February 13, 2019
The U.S. Food and Drug Administration (FDA) took action this week to crack down on the sale and marketing of potentially ineffective and unsafe products, many of which are sold as dietary supplements.
The FDA posted 12 warning letters and five online advisory letters to U.S. and foreign companies that are illegally marketing more than 58 dietary supplements that claim to prevent, treat, or cure Alzheimer’s disease and other serious diseases and health conditions. Unlike approved pharmaceutical medications, these supplements have not been vetted by the FDA, and there’s no proof they work or if they’re even safe to take.
“Simply put, health fraud scams prey on vulnerable populations, waste money, and often delay proper medical care — and we will continue to take action to protect patients and caregivers from misleading, unproven products,” the FDA’s commissioner, Scott Gottlieb, MD, said in a statement released on Monday.
The FDA Warning Letters Require Supplement Companies to Take Steps to Fix Problems Within 15 Days
Although the FDA prohibits the sale of misbranded supplements that claim to treat or cure diseases, the agency doesn’t actually test any of the drugs or the efficacy claims until after the product hits the market.
That means the supplements you buy online or at your local pharmacy haven’t necessarily been tested or reviewed by any outside regulating body. The very same company that stands to profit from the sale of a given supplement is also responsible for the evaluating the safety of and then accurately labeling the product, according to the FDA. It’s only after it arrives on commercial shelves to be purchased that the FDA is responsible for taking action against adulterated or misbranded products.
One of the ways the FDA can take action is via warning letters that the agency issues to companies, citing the supplement or supplements in question and listing the efficacy claims that have been made on the product’s website, on social media, or in advertisements that are in violation of the law.
One of the 12 warning letters sent this week was sent to Earth Turns LLC, in regard to several products. In that letter, the FDA cites the following questionable claims made on the company website for its “Green Tea Extract” product:
- “Green tea may also help to reduce the occurrence of Alzheimer’s disease.”
- “Green tea also works to block the proteins that can cause plaque to develop and lead to Alzheimer’s disease.”
- “Studies have shown that green tea supplements may help to fight the accumulation of proteins that can lead to Alzheimer’s disease.”
The FDA’s letter goes on to detail other ways the company has violated the Food, Drug, and Cosmetic Act by making claims that indicate that the product is intended to be used as a drug.
When a company receives a warning letter it has 15 business days to respond in writing. They must detail specific steps that have been taken to correct the violations along with a plan to ensure that it won’t happen again. If the company disagrees with the FDA’s assessment, they must show that they aren’t in violation of the law. The company can also ask for an extension beyond the 15 days.
If the company fails to comply, the FDA can take further measures. In most cases the FDA asks the company do a voluntary recall of the product, which has had mixed results. In a 2014 study published in JAMA, investigators found that some supplements that had been previously subjected to recalls remained on sale, sometimes years after the recall.
FDA Simultaneously Issues Statement Vowing to Modernize and Improve Supplement Oversight
Congress passed the Dietary Supplement Health and Education Act 25 years ago in an effort to regulate supplements, but the landscape has changed and grown dramatically. According to the FDA statement, the supplement industry has grown 10 times larger, from 4,000 unique products and a $4 billion industry to 50,000 products and $40 billion.
In separate statement, also issued this week, Gottlieb outlined enhanced plans to improve the safety of supplements and protect consumers. The steps outlined include:
- Utilize a “rapid-response” tool to alert consumers about unlawful or dangerous ingredients.
- Improve the process for companies to submit new dietary ingredient notifications for safety evaluation.
- Form a government-industry committee to work together to improve the safety and efficacy of supplements.
- Develop new enforcement strategies for supplements that contain unlawful ingredients.
The ultimate goals are to preserve consumers’ access to lawful supplements, protect the public, and enforce the existing laws, Gottlieb noted in the statement.
“One of my top goals is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products, and holding accountable those actors who are unable or unwilling to comply with the requirements of the law,” Gottlieb’s statement noted.
The FDA was not available to provide additional comment about Gottlieb’s statement or the agency’s 17 letters issued this week.
Experts Outside the FDA Doubt the Agency’s Steps Will Create Real Change
These announcements may be a positive sign that the FDA is recognizing the size of the public health problem that illegal supplements pose, says Pieter Cohen, MD, an associate professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts, and the author of a commentary on the lack of regulation in the supplement industry published in JAMA Network Open in October 2018.
“There are tens of thousands of people ending up in emergency rooms due to adverse events from supplements and thousands of people being hospitalized every year in the United States because of supplements,” says Dr. Cohen. Cohen’s recent commentary was a response to a report published in the same issue of JAMA Network Open that found nearly 750 dietary supplements marketed and sold between 2007 and 2016 contained unapproved pharmaceutical ingredients and may have been illegally marketed during that time.
“My concern is that in response to that real public health problem we’re getting a lot of hand waving and not a lot of anything concrete,” says Cohen. Other than the several warning letters sent out to companies who were selling supplements that were claiming to treat Alzheimer’s disease, no really new actions were taken, he says.
The lack of a concrete plan by the FDA makes Cohen doubt that the supplements that consumers are taking will be any safer in the near future. “This doesn’t change anything in terms of my opinion about the FDA and their ability to regulate supplements. They haven’t been doing it for decades, and there’s nothing that they said today that suggests that anything will be different tomorrow,” says Cohen.
When the FDA issues warnings or public notices there are many cases where the offending company doesn’t comply, and the products remain on the market. In a recent research letter published in JAMA Internal Medicine in December and co-authored by Cohen, researchers examined 21 brands of supplements that were cited by the FDA in a public notice because they contained an illegal stimulant. Three years later, more than half the brands were still available for purchase.
“The only good news here is that the commissioner is talking about supplements,” says Cohen. “It’s clear to him that there’s a perception that the FDA is not doing its job in terms of protecting the public, and that’s true — right now they aren’t protecting the public.”
If the FDA wants to fix the problem, they need to both increase their enforcement in the current environment and tell Congress that under the current law there’s no way they can make the market safe, says Cohen. “The FDA needs more enforcement authority to ensure that supplements are safe,” he says.
What to Do if You or a Loved One Takes a Supplement for Alzheimer’s Disease
There is no guarantee that any immediate action will be taken to recall ineffective or unsafe supplements claiming to treat Alzheimer’s disease. Even if the FDA determines a product is noncompliant, it can take several months for the company to communicate a recall to consumers and to take other appropriate actions to remove the product from the market. The FDA does have the authority to pull a product from shelves, but this rarely happens.
The FDA does, however, provide guidance to help you determine if the supplement you are taking or considering is worthwhile. The advice calls for consumers to:
- Be wary of things that sound “too good to be true.” If a supplement makes claims that contradict what your doctor or other reliable sources have told you about the disease, be skeptical.
- Question any product that claims to be a “scientific breakthrough.”
- Check with your doctor about any supplement you plan to take before you buy it.