Contaminated Supplements

How Does the FDA Regulate Nutritional Supplements?

Inadequate Food and Drug Administration (FDA) oversight in premarket nutritional supplements and vitamins manufacturing can lead to potentially dangerous products being sold on the marketplace.

Research has shown that some supplements and vitamins contain dangerous amounts of potentially harmful agents.

For example, one study found some vitamins to contain lead, arsenic, cadmium, and other dangerous metals.

Contaminated supplements pose a threat to consumers, putting them at risk of several serious adverse health effects, including death.

Federal law requires that every dietary supplement is labeled, either with the term “dietary supplement” or with a term that substitutes a description of the product’s dietary ingredient(s) for the word “dietary” (e.g., “herbal supplement” or “calcium supplement”).

In general, FDA’s role with a dietary supplement product begins after the product enters the marketplace.

That is usually the FDA’s first opportunity to take action against a contaminated supplement or product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.

Federal law does not require dietary supplements to be proven safe to FDA’s satisfaction before they are marketed.

For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to the FDA’s satisfaction that the claim is accurate or truthful before it appears on the product.

Once a dietary supplement is available for purchase, the FDA has certain responsibilities.

These responsibilities include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals.

The FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.

Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals.

However, dietary supplement manufacturers do not have to get agency approval before producing or selling these products.

There are substantial limitations to FDA oversight of claims in dietary supplement labeling.

For example, the FDA reviews claims as resources permit.

Under DSHEA, (Dietary Supplement Health and Education Act of 1994) dietary supplements are held to a different standard.

Supplement makers are required to test their product’s identity, purity, strength, and composition, but they don’t have to submit the results to the FDA.

They also have to notify the agency of new ingredients.

But those ingredients are only reviewed for safety and are not subject to any formal stringent approval process.

Part of the problem is a lack of resources within the FDA.

Since DSHEA became law, the number of supplement products has grown exponentially from 4,000 in 1994 to more than 90,000 in 2018.

The FDA’s budget to monitor supplements hasn’t grown in tandem.

The industry currently generates $40 billion a year – the agency’s budget for supplement regulation is but a small fraction of that amount.

To remove a contaminated supplement from the market, the FDA must show that it poses a danger to consumers once it’s already for sale.

This duty falls on doctors, consumers, and supplement manufacturers to report any suspected problems.

However, doctors often do not initially connect an illness to possibly contaminated supplements.

If doctors do connect the illness to contaminated supplements, the doctor might not think to call the FDA.

GAO reports found that over one thousand contaminated supplement-related calls were going to poison-control centers rather than to the FDA.

How do Nutritional Supplements Become Contaminated with Lead, Cadmium, and BPA?

Contaminants can seep into food products from naturally occurring toxic and heavy metals; contaminated soil and water from agricultural farming methods; mine tailing runoffs, as well as storage, silos, and transportation systems that can transfer contaminants as food is stored and transported.

Relaxed oversight in production can allow contaminated supplements to reach the marketplace.

Studies Find Contaminated Protein Powders

The Clean Label Project’s Protein Powder Study for 2018 displayed that of the top 234 selling protein powders a staggering 70% contained detectable amounts of lead, 74% contained detectable amounts of cadmium and 55% had datable amounts of BPA.

BPA is known to cause cancerous tumors, birth defects, and developmental disorders.

One of the protein powders tested was found to have 25 times the allowed regulatory limit of BPA in just one single serving.

The protein powders that were the most contaminated were the powders sourced with a plant-based protein.

In fact, 75% of the plant-based powders tested positive for lead contamination.

The powders that were the least contaminated were sourced with egg as a protein source.

Protein powder supplement contaminants are the result of sourcing and production practices.

Contaminants can be found in soils because of pesticides and mining run-off (ex. heavy metals) and can be absorbed into plants.

Contamination can also occur because of the manufacturing process (ex. BPA/BPS is using the lining of cans and containers and leach into the protein powder.)

BPA is an industrial chemical that has been used to make certain plastics and resins since the 1960s.

Research Exposes Contaminated Supplements, Nationwide

A nutritional industry analysis conducted by California health scientists found a staggering 800 dietary supplements sold in U.S. stores contained unapproved ingredients, including ingredients specifically prohibited or banned by the FDA.

Other over-the-counter supplements contained active materials that require a prescription, such as steroids.

Vitamin Shoppe One Daily Men's 50+ Vitamin Contamination Injuries

The medical issues and side effects that occurred because of the contaminated supplement were:

• Burning sensation
• Hand weakness
• Slurred speech
• Headaches
• Confusion
• Vision issues
• Numbness in extremities

Vitamin Shoppe One Daily Men's 50+ Lawsuit Filed on Behalf of Man Injured by Toxic Daily Supplement for Men in Chicago, IL

Law360, a legal publication, published an article regarding the lawsuit filed.

The article can be read below:

“(June 10, 2019, 9:11 PM EDT) — An Illinois man claims that New Jersey-based Vitamin Shoppe Industries Inc. makes a daily supplement for men containing harmful toxins such as arsenic that can cause bodily damage to those who take it, according to a lawsuit removed to Illinois federal court Monday.

Consumer Harvey Mahler claims the nutritional supplement retailer has illegally misled customers about the ingredients in its “The Vitamin Shoppe One Daily Men’s 50+” supplement. That concealment constitutes negligence as well as several breached warrants over a defective product for which the Vitamin Shoppe should face strict product liability, Mahler claims.

The nutritional supplement retailer removed the suit to federal court, citing the diversity between each party’s home state.

Mahler’s attorney, Eric Terry of TorHoerman Law LLC, told Law360 on Monday that the removal “wasn’t completely unexpected,” but said he plans to analyze the case to try to “find a good reason to get it back in state court.”

But “truth be told,” Mahler’s legal team is confident the case will succeed regardless of whether it’s litigated in federal or state court, Mahler’s other attorney, Tor Hoerman of TorHoerman Law LLC, told Law360.

Mahler, from the Chicago suburb of Evanston, claims he purchased two bottles of the shop’s One Daily Men’s 50+ supplement in June 2017 and took them as instructed. However, he says he began experiencing “several new medical problems” after taking the product, including numbness in his extremities, a burning sensation in his feet, hand weakness, slurred speech, headaches, confusion, and vision issues.

Mahler was subsequently diagnosed with several medical problems, including nerve damage as well as kidney damage that required surgery and stent placement to repair, his lawsuit claims. Laboratory testing conducted later revealed the product Mahler had been ingesting contained unsafe levels of known toxins such as arsenic, cadmium, and lead, according to the lawsuit.

The Vitamin Shoppe should have known about the dangers surrounding those toxins since that knowledge was available at the time it started producing the supplement, Mahler claims. With that knowledge available, the Vitamin Shoppe “should have taken steps” to make sure its product was free of harmful substances before putting it on shelves, he claims.

But the supplement retailer failed to warn customers about its product’s ingredients, according to the lawsuit. It also failed to warn consumers about the risks they would encounter by ingesting its defective product, Mahler claims.

Mahler is asking a judge to award him damages over $50,000, as well as any other relief deemed appropriate over his claims.

Representatives for the defendant did not immediately respond Monday to a request for comment.

Mahler’s suit is the latest of several the Vitamin Shoppe has faced over supplements that have allegedly caused issues for customers.

In August, a New York federal judge refused to let the retailer fully escape mixed martial arts fighter Lyman Good’s lawsuit claiming certain supplements he took contained illicit anabolic steroids that caused him to be suspended from the Ultimate Fighting Championship. The judge overseeing Good’s case had tossed his fraud and battery claims but left Vitamin Shoppe to defend his claim for breach of implied warranty of merchantability.

Mahler is represented by Eric Terry and Tor Hoerman of TorHoerman Law LLC.

The Vitamin Shoppe is represented by Christopher Sean Hennessy of Cozen O’Connor.

The case is Mahler v. Vitamin Shoppe Industries Inc., case number 1:19-cv-03848, in the U.S. District Court for the Northern District of Illinois.”