The U.S. Food and Drug Administration yesterday requested a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules, illegal drug products that contain potentially harmful, undeclared ingredients. The products, often advertised as ``all natural'' alternatives to approved erectile dysfunction drugs, could interact with medications and cause dangerously low blood pressure. They contain substances that have similar structures to active ingredients in approved prescription drugs.

The FDA has not approved True Man or Energy Max, and their safety and effectiveness are unknown.

The FDA requested the recall of all products distributed under both labels in a letter to Yin Kao, president and owner of America True Man Health Inc., of West Covina, Calif.

The products are often advertised in newspapers, retail stores, and on the Internet.

“The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure," said Janet Woodcock, M.D., deputy commissioner for scientific and medical programs, chief medical officer and acting director of the FDA’s Center for Drug Evaluation and Research.

As formulated, True Man Sexual Energy and Energy Max are classified as unapproved new drugs that do not declare the active ingredients thione, an analog of sildenafil; or piperadino vardenafil, an analog of vardenafil. Analogs may cause side effects and drug interactions similar to the approved drugs they resemble.

The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

The FDA issued an alert on May 10, 2007, (http://www.fda.gov/bbs/topics/NEWS/2007/NEW01633.html) advising consumers not to buy or use True Man or Energy Max products. Today’s recall request comes as a result of the company previously failing to notify all of their consignees and involves True Man Sexual Energy packaged in blister pack cartons of 10 capsules and Energy Max packaged in blister pack cartons of 20 capsules. FDA is prepared to take further regulatory action should the firm refuse to accede to this request.

FDA chemical analysis has shown that Energy Max contains thione, an analog of sildenafil, a substance similar to the active ingredient in the approved ED drug Viagra. In addition, FDA investigators found that True Man contains the same analog or an analog of vardenafil, the active ingredient Levitra, another approved ED treatment. Neither of the analogs used in True Man or Energy Max are components of FDA-approved drug products.

Customers who have either product in their possession should stop using it immediately and contact their health care provider if they have experienced any problems that may be related to taking this product.

The U.S. Food and Drug Administration (FDA) today announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.

FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.

There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.

Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.

Two weeks ago, FDA was notified that researchers with the Ottawa Health Institute stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The preliminary data from this terminated study also suggested that fewer patients receiving the drug experienced serious bleeding events.

On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to the Canadian study's termination. In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.

The U.S. Food and Drug Administration has selected 15 voting members to serve on its Risk Communication Advisory Committee. The Committee will advise FDA about how best to communicate to the public about the risks and benefits of FDA-regulated products so as to facilitate their optimal use.

On June 5, 2007 FDA announced the establishment of the advisory committee and requested nominations for qualified individuals to serve as members. The agency received more than 240 nominations, many for exceptionally qualified individuals.

The establishment of the advisory committee was one of the recommendations of the Institute of Medicine’s 2006 report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public."

"Communicating effectively about the safety and effectiveness of drugs and other medical products is one of the central roles of FDA," said Randall Lutter, Ph.D., Deputy Commissioner for Policy. "We were in such strong agreement about the value of the Risk Communication Advisory Committee that we expanded its scope to address communication regarding all products regulated by the agency, including our food supply responsibilities."

The advisory committee’s 15 voting members include independent experts and public members. Experts were chosen from the fields of risk communication, risk perception, decision analysis, communication, social marketing, health literacy, journalism, and other behavioral and social sciences. Public members include those who can provide the perspective of users of FDA-regulated products, such as consumers, patients, caregivers and health care providers. For some meetings, one or more industry representatives may be invited to participate in a nonvoting capacity.

Members have been assigned to serve for periods ranging from one to four years. FDA expects to hold the committee’s first meeting in the first quarter of 2008. The list of members is available on FDA’s Web site at http://www.fda.gov/oc/advisory/OCRCACRoster.htm.

FDA is currently amending the committee’s charter to incorporate the provisions of the recently passed Food and Drug Administration Amendments Act of 2007.

The U.S. Food and Drug Administration today approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with chronic kidney failure.

The labeling changes, which incorporate advice from FDA advisory committees and expand upon labeling changes made in March 2007, also include a statement that symptoms of anemia, fatigue and quality of life have not been shown to improve in patients with cancer who are treated with ESAs.

Epogen, Procrit and Aranesp are approved to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in certain patients with cancer. Epogen and Procrit are also approved for use in certain patients with anemia who are scheduled to undergo major surgery to reduce blood transfusions during or shortly after surgery and for the treatment of anemia caused by zidovudine (AZT) therapy in HIV patients.

For Patients with Cancer
For patients with cancer, the new boxed warnings emphasize that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater.

The boxed warnings also emphasize that no clinical data are available to determine whether there is a similar risk of shortened survival or increased tumor growth for patients with cancer who receive an ESA dose that attempts to achieve a hemoglobin level of less than 12 g/dL. This is the hemoglobin level commonly achieved in clinical practice.

Health care providers determine whether a patient is anemic and decide on ESA dosing by measuring how much of the protein known as hemoglobin is present in a patient's red blood cells.

An earlier boxed warning, approved in March, described the results of six studies demonstrating that survival was shorter and tumors progressed faster when ESAs were used to achieve hemoglobin levels of 12 g/dL or greater in cancer patients.

Today's new boxed warning also clarifies that ESAs should only be used in patients with cancer when treating anemia specifically caused by chemotherapy and not for other causes of anemia. Moreover, it states that ESAs should be discontinued once the patient's chemotherapy course has been completed.

"Health care professionals need to consider the risks of increased tumor progression and decreased survival in patients with cancer when prescribing ESAs," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer and acting director of its Center for Drug Evaluation and Research. "ESAs should be used in patients with cancer only when their anemia is due to chemotherapy and only at the lowest dose necessary to avoid the need for blood transfusions."

The FDA is working with the manufacturer to design and conduct clinical trials of different dosing regimens and tumor types to further characterize potential tumor progression associated with ESAs.

For Patients with Chronic Kidney Failure
For patients with chronic kidney failure, the new boxed warning states that ESAs should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk for death and for serious cardiovascular reactions such as stroke, heart attack or heart failure, the boxed warning states.

In addition to the boxed warning, the new labeling provides specific instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment with an adequate increase in their hemoglobin levels.

The new labeling also emphasizes that there are no data from controlled trials demonstrating that ESAs improve symptoms of anemia, quality of life, fatigue, or patient well-being for patients with cancer or for patients with HIV undergoing AZT therapy.

In March 2007 the FDA approved labeling changes and issued a public health advisory outlining the new safety information about ESAs. Safety concerns regarding ESAs were discussed during May 2004 and May 2007 meetings of FDA's Oncologic Drug Advisory Committee and a September 2007 joint meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. ESA product labeling was previously revised in 1997, 2004 and 2005 to reflect new safety information.

The agency is currently reviewing a proposed Medication Guide that will better communicate the safety and effectiveness of ESAs to patients and will replace the existing patient labeling.

ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. These drugs are manufactured by Amgen Inc., Thousand Oaks, Calif. Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, N.J, a subsidiary of Johnson & Johnson.

For more information: http://www.fda.gov/cder/drug/infopage/RHE/default.htm

Reduces Risk of Pneumonia for Patients Using Ventilators
The U.S. Food and Drug Administration today announced that it has cleared for marketing a breathing tube coated with a thin layer of silver. The coating, a material known to have antimicrobial properties, reduces the risk that patients on ventilators will acquire pneumonia while in the hospital.

The Agento endotracheal tube, manufactured by C.R. Bard Inc., is intended for patients who must rely on a ventilator to breathe for 24 hours or more.

Patients requiring such a breathing support system are at risk of exposure to hospital-acquired bacteria that can build up on the breathing tube or pass through the tube to their lungs, eventually causing a lung infection known as ventilator-associated pneumonia (VAP).

Fifteen percent of the patients on ventilators develop VAP every year and 26,000 die from the infection, according to the Centers for Disease Control and Prevention.

"Patients who require ventilator support are at increased risk for pneumonia, which poses a significant public health issue. This product can help to lower this risk," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health.

Silver has been known for its antimicrobial properties for decades and has been used for this purpose on several types of devices. This is the first endotracheal tube coated with silver.  

In a multicenter clinical trial comparing the Agento breathing tube to an uncoated tube, the percentage of patients who developed pneumonia was reduced from 7.5 percent to 4.8 percent. The Agento also delayed the onset of pneumonia.

The FDA in July issued a proposed guidance document on antimicrobial device submissions stating that when companies claim their product reduces or prevents device-related infections, the claim should be supported by such clinical data.

C.R. Bard is located in Murray Hill, N.J.

The Food and Drug Administration (FDA) has approved Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg), an allergy drug, for nonprescription use in adults and children 12 years of age and older. This drug combines an antihistamine with a nasal decongestant.

Available as a prescription drug since 2001, Zyrtec-D is now approved as a nonprescription drug for the relief of symptoms due to hay fever or other upper respiratory allergies such as, runny nose, sneezing, itchy, watery eyes, itching of the nose or throat, and nasal congestion. Zyrtec-D is also for reducing swelling of nasal passages, for relief of sinus congestion and pressure, and for restoring freer breathing through the nose.

Hay fever and other allergies are the sixth leading cause of chronic disease, with about 50 million sufferers each year in the United States, according to the National Institute of Allergy and Infectious Diseases.

"The approval of this widely-used drug for nonprescription use will enable many people to have access to another effective treatment for their allergy symptoms," said Andrea Leonard-Segal, M.D., director, Division of Nonprescription Clinical Evaluation in the FDA"s Center for Drug Evaluation and Research. "This approval reflects FDA's commitment to bringing prescription drugs to the over-the-counter market when they can be safely used without a prescription.

Zyrtec-D"s common side effects include drowsiness, fatigue, and dry mouth. Sales of the drug are subject to restrictions in the Combat Methamphetamine Epidemic Act. This law places restrictions on the sale of products containing pseudoephedrine, such as limiting the amount that an individual can purchase, and imposing record keeping requirements on the retail establishments that sell the product. Zyrtec-D is distributed by McNeil Consumer Healthcare, Fort Washington, Pa.

Agency says drug to remain on market, while safety assessment continues
The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks.

People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.

"FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "FDA remains committed to making sure that doctors and patients have the latest information about the risks and benefits of medicines."

Avandia, manufactured by GlaxoSmithKline (GSK), Philadelphia, Pa., was approved in 1999 as an adjunct to diet and exercise to improve control of blood sugar levels. Avandia is approved to be used as a single therapy or used in combination with metformin and sulfonylureas, other oral anti-diabetes treatments.

During the past year, FDA has carefully weighed several complex sources of data, some which show conflicting results, related to the risk of chest pain, heart attacks and heart-related deaths, and deaths from any cause in patients treated with Avandia.

At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Therefore, FDA has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent. GSK has agreed to conduct the study and FDA will ensure it is initiated promptly.

The revision of Avandia's existing boxed warning – FDA's strongest form of warning – includes the following statement:

A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.

The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients.
GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia.

To date, no oral anti-diabetes drug has been conclusively shown to reduce cardiovascular risk. Consequently, the agency also will be requesting that labeling of all approved oral anti-diabetes drugs contain language describing the lack of data showing this benefit.

Today's action follows recommendations made at the July 2007 joint meeting of FDA's Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling.

For more information:
Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm

FDA Issues Safety Alert on Avandia
www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html

The Food and Drug Administration is announcing several steps to strengthen its advisory committee processes in ways consistent with recommendations of the Institute of Medicine. The measures include proposed new guidance or procedures on advisory committee voting, on disclosing information on conflicts of interest, and on security and appropriate conduct for participants at meetings. Other improvements include greater clarity to FDA’s advisory committee Web site, which can be found at http://www.fda.gov/oc/advisory/default.htm.

“One of FDA’s strengths is that we routinely enlist the nation’s leading experts to give us public advice on complex medical and scientific issues,” said Randall Lutter, Ph.D., deputy commissioner for policy. “The new steps we’re taking further enhance the transparency and reliability of our advisory committee processes.”

A draft guidance document being issued today recommends advisory committees adhere to a process of simultaneous voting, in which all members vote at once. The results of the vote would be announced immediately. How each member voted would be part of the public record. The draft guidance document is available at http://www.fda.gov/oc/advisory/votingguidance.html.

A second draft guidance issued recently lays out recommended changes to the process of public disclosure of financial interests that create conflicts of interest for advisory committee members. The new draft guidance makes the process more transparent and consistent by having all advisory committee members publicly disclose interests for which a waiver is granted. The draft guidance also includes redesigned disclosure and waiver templates that are clearer and easier for the general public to understand. The draft guidance document and redesigned templates are available at http://www.fda.gov/oc/advisory/waiver/ACdisclosure1007.html.

FDA also has formalized operating procedures designed to ensure appropriate security and promote proper decorum and public conduct at advisory committee meetings. They are intended to help ensure that meetings proceed in an orderly fashion and that the work of the committees is not impeded, but that the right of free speech is also protected.

In addition, FDA has improved its Web page on advisory committees by providing better access to information about waivers granted for conflicts of interest. This Web page provides current information about upcoming advisory committee meetings and other updated information related to FDA's advisory committee processes. The Web site is at http://www.fda.gov/oc/advisory/default.htm.

Finally, the FDA has recently posted the names of outside experts that it has named to a new risk communication advisory committee to make recommendations to FDA about how best to communicate the risks and benefits of FDA regulated products. More information about this advisory committee and the list of members can be found at http://www.fda.gov/bbs/topics/NEWS/2007/NEW01739.html.

FDA’s policies on advisory committees continue to be informed by new studies on conflicts of interest. The agency asked a consultant, Eastern Research Group, to study 16 recent advisory committees. The report highlights the difficulty of assembling highly qualified experts who are free of conflicts and finds that those who have received waivers appear to be significantly more qualified than those who have not received waivers. The full report is available online at http://www.fda.gov/oc/advisory/ERGCOIreport.pdf.

So far this year the agency has convened 47 meetings of expert independent advisory committees to advise FDA on topics such as new gene therapies and the safety of children’s cough and cold medicines.

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The U.S. Food and Drug Administration (FDA) today announced the board members and chair of the Reagan-Udall Foundation. The private and independent nonprofit organization will advance FDA's mission to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.

"The Reagan-Udall Foundation will be an important and independent vehicle for furthering the mission of FDA. By supporting public-private partnerships and other scientific collaborations, the foundation will enrich the agency and provide critical perspectives for the future," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "As FDA looks toward its future, the Reagan-Udall Foundation is in a unique position to understand, support and prepare the agency for that future."

"This foundation brings together an extraordinary group of leaders with diverse talents and experiences. The board members' combined backgrounds reflect the transformation and vision of FDA," said von Eschenbach.

In a demonstration of bipartisan support, the U.S. Congress mandated the foundation's creation in the Food and Drug Administration Amendments Act, passed in September 2007. The law requires that the foundation board of directors be established within 30 days and that it not include any federal employee.

Mark McClellan, M.D., Ph.D., director of the Engleberg Center for Health Care Reform at the Brookings Institution, former commissioner of FDA and former administrator of the Centers for Medicare and Medicaid Services, will chair the foundation.

McClellan said, "The foundation is an unprecedented opportunity to enlist broad-based support to accelerate scientific progress to help FDA fulfill its mission of protecting and promoting the public health—a mission that is more challenging but more important than ever."

"I look forward to a collaborative partnership with the board, the agency, legislators, and stakeholders to accelerate innovation that will improve the quality and safety of medical and food products," said McClellan.

In addition to McClellan, the new board members are:

Georges C. Benjamin, M.D.
Executive Director, American Public Health Association
William Brody
President, The Johns Hopkins University
Helen Darling
President, National Business Group on Health
Cal Dooley
President and CEO, Grocery Manufacturers Association
Michael Doyle, Ph.D.
Regents Professor and Director, Center for Food Safety, University of Georgia
Joseph M. Hogan
President and CEO, GE Healthcare
Kay Holcombe
Senior Health Policy Advisory, Genzyme Corporation
Sharon Levine, M.D.
Associate Executive Medical Director, The Permanente Medical Group
Gary Neil, M.D.
Group President, Johnson & Johnson Pharmaceutical Research & Development
Phillip A. Sharp, Ph.D.
Institute Professor, Center for Cancer Research, Massachusetts Institute of Technology
Ellen V. Sigal, Ph.D.
Chair and Founder, Friends of Cancer Research
Tadataka Yamada, M.D.
President, Global Health Program, Bill & Melinda Gates Foundation
Diana Zuckerman, Ph.D.
President, National Research Center for Women and Families
"By agreeing to serve on the board, these distinguished representatives will help FDA continue to bridge scientific discovery into the development of safe and effective products," said von Eschenbach. "They reflect the areas served by FDA, all of which have a stake in a transparent and collaborative process. The broad representation from science, academia and industry in addition to strong Congressional support for this foundation is indicative of its mission, which will be about building the science of product safety."

The statute calls for a 14-member board: four representatives from the general pharmaceutical, device, food, cosmetic, and biotechnology industries; three from academic research organizations; two from patient or consumer advocacy groups; one representing health care providers; and four at-large representatives with expertise or experience relevant to the foundation's purpose.

In addition, a majority of the foundation's board members—nine out of 14—must be appointed from a list of candidates provided by the National Academy of Sciences and the remaining five from nominations submitted by patient and consumer advocacy groups, professional scientific and medical societies and industry trade organizations.

As required by statute, four government health care officials—the commissioner of the FDA, the director of the National Institutes of Health, the director of the Centers for Disease Control and Prevention, and the director of the Agency for Health Care Research and Quality—appointed the board members from the two lists of candidates. The FDA commissioner and NIH director will continue participating in foundation activities as non-voting board members.

Congress established the Reagan-Udall Foundation to identify and address unmet scientific needs in the development, manufacture and evaluation of the safety and effectiveness of FDA-regulated products, including post-market evaluation. The foundation will establish scientific projects and programs to address those needs and help accomplish the scientific work FDA needs to support its regulatory mission.

Product contains drug ingredient, makes unapproved drug claims, could damage eye
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized today 12,682 applicator tubes of Age Intervention Eyelash, a product that may, in some users, lead to decreased vision. Authorities said the sales value of the seized tubes is approximately $2 million.

Age Intervention Eyelash is sold and distributed by Jan Marini Skin Research, Inc., of San Jose, Calif.

The FDA considers Age Intervention Eyelash to be an unapproved and misbranded drug because Jan Marini Skin Research has promoted the product to increase eyelash growth. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA. The agency takes seriously its responsibility to protect Americans from unapproved drugs.

FDA also considers the seized Age Intervention Eyelash to be an adulterated cosmetic. The product contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye).

For patients using the prescription drug, using the Age Intervention Eyelash in addition to the drug may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug's effectiveness. Damage to the optic nerve may lead to decreased vision and possibly blindness.

In addition, use of Age Intervention Eyelash may cause other adverse effects in certain people due to the bimatoprost, including macular edema (swelling of the retina) and uveitis (inflammation in the eye), which may lead to decreased vision.

The U.S. Attorney's Office for the Northern District of California filed the complaint requesting the seizure, and coordinated with the FDA. The California Department of Public Health‘s Food and Drug Branch had previously embargoed the seized products at the San Jose facility. Jan Marini Skin Research has notified FDA that the company ceased manufacturing and shipping any Age Intervention Eyelash product containing bimatoprost last year.

The FDA recommends that consumers, dermatologists, and estheticians who may still have Age Intervention Eyelash discontinue using it and discard any remaining product. FDA also recommends that consumers consult their health care provider if they have experienced any adverse events that they suspect are related to the product's use.