FDA Uses New Authorities To Get OxyElite Pro Off the Market

By: Daniel Fabricant, Ph.D. 

As the head of the office that oversees dietary supplements, it is my responsibility to ensure that the dietary supplement products on the market — which are used by more than 180 million Americans daily — do not cause harm.

This is not an easy job because FDA’s authority to regulate dietary supplements is very different from the agency’s authority to regulate drugs and medical devices prior to their marketing. Adding to the challenge is the fact that there are more than 85,000 dietary supplement products and no requirement for product registration.

Just recently we had a case that illustrates both the limits of FDA’s authority to regulate supplements and the promise of new enforcement tools provided by the FDA Food Safety Modernization Act (FSMA). Dozens of people were suffering acute liver failure or non-viral hepatitis so severe that several needed liver transplants, and one died. These people, by and large, had been healthy.

The illnesses were linked to certain OxyElite Pro dietary supplement products made by Texas-based USPLabs. Certain OxyElite Pro products and a second product, VERSA-1, contain a new dietary ingredient that has not been shown to be safe for use by consumers. This ingredient, aegeline, is a synthetic version of an alkaloid that exists, in natural form, in a tree that grows in parts of Asia.

This is the second time in little more than a year that USPLabs has produced supplements containing a new dietary ingredient that lack a history of use or other evidence of safety. In the previous case, the company added a stimulant called DMAA (dimethylamylamine) to OxyElite Pro and to a similar product, Jack3D. We were alerted to the addition of DMAA through more than 100 reports of illness, including six deaths, among people who used the products.

Consumers may look at a capsule or tablet, the forms in which many supplements are sold, and not realize our limitations in regulating dietary supplements. In October 1994, the Dietary Supplement Health and Education Act expressly made supplement manufacturers responsible for ensuring that their products are safe. Under this law, manufacturers do not need FDA approval before selling dietary supplements. The burden is generally on FDA to prove that a supplement is unsafe before any actions can be taken to restrict its use or remove it from the market.

The law made an exception for “new dietary ingredients” (i.e., dietary ingredients not marketed in the United States before Oct. 15, 1994). Before supplements containing these new dietary ingredients – vitamins, minerals, herbs and other substances – can be sold, a manufacturer or distributor must provide FDA with information establishing their safety when used under the conditions recommended or suggested in the product labeling. USPLabs should have informed FDA of its plans to add aegeline to its dietary supplements, and it should have established the safety of aegeline in its products. Neither of those things happened.

We do not have the authority to evaluate and approve dietary supplements before they are sold to consumers. However, in this case we were able to invoke new enforcement authorities provided by FSMA to remove them from the market.

Key provisions under the new food safety law – mandatory recall and administrative detention – now play a critical role in allowing FDA to act quickly and decisively. We can now order a recall when there is a reasonable probability that an article of food is adulterated or misbranded under certain sections of the Federal Food, Drug, and Cosmetic Act and there is also a reasonable probability that the articles of food will cause serious adverse health consequences or death to people or animals. 

We also have the authority to administratively detain a food or dietary supplement to prevent its distribution if the agency has reason to believe the product is adulterated or misbranded.

We invoked our recall authority and warned USPlabs that FDA might order it to stop distributing the involved OxyElite Pro dietary supplements if the company did not stop distribution on its own and conduct a voluntary recall. USPLabs agreed to voluntarily recall the OxyElite Pro products and destroy all lots of the products, including remaining warehouse stock, which had an estimated value of $22 million. We will supervise the destruction of these products.

My colleagues and I will continue to use our new authorities, as appropriate, to make sure that the supplements you take will not put you in the hospital. We are committed to keeping you and your family safe, using every tool at our disposal.

Daniel Fabricant, Ph.D., is Director of FDA’s Division of Dietary Supplement Programs

We’re Partnering with Mexico to Keep Foods Safe

By: Michael R. Taylor 

En Español

Food safety is an issue that crosses borders. The reality of this global marketplace is that consumers, industry and governments worldwide are in this together. 

Deputy Commissioner Michael Taylor (on r) and Dr. Ricardo Cavazos, General Director of Economic and International Affairs at the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)

With that in mind, my team and I traveled to Mexico City on Oct. 29, 30 and 31 to discuss the rules that FDA has proposed this year to help ensure the safety of both domestic and imported foods. 

We said at the beginning of our efforts to implement the 2011 FDA Food Safety Modernization Act (FSMA) that we would send FDA delegations to Canada, Mexico, Europe and China to strengthen partnerships with officials there to help accomplish our safety goals. Working with our government partners in the U.S. and abroad is important in making sure that implementation is successful. This trip was the last of these journeys, and it was a great experience. 

Why is a partnership with Mexico important? Because it is one of the United States’ top trading partners. A lot of the produce we eat in the U.S. is grown there, including fruits and vegetables that would otherwise be hard to find in the winter months. 

What we learned in meetings with SENASICA and COFEPRIS – two key food safety agencies in the Mexican government – is that we’re all on the same page when it comes to food safety. We share with Enrique Sanchez Cruz, director general of SENASICA, Mikel Arriola, federal commissioner of COFEPRIS, and their able staffs a commitment to protect our citizens from the contaminated foods that cause so many preventable illnesses each year. 

And there is much we can do to help each other. For example, our counterparts in Mexico have a great deal of data to share based on microbiological sampling of foods and inspections. And, like us, they base their food-safety priorities on risk: What are the greatest potential hazards? We came away with a much deeper understanding of their work in this area. 

One of the key messages we got from our Mexican colleagues was that they are eager and committed to working with us to implement FSMA, and this motivates us to take our partnership to a new level. The benefits will be mutual, as FSMA and Mexico’s own food safety initiatives promise to elevate standards and improve practices on both sides of the border. 

At a public listening session on our FSMA proposals attended by representatives of major commodity groups, the sentiments were much the same. They want to be engaged with us in this important work. 

We envision partnerships with our foreign counterparts as being multi-faceted, including data sharing, recognition of inspection reports, multilateral sharing and acceptance of laboratory methods, and training of government and industry on U.S. food safety requirements, and where appropriate, cooperating under trade agreements. 

We know food safety is more a journey than a destination, and the road we are on with Mexico will have its bumps and seem long at times. But, thankfully, we are on the road together, and we will get there. 

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine