FDA threatens to take "swift and strong" enforcement action without warning, including filing criminal charges, against manufacturers, suppliers and distributors of tainted supplements, according to a letter sent to industry Dec. 15.

FDA's warning comes "in light of the increasing number of products FDA has found that test positive for" undeclared and unapproved active pharmaceutical ingredients, analogues and novel synthetic steroids that do not count as supplements, Commissioner Margaret Hamburg says in the letter.

"When the evidence warrants, felony charges may be appropriate." – FDA

The letter clarifies developing policy that the agency has previewed through enforcement actions and podium speeches.

"Since September 2007, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements. Most of these products are marketed in three categories: weight loss, sexual enhancement and body building," FDA Principal Deputy Commissioner Josh Sharfstein said in a same-day briefing.

Specifically, FDA facilitated recalls of more than 70 sexual enhancement products, 40 weight loss products and 80 bodybuilding products, according to the letter.

Likewise, FDA lab tests revealed "an alarming variety of undeclared active ingredients marketed as dietary supplements, including" anticoagulants, anticonvulsants, HMG-CoA reductase inhibitors, phosphodiesterase type 5 inhibitors, nonsteroidal anti-inflammatory drugs and beta blockers, Hamburg writes.

"This is progress, but we cannot claim success," Sharfstein added. "Far too many suspect products continue to be advertised online and elsewhere and that is why today, to protect the public, FDA is stepping up our effort."

Enforcement Weapons In The Arsenal

FDA threatens in the letter to "initiate criminal investigations to hold accountable those who violate" the law "and endanger the public health."

While the agency will target companies, it could use Park Doctrine authority to go after "responsible individuals, even if the individual did not participate in, encourage or have personal knowledge of the violation," Hamburg notes (Also see "FDA Targets Executives With Powerful Misdemeanor Strategy" - Pink Sheet, 26 April, 2010.).

"When the evidence warrants, felony charges may be appropriate," FDA warns.

The director of the Office of Regulatory Affairs' Office of Enforcement outlined FDA's shift away from warnings, especially repeated warnings, in favor of actions, at a Food and Drug Law Institute conference in October (Also see "FDA Issues More Warning Letters, Drops Follow-Up Letters In Favor Of Action" - Pink Sheet, 25 October, 2010.).

The agency will treat skeptically any claims that ingredients and products were accidentally tainted. "Active ingredients at meaningful levels do not appear by accident in a product marketed as a dietary supplement – somewhere in the supply chain, the active ingredient is incorporated into the ingredient or the finished product," the letter says.

United Industry Front

Trade groups welcome prosecution against firms that spike supplements and tarnish the industry's reputation, said John Gay, executive director and CEO of Natural Products Association.

Violators do not need another warning letter, "they need criminal action." – CRN's Steve Mister

In an interview, Gay noted the letter is the first time FDA "bluntly" and "clearly" laid out the obligations and responsibilities for those that taint these products and noted that the penalties could include criminal prosecution.

This is the first time FDA has teamed with industry to underscore the seriousness of the problem, Council for Responsible Nutrition President and CEO Steve Mister said.

CRN, Consumer Healthcare Products Association, American Herbal Products Association and United Natural Products Alliance also fully support increased enforcement.

They say in a release that they "endorse FDA's action to use its regulatory muscle to hold accountable those who violate the law and jeopardize the public health, using tough criminal sanctions when appropriate."

Mister added in an interview that he hopes FDA follows through with its claim to take criminal action without sending firms additional warning letters. This letter serves as a warning to the whole industry, he added, noting violators do not need another warning letter, "they need criminal action."

The agency also promises to alert the public about the dangers posed by specific tainted supplements through a new RSS feed on FDA's website before contacting firms to discuss recalls and potential consequences, according to the letter.

New Tools

FDA says in the letter it wants the supplement industry to help it weed out bad actors from the good by reporting any suspected tainted supplement ingredients or finished products and the manufacturers and distributors who market these products to FDA via a dedicated e-mail address – TaintedProducts@fda.hhs.gov – or an anonymous reporting form at http://www.fda.gov/oic.

While the website is not new, Sharfstein said FDA has not encouraged dietary supplement companies before to use it to identify problematic firms.

Likewise, FDA created the e-mail address at the request of industry trade groups because firms did not know how to report questionable material from and practices by other firms, Gay and Mister said.

In their joint statement, the five trade groups encourage companies "to make use of the new tools FDA has made available to industry to report any suspected tainted supplement ingredients or finished products."

FDA Recommends Supply Chain Review

FDA expects firms "vulnerable to potential adulteration" to "understand and investigate their full supply chain and review their manufacturing and quality assurance activities" to ensure they comply with good manufacturing practices, the letter says.

The agency urges companies to pay particular attention to the three product categories where adulteration most often occurs: products for weight loss, sexual enhancement and bodybuilding.

Firms can ensure the integrity of their supply chains by establishing specifications for components used to make supplements; verifying specifications are met; maintaining records; and qualifying suppliers, among other actions, the letter notes.

The agency also seeks additional strategies to combat tainted supplements, according to the letter.

Gay said the industry and FDA are considering several additional measures, but "nothing mature" that "either side is ready to run" with yet.

CRN suggested FDA inspect more ingredients at the border and pay closer attention to materials from or to companies that already recalled supplements.

An earlier suggestion to create a dietary supplement registry to find tainted products recently sparked heated debate at CRN's annual conference (Also see "Suggested Supplement Registry To Root Out Spiked Products Sparks Debate" - Pink Sheet, 18 October, 2010.).

PR Net Impact Should Be Positive

FDA paired the letter with a push to educate consumers about the existence and risk of tainted supplements, but industry leaders are not worried about bad press impacting legitimate supplement sales.

Mister says the trade groups' rare united front and support of FDA's crackdown sends the message to consumers that the industry takes this problem seriously and that these products are illegal outliers.

Sharfstein differentiated between "the dangerous products out there [that] are undermining consumer confidence" and "legitimately marketed supplements," which underscores the safety of some supplements.

FDA also clarified in consumer materials that it regulates legitimate supplements – a point of confusion for many consumers.

Mister added CRN will step up consumer education to help them distinguish between safe supplements and illegally tainted products.

By Elizabeth Crawford

FDA, Trade Groups Team Up To Bolster Enforcement On Tainted Supplements

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