Walk into a pharmacy, grocery store, or vitamin shop and you’re likely to see dozens of so-called “dietary supplements.” You might think that someone, somewhere, has tested these products to make sure they contain what they say they do, and that they are safe. After all, no pharmaceutical can be sold until the Food and Drug Administration (FDA) has clear proof that it is both safe and effective. But when it comes to dietary supplements, you’re probably wrong.
A recent investigation by the New York State Attorney General’s (“NYS AG”) office into store-brand supplements at four national retailers – GNC, Target, Walgreens, and Wal-Mart – gave us another reminder of this. Through a process called DNA barcoding – which identifies individual ingredients through “genetic fingerprinting” – the NYS AG tested 24 products, and found that popular supplements such as Ginseng, Valerian Root, and St. John’s Wort sold under store brand names contained DNA that was either unrecognizable or from a completely different plant.
The NYS AG sent out cease and desist letters to the four retailers instructing them to stop selling the misleading – and potentially harmful – products. “Contamination, substitution and falsely labeling herbal products constitute deceptive business practices and, more importantly, present considerable health risks for consumers,” said the letters, first reported by the New York Times.
There were some differences across stores. Of the four retailers, Target’s supplements were the least misleading. Target’s Echinacea pills, for example, mostly contained Echinacea. But that isn’t saying much. Target’s store brand Ginkgo Biloba, St. John’s Wort, and Valerian Root were found to contain none of the advertised ingredients, and instead consisted of powdered rice, beans, peas, and wild carrots. Wal-Mart was the worst offender: None of the six supplements tested contained the ingredient advertised. Perhaps most alarmingly, however, was this: Wal-Mart’s ginkgo biloba pills did not contain any trace of ginkgo biloba and consisted entirely of powdered radish, houseplants, and wheat, while at the same time being labeled as wheat- and gluten-free. If you have Celiac disease and are gluten-intolerant, that’s a major, and potentially dangerous, problem.
One supplement manufacturer and a number of critics have challenged the NYS AG’s methodology, claiming that DNA barcoding is inappropriate and insufficient to detect ingredients. These critics argue that although the manufacturing process may have destroyed the some of the DNA of the herbs, that doesn’t mean the original product isn’t there. They also claim that the “contaminants” may be acceptable fillers. However, this doesn’t explain the fact that some tests found product, and others didn’t – even within the same brand. Further, as the NYS AG has pointed out, the absence of DNA does not explain the high percentage of contaminants found in these products.
Regardless, the NYS AG’s investigation is a stark reminder that when researchers take a closer look at dietary supplements, the results can be alarming.
There is a big misconception that dietary supplements face the same rigorous oversight that pharmaceuticals receive from the FDA. They don’t. Dietary supplements are not tested for safety and efficacy before they are sold. Many of the supplements are not made in accordance with minimal standards of manufacturing. Many supplements are mislabeled, accidentally or intentionally, by the manufacturers. And there is little the FDA can do about it.
Under the Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938, the FDA has the mandate to regulate the processing, manufacture, and packaging of dietary supplements. Pursuant to the FFDCA, the FDA has the authority to deem food misbranded (i.e. inaccurately labeled or presenting unapproved claims) and adulterated (i.e. containing ingredients that pose a significant or unreasonable risk of illness or injury). However, the Dietary Supplement Health and Education Act (DSHEA) of 1994 effectively eliminated the FDA’s role in policing supplement manufacturers. Instead, the current regulatory regime asks the fox to guard the henhouse.
Here’s how an October, 2012, Department of Health and Human Services Office of Inspector General’s (OIG) report described the extent of the FDA’s regulatory authority:
DSHEA does not require manufacturers to submit dietary supplements to FDA for safety or approval prior to sale. As a result, FDA has no comprehensive list of dietary supplements on the market. Dietary supplement manufacturers must ensure that their products are safe, they have evidence to substantiate structure/function claims, and that product labels are truthful and not misleading.
There is a lot of confusion about structure/function claims, and that confusion goes to the heart of the regulatory problem with dietary supplements. FDA prohibits dietary supplement manufacturers from making disease claims: statements that their product will diagnose, cure, mitigate, treat, or prevent a specific disease (for example, “calcium is used to treat osteoporosis”). Supplement manufacturers can, however, make structure/function claims: statements describing the role of their nutrients’ or dietary ingredients’ intended effect on the structure of function of the body (for example, “calcium builds strong bones”). This distinction, however, is often challenging, even to the FDA.
From the 2012 report: “Although the FDA has issued regulations and published guidance describing the difference between structure/function claims and disease claims, it acknowledges the challenge of distinguishing between the two.” If the FDA has trouble interpreting DSHEA and its own regulations, imagine the problems everyone else has “distinguishing between the two.”
The OIG report continues by describing the three requirements for placing a structure/function claim on a supplement label: “(1) substantiation that the claim is truthful and not misleading, (2) notification to FDA within 30 days of marketing the supplement with the claim, and (3) a disclaimer on the supplement label.” Substantiation of structure/function claim means: “Manufacturers must have substantiation for the structure/function claims on their products’ labels to ensure that they are truthful and not misleading.” All well and good, right? Wrong. This substantiation requirement is significantly limited by the fact that “[i]n any legal proceeding concerning structure/function claims, FDA must prove that the claim is false or misleading.” Further, “DSHEA does not require manufacturers to submit the substantiation requirement to FDA to determine its adequacy and FDA may not compel manufacturers to produce substantiation upon request.”
So, to briefly summarize: Under the DSHEA, dietary supplement manufacturers must substantiate structure/function claims, but they are under no legal obligation to share that substantiation with the FDA even if the FDA asks for it. All the manufacturer has to do is notify the FDA of the structure/function claim and slap a warning that the FDA has not verified the claim. Then it’s off to market. The burden is then on the FDA to identify risky supplements, even though the FDA does not have a comprehensive list of dietary supplements on the market. And if the FDA challenges a manufacture in court, it is up to the FDA to prove that the claim is false or misleading.
How is the industry doing with substantiating its structure/function claims? Poorly. Even with lax regulation, a recent sampling of 127 supplements marketed for weight loss and “immune system support” revealed manufacturers did not comply with FDA guidance on proper substantiation of claims. The FDA attempted to look at more supplements, but only 61% of the manufacturers complied with its request for information (remember: manufacturers are not under any legal obligation to comply with an FDA request for substantiation). Based on its review, the OIG concluded:
- 56 percent of substantiation was derived from in vitro and animal studies, which are not primary sources of evidence and therefore may not be sufficient to support structure/function claims. According to the FDA, these studies would be considered “background information.”
- Only 2 percent of the 557 human studies the FDA reviewed studied the actual products being marketed. The remaining 98 percent focused on an active ingredient that was in a different form, dose, or potency. For example, evidence submitted to support a weight loss supplement’s claim that it burns fat because it contains a green tea extract actually involved a study of drinking green tea.
- Most human studies did not appear to represent the totality of evidence. Despite a large body of scientific evidence contradicting existing structure/function claims, 96 percent of the human studies the FDA received were favorable to the supplements’ claims. Four percent (20 studies) had results that contradicted the claims of sampled supplements.
- Most human studies were not consistent with FDA guidance on quality. Overall, 85 percent were not randomized, double blind, parallel group, placebo-controlled trials. In addition, 49 percent of the human studies were not based on populations similar to those that will be consuming the supplements. For example, one study tested a supplement in elderly women with diabetes. This study (as opposed to one which used a representative sample of healthy individuals) could not be expected to translate to the general population.
- Thirty-four percent of the human studies focused on disease research rather than the meaning of the structure/function claim. Per the FDA: “If substantiation documents demonstrate a supplement’s effect on a disease, they raise questions about the implied meaning of the structure/function claim.”
- Ten percent of documents did not qualify as substantiation at all. For example, “one company submitted a 30-year-old handwritten college term paper to substantiate its structure/function claim, while other included articles from trade newsletters; press releases; advertisements; and links to Web pages, such as Wikipedia or an online dictionary.”
The market is glutted with dietary supplements, from multivitamins to herbal cures for everything from the common cold to obesity. These products, supplement companies often argue, are natural and thus, safe. Most people, however, are not aware of the weaknesses in the scientific data on supplements. The public is still faced with examples of inconsistent potency and quality, unsubstantiated claims made by manufacturers, and illegal or unapproved ingredients that render supplements adulterated. The most recent investigation by the New York State Attorney General is yet another reminder of this.
To its credit, the FDA has taken steps in recent years to address oversight of dietary supplement safety. However, they’ve faced fierce opposition from the dietary supplement industry and in Congress. More FDA guidelines, they say, will be bad for business.
But without additional regulatory pressures, there is little motivation for the $32.5 billion supplement industry to improve its practices and stop misleading the public. At a minimum, supplement companies should be required to provide (1) scientific evidence demonstrating that their product is safe prior to them being marketed to the population, and (2) substantiation for their claims of health benefits. Dietary supplements should, in other words, be regulated much in the same way as the FDA regulates pharmaceuticals.
Lest you think this is overkill, consider this: The most current research on dietary supplements indicates that “[m]ost supplements do not prevent chronic disease or death, their use is not justified, and they should be avoided.” What’s more, not only are vitamins not beneficial for most of us, some supplements, such as fish oil, actually increase the risk of disease and death in certain individuals. So if regular supplement intake is ineffectual at best, and harmful at worst, why don’t most of us know it? Why haven’t FDA officials made sure we are aware of the dangers? Good question. And by now we know the answer. They can’t. And that needs to change.