Postage Due: FDA Stamps Enforcement On Spiked Supplement Found In International Shipments

Most products identified in public notifications contain weight loss or ED drugs, but two contained fluoxetine, for treating depression, bulimia and obsessive-compulsive, panic and premenstrual dysphonic disorders. Using personal mail for commercial shipments is some importers only chance of getting products in the U.S.

FDA finds a wave of products marketed as supplements but spiked with drug ingredients through an “examination of international mail shipments” in enforcement likely targeting commercial imports in personal packages.

Most of the products identified in 26 public notifications published between Feb. 25 and March 5 contain Rx ingredients indicated for weight loss or erectile dysfunction.

In three products – Botanical Slimming, Natural Max Slimming and Oxy Elite Pro Super Thermogenic – FDA officials found fluoxetine, a selective serotonin reuptake inhibitor for treating depression, bulimia, and obsessive-compulsive, panic and premenstrual dysphonic disorders. However, the firm that markets Oxy Elite brand products, [USPlabs LLC], says the fluoxetine product is counterfeit.

FDA’s notifications stated these products promoted for sexual enhancement were found to contain ED ingredient sildenafil: Viagra: 72HP, African Superman,Baolong,Bigger Longer, Black Ant King, Black King Kong, Black Mamba Premium,FX3000, Germany Niubian, Hard Wang, Herb Viagra, La Pepa Negra, Libigrow XXX Treme, Male Silkworm Moth Nourishing Oral Liquid, MME Maxman, Plant Vigra, Rhino Blitz Gold, Sex Men, Stiff Nights, Super Hard,Tibet Babao,Vigour 300, Vigra and Vim-25.

Products marketed for weight loss and identified in FDA’s notifications as containing drug ingredients were Seven Slim and Nine Slim with phenolphthalein, a chemical not approved in the U.S. and suspected for being a cancer-causing risk; Black Mamba Hyperrush, Elimulating Weight & Toxin Keeping Beauty and L-Carnitine with sibutramine, which the agency banned in 2010 due to safety reasons; and Diablos Eca Fire Caps,Lean Body Extreme with phenolphthalein, sildenafil and sibutramine.

While phenolphthalein and sibutramine are not approved for use, sildenafil is the active ingredient in Pfizer Inc.’s Viagra. Pfizer has said it provides data about manufacturers of products sold as supplements but tainted with sildenafil or other ED active ingredients or analogs to help FDA’s Office of Criminal Investigations, FBI and local law enforcement cut off the supply (Also see "Pfizer Shares Data On Spiked Supplements With FDA, Enforcement Agencies" - Pink Sheet, 19 Sep, 2013.).

FDA’s notifications did not identify the firms linked to marketing the spiked products.

Trouble Comes In Small Packages

A search of FDA’s website showed no previous public notification or other announcement concerning spiked supplements included the statement that a product “was identified by FDA during an examination of international mail shipments.” In the agency’s lists of spiked supplements promoted for sexual enhancement and weight loss, all notifications before those starting Feb. 25 do not include a reference to examining international mail.

The agency routinely imposes import alerts to block entry of dietary supplements suspected of being spiked with drug ingredients or otherwise adulterated, including products from firms found with substantial good manufacturing practices violations (Also see "Supplement GMP Violations Stop Mexican Firm’s Herbal Imports" - Pink Sheet, 15 Jan, 2015.).

However, the notifications FDA published since Feb. 25 tap into an approach to keeping spiked supplements off the market that relies on identifying importers who are high risks for distributing violative products and picking out their packages shipped as personal mail.

FDA’s reference in the notifications to examining mail shipments likely indicates the products were found in personal mail – packages valued at less than $200 and typically intended for consumers – rather than in bulk shipments of goods intended for distributors or retailers. Some personal packages, though, are strictly for business.

But examining imports in personal mail, the agency says, is not its strong suit.

“Because the amount of [FDA-regulated] merchandise imported into the United States in personal shipments is normally small, both in size and value, comprehensive coverage of these imports is normally not justified,” according to the agency’s Regulatory Procedures Manual for Inspections, Compliance, Enforcement, and Criminal Investigations.

“They’ve always had the authority to do this. It doesn’t seem outside the norm if FDA has a concern in a certain area to focus on the area,” said Dara Katcher Levy, a partner at Hyman, Phelps & McNamara P.C. in Washington.

And the agency states in its Investigations Operations Manual that it “may conduct periodic ‘blitzes’ to determine the volume and type of FDA-regulated goods admitted” as personal mail, which does not receive the same scrutiny at U.S. ports receiving international mail.

Collaborating With Customs

FDA relies on U.S. Customs and Border Patrol officials at international mail facilities to identify questionable personal packages that potentially contain products or substances subject to the agency’s review.

Levy, who focuses on Rx drug promotion and import law, says in addition to packages containing products or shipped from businesses FDA has identified as high-risk, Customs officials look for personal shipments that appear more commercially purposed.

“This usually gets covered if there is a thought by them that the product might be redistributed instead of used for personal reasons,” she said.

Collaboration between the agencies, says Ben England, a former counsel to FDA's associate commissioner for regulatory affairs, also can include FDA Office of Criminal Investigations officials “steadily trying to build a case” against fraudulent importers but determining that shipments of likely adulterated products by the targeted firms should be stopped before charges result from an investigation.

A product branded Oxy Elite Pro Super Thermogenic was one of two, among a total of 15 spiked supplements, FDA officials said contained fluoxetine, an ingredient for treating depression, bulimia, and obsessive-compulsive, panic and premenstrual dysphonic disorders.

From FDA

Even though the sources of the adulterated products likely would not face enforcement in those cases, the agency’s public health focus prioritizes keeping violative supplement, pharma and other goods off the market, said England, now head of FDAImports.com regulatory consultancy in Glen Burnie, Md.

“The FDA’s walking a fine line. They’re a public health agency primarily, but yet they have criminal investigators,” he said.

Council for Responsible Nutrition President and CEO Steve Mister noted some firms outside the U.S. likely do not get products promoted as supplements into the country through any means other than commercial packages shipped as personal mail.

“Our understanding is they do come in small packages intentionally to avoid detections,” Mister said.

He added that the spiked products FDA intercepted are not from compliant firms. “I think the people who are ordering supplements from reputable firms don’t have anything to worry about.”

Natural Products Association Executive Director and CEO Daniel Fabricant said FDA’s enforcement against 26 violative import products could indicate the agency is relying more on mobile devices for determining ingredient identity. Announcements that products are spiked after testing on-site at mail facilities can be made faster than testing after a product is transferred to an FDA lab.

“It’s not like going to a store and pulling it for samples,” Fabricant said.

USPlabs said it “immediately conducted an investigation” and determined it did not make or distribute the product identified in FDA’s public notification. “Neither USPlabs nor its contract manufacturers have ever ordered or in any way handled fluoxetine for any purpose of any kind,” according to the firm, which has tangled with FDA previously concerning sports nutrition products containing DMAA (Also see "DMAA Product OxyElite Pro Named Potential Link In Acute Hepatitis Cases" - Pink Sheet, 9 Oct, 2013.).

The Dallas firm March 1 said it has not manufactured Oxy Elite Pro since October 2013 and its final lot of the product had an expiration date of October 2016, while the expiration date on the package FDA identified is April 2017. USPlabs pointed out its “genuine” Oxy Elite Pro capsule products had lot numbers beginning with 4, but the lot for the product FDA identified is a number the firm has not used for any product.