To report IS
Hundreds of ‘natural’ supplements contain experimental drugs – and the FDA knows but doesn’t tell the public, report warns
- Supplements can be sold over the counter because they supposedly don’t contain active pharmaceutical ingredients
- But between 2007 and 2016, the FDA found 776 supplements were not what they claimed to be – and most contained drugs
- Yet it only issued recalls for less than half of those, a new study from the California Department of Food and Agriculture found
Natalie Rahhal Health Reporter For Dailymail.com
Hundreds of over-the-counter supplements are laced with unapproved drugs, according to FDA tests – but the agency doesn’t issue recalls on them, a new report reveals.
Most of the offending products were sold as male sexual enhancement, muscle building and weight-loss supplements.
Researchers at the California Department of Food and Agriculture (FD) discovered that more than 775 purportedly ‘natural’ supplements contained cheaper versions of the advertised ingredients or pharmaceutical compounds that require a prescription.
But the FDA only recalled half that number.
Experts are hitting back at the US Food and Drug Administration (FDA) for letting these tainted products slip onto and stay on the market, calling the study evidence of a ‘dereliction of duty.’
Hundreds of purportedly ‘natural’ supplements contain experimental versions of pharmaceutical drugs, according to FDA testing data, but the agency fails to recall them
In 2017, supplements were a $13.4 billion industry – and the market is only predicted to continue to climb.
With countless kinds, brands, and vendors out there, the supplements industry keeps the FDA’s hands full.
Because they are not supposed to contain active pharmaceutical ingredients, the supplements don’t have to be approved by the FDA before they hit the shelves.
But the agency is responsible for testing any suspicious products and issuing recalls if they contain any mislabeled, potentially dangerous or unapproved ingredients.
The new study found that the agency is testing these products – but it isn’t acting on its findings.
Between 2007 and 2016, FDA chemists found that 776 supplements were ‘adulterated,’ meaning they contained different ingredients than what was advertised on their labels.
But the agency only issued voluntary recalls on 360 products – less than half the number of adulterated products they actually found.
Of those the majority – 353 – were marketed for sexual enhancement, 317 were for weight loss, and 92 were for muscle building. A handful of supplements fell into the ‘other’ category.
Some of these contained a cut-rate downgrade of the advertised ingredients, but of much more grave concern, many of the supplements that were marketed as ‘natural,’ contained often-experimental versions of pharmaceutical drugs.
Nearly half of the male sexual enhancement drugs contained sildenafil – or some shoddy version of it – the active ingredient in Viagra.
‘Consumers should not think that this is a just a cheaper way to pick up their Viagra, though,’ Dr Pieter Cohen, a primary care doctor and professor at Harvard Medical School, who wrote a commentary accompanying the JAMA report told Daily Mail Online.
‘No, it’s an experimental version of Viagra, and we don’t know the dosage. In some cases, it’s a version of the pharmaceutical that’s been removed from the market.’
Sibutramine, a potentially dangerous weight-loss drug was found in 85 percent of the adulterated slimming supplements and steroids or steroid synthetics were in nearly 90 percent of muscle building supplements.
These supplements don’t have to be tested in humans. Instead, manufacturers experiment with fruit flies and mice.
But the drugs that find their ways into supplements are not to be taken lightly.
Dr Cohen says that each drug is associated with thousands of hospitalizations a year, and supplements themselves lead to 2,000 annual hospitalizations.
These categories of supplements are particularly prone to having manufacturers use pharmaceutical ingredients because ‘these three categories have pharmaceutical drugs that can help with these things,’ Dr Cohen says.
‘The law permits supplements to be sold as if they work in humans, and that creates a perverse incentive for [manufacturers] to sneak something in there so it will actually work.’
But without controlled dosage or tests in humans, consumers don’t know if they supplements they’re taking are safe.
‘There are actively experimental drugs in supplements that the FDA is aware of but they are not sharing that information with the public,’ says Dr Cohen.
‘This is very disturbing.’
What isn’t clear is why it’s happening.
Dr Cohen says that the FDA could claim that it’s short-staffed, but ‘the [testing] work is being done, it’s just not being followed up.’
Alternatively, he says there could be a ‘bureaucratic mess’ brewing in the FDA, where a mountain of paper work awaits when the agency wants to make a recall, ‘but that’s their job.’
Admittedly, voluntary recalls don’t work particularly well, but Dr Cohen says that the FDA rarely reaches into its deeper toolbox to issue mandatory recalls or go to the Justice Department.
Plus, ‘the recalls aren’t completely effective, but the FDA isn’t even bothering to recall many of these products,’ he says.
‘How we can have the premier public health agency not getting its job done is completely mystifying,’ he said.
Hundreds of 'natural' supplements contain active drugs and the FDA knows but doesn't tell the public