At the end of last year, FDA identified 28 fraudulent products marketed for weight loss. Last week, it added 41 more tainted items to its hit list.
The agency, which has warned consumers to stop taking the products, said it has already inspected some of the manufacturers. FDA warmed that if the companies do not respond adequately to recall requests it will pursue additional enforcement measures, which could include warning letters, product seizures, injunctions or criminal charges.
Fertile for fraud
The weight loss category has been particularly susceptible to adultery due to a widespread consumer desire to find a ‘quick fix’ to problems of overweight; and the internet has served as fertile breeding ground for the sale of unapproved products that tap into this consumer desire.
However, the category has been under the regulatory spotlight for some time now. Last year, NutraIngredients-USA.com reported that the Federal Trade Commission (FTC), which regulates product advertising, had identified weight loss as a major focus.
“We're never short of targets in the weight loss industry," said Michelle Rusk, from FTC's division of advertising practices. For the full article, click here.
Undeclared pharmaceuticals
The undeclared active pharmaceutical ingredients that FDA found in its latest sweep included sibutramine, rimonabant, phenolphthalein and bumetanide.
Sibutramine is a controlled substance that can cause high blood pressure, seizures, tachycardia (rapid heart beat), palpitations, heart attack or stroke. The drug, which has not been established as safe for pregnant women or children, can also interact negatively with other medications.
Rimonabant is a drug not approved for marketing in the United States. It is said to have been associated with increased risk of depression and suicidal thoughts, and in Europe – where it is approved – it has been linked to five deaths and 720 adverse reactions over the last two years, according to FDA.
Out of the other ingredients detected, phenytoin is an anti-seizure medication, bumetanide is a diuretic and phenolphthalein is a solution used in chemical experiments and a suspected cancer-causing agent.
FDA said some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels.
Industry support
The dietary supplement industry has been quick to express support to FDA’s enforcement action.
Fraudulent or bogus supplement products have dragged down the reputation of the industry as a whole, damaging sales and growth opportunities for safe, scientifically-backed supplements.
“The majority of companies in the dietary supplement industry abide by the law and work hard to provide the more than 150 million Americans who take vitamins and other dietary supplements with safe, high quality, and beneficial products,” said Steve Mister, president and CEO, of supplement trade group Council for Responsible Nutrition (CRN) on Friday.
“We applaud FDA’s efforts to protect consumers from tainted weight loss products that contain active, undeclared ingredients [and support] the Agency’s decision to demand removal of these adulterated products from the market.”
New regulations governing the quality and safety of dietary supplement products in the US started to be phased in last year.
The current good manufacturing practices (GMPs), which have required a major shift in the way companies conduct and record their operations, are expected to maintain quality assurance standards and reduce the risk of contamination.