitoring once [a drug or product has] already been approved and is being manufactured, especially with generic drugs.”
Many consumers don’t realize that product testing is almost exclusively done by the manufacturers themselves and is self-reported to the FDA. The FDA may do inspections of the facilities, but they’re not checking the chemical quality of a product.
“I think we often defer that silver bullet to the FDA. We say that, ‘Oh, everything is quality-perfect in the United States because we have the FDA,’ ” Light explains. “But you can’t defer everything to one organization to police the entire planet. It’s just not possible.”
That’s where Valisure comes in to independently test and certify products before they go to consumers and patients.
A product with a carcinogen problem can either be contaminated in the manufacturing process, or the ingredients themselves are unstable, forming the carcinogen over time
A product can develop a carcinogen problem in a few different ways. One, is with a product like Zantac where the active ingredient, ranitidine, was found to be fundamentally unstable. Valisure tested the drug when the infant daughter of the company’s cofounder was prescribed it. They ran the ranitidine syrup through their testing and found high levels of the carcinogen NDMA. They realized that “it’s not just potentially contaminating some batches, but was actually fundamental to the drug itself. The drug was unstable and forming NDMA at potentially very high levels,” explains Light. “And that’s what got the drug withdrawn a number of months later.”
Another way products may contain carcinogens is by a contaminant in the manufacturing process. With products like sunscreen or antiperspirants, some batches might be contaminated while others are not. Valisure found the carcinogen benzene in many of these beauty and wellness products, but what’s important to note is that “you’re not going to find it on a label.” Benzene is a manufacturing contaminant often found in the petroleum industry. Products that use propellants in their aerosol sprays – the same propane and butane used in your lighter or propane grill – can also become contaminated with benzene. These ingredients are supposed to be at a pharmaceutical grade, but unfortunately that isn’t always true.
“There’s raw materials that are coming from who knows where at the beginning of the supply chain,” says Light. The materials then get formulated, packaged, and distributed to a store where consumers eventually buy them. There’s no point along the supply chain where someone is picking up these contaminations. “It’s an important case study to underscore how critical it is to insert this concept of independent quality assurance into the supply chain.”
Brand name isn’t necessarily better than generic
Batch variability is one of the key issues in the supply chain. When asked if he’d recommend brand name over generic, Light responds, “It’s a tough question because it’s really going to depend on the company and the drug product.” Whether brand name or generic, “there’s probably more consistency when you stick with one company.”
While 90 percent of American drugs are produced in India and China, plenty of brands have factories all over the world that they switch between. “That affects the brand companies just as much as it affects generic companies,” Light explains. “The provenance of a product is a difficult question. There’s particularly low visibility into that with drugs. You know where your shirts are made. You don’t get any information about that on your drugs.”
“You know where your shirts are made. You don’t get any information about that on your drugs.”
The reason for all this switching – especially at the pharmacy level – is that the market is largely valuing price over anything else. As a consumer, you can’t choose the manufacturer of your generic drugs. “So there’s a lot of concern that that variability can be clinically significant, especially in certain drugs like psychotropics or narrow therapeutic index drugs,” says Light. “It is a fundamental market problem that you, as the consumer, typically don’t have that choice. There’s no transparency.”
Be informed when buying over-the-counter products
For consumers and even scientists, it’s not always easy to keep track of what’s good for you and what’s bad for you when the information is constantly changing. When buying products, it’s important to distinguish between products where there may be an ingredient of concern, and products where there’s a known issue. In the former “bucket,” as Light refers to them, are products where there’s new data that scientists are looking at. These are products that include ingredients like parabens and sulfates. Data suggests that “we should think twice about” using products that contain these ingredients. “Those are areas to be concerned about. It doesn’t mean you don’t use the product anymore.” But you may choose to lower your risk by eliminating these types of products or aerosols, for example, which are more likely to be contaminated with benzene.
Products where there’s a known problem “is a completely separate bucket.” Products known to be contaminated with benzene, lead, and asbestos should absolutely be avoided. “There’s numerous epidemiological studies that directly show the risk of increased cancer in human beings,” says Light of being exposed to these chemicals.
“It is hard to know the real chemical quality of a product in front of you. That makes [for] a lot of uncertainty for consumers.”
Beyond making these educated guesses about the products you buy, “It is hard to know the real chemical quality of a product in front of you,” admits Light. Valisure did their first study on benzene in early 2021 and are still seeing recalls two years later. “That makes [for] a lot of uncertainty for consumers,” he says. “The fact that the regulatory system in the United States is voluntary is surprising to many.” So what can you do? Inquire with the companies who make your products about what they’re doing in terms of independent testing and quality assurance.
There are some product lines that now have marks indicating that they’ve been independently tested, such as CVS’s Tested to be Trusted program that uses a third party to test all vitamins and supplements sold in-store. “More and more we’re starting to see that engagement with industry,” says Light, but you should still make sure to check what a product’s trust badge actually means.
“[There’s] no better action than taking it upon yourselves to actually look at what’s out there—vote with your actions as a consumer.”
One resource Light recommends is Consumer Lab, which uses Valisure and other scientific data to create product recommendations. “The recalls that have ensued and the regulatory actions that have happened underscores that this is a robust science that’s having a lot of impact and needs to be taken quite seriously,” Light says. “But [there’s] no better action than taking it upon yourselves to actually look at what’s out there – vote with your actions as a consumer.”
We need fundamental change in the industry to make a real impact on the safety of drugs and products
With all the data the company has gathered, Valisure’s small team of scientists are getting better at identifying areas that pose the biggest risk. For example, suspecting that gelling agents might be susceptible to benzene contamination led them to the hand-sanitizer recall, which led them to discovering the same issue in suncare products like aloe.
“You can’t boil the ocean overnight,” says Light, noting that there could be thousands of drugs at any given pharmacy. “But [by] focusing efforts in drug products that are higher risk than others, we’re getting more and more sophisticated at where to look and identify these issues, ideally working with the supply chain, preventing [these products] from being on the shelf, and preventing them from being in front of patients where it can actually cause harm.”
“[By] focusing efforts in drug products that are higher risk than others, we’re getting more and more sophisticated at where to look and identify these issues.”
For such a small company to have found issues in a wide variety of drugs and products underscores that it’s going to take more than just marketing and a trust badge to make real change. “For industry to take this seriously is incredibly important… I’m very hopeful that the next five years are going to be really focused on addressing these issues and making things better,” says Light, “not just playing Whac-A-Mole on recalls.”