FDA Issues Warning to Bayer HealthCare for Marketing Unapproved Drugs

The U.S. Food and Drug Administration has sent warning letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products--Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).

The products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be legally marketed.

In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease. Bayer Women's is also labeled for use in "fighting" osteoporosis. Neither product has been approved by FDA for such uses. These drug uses require a health care professional's diagnosis and supervision, and therefore these products cannot be labeled for use by consumers and sold over-the-counter (OTC).

"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process," said Mike Chappell, FDA's acting associate commissioner for regulatory affairs. "The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process."

Bayer Heart Advantage combines aspirin and phytosterols in a single tablet. Bayer Women's combines aspirin and calcium carbonate in a single tablet. The products are labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug.

According to the labeling, the phytosterols in Bayer Heart Advantage are intended to lower blood cholesterol and the calcium in Bayer Women's is intended to strengthen bones to fight osteoporosis. Although certain calcium-containing dietary supplements may bear claims to reduce the risk of osteoporosis, products that are labeled to "fight" or otherwise treat osteoporosis are drugs that require FDA approval.

Similarly, although certain phytosterol-containing dietary supplements may bear claims to reduce the risk of coronary heart disease, and may note that the mechanism by which phytosterols achieve this effect is through lowering blood cholesterol, direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and hypercholesterolemia, which is also a disease. Products bearing such claims require an approved new drug application from FDA in order to be legally marketed, and cannot be legally marketed for OTC use.

In addition, Bayer Heart Advantage and Bayer Women's are misbranded because their labeling lacks adequate directions for use by consumers. In order for a drug to have adequate directions for use, the directions must be written so that consumers can use the product safely for its intended purpose, without the supervision of a health care professional. The use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use. Therefore, it is not possible, in OTC drug product labeling, for these products to have adequate directions for their intended uses.

The products also are misbranded because their labeling do not have adequate warnings and are misleading. Among other things, the labeling for the aspirin in the products includes directions and warnings regarding short term use, but these directions and warnings are contradicted by other directions for the phytosterols and calcium that promote the products' daily use without any time limits. The result is a mixed message about the products' purposes and the length of time for which the products can be safely used.

Download Center

HTML - No Current Item Deck
  • Safety Management Software - Free Demo

    IndustrySafe Safety Software’s comprehensive suite of modules help organizations to record and manage incidents, inspections, hazards, behavior based safety observations, and much more. Improve safety with an easy to use tool for tracking, notifying and reporting on key safety data.

  • Create Flexible Safety Dashboards

    IndustrySafe’s Dashboard Module allows organizations allows you to easily create and view safety KPIs to help you make informed business decisions. Our best of breed default indicators can also save you valuable time and effort in monitoring safety metrics.

  • Schedule and Record Observations

    IndustrySafe's Observations module allows managers, supervisors, and employees to conduct observations on employees involved in safety critical behavior. IndustrySafe’s pre-built BBS checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Why Is Near Miss Reporting Important?

    A near miss is an accident that's waiting to happen. Learn how to investigate these close calls and prevent more serious incidents from occurring in the future.

  • Get the Ultimate Guide to Safety Training

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common FAQs.

  • Industry Safe
comments powered by Disqus

OH&S Digital Edition

  • OHS Magazine Digital Edition - June 2019

    June 2019

    Featuring:

    • ASSP SAFETY 2019 PREVIEW
      New Orleans Networking
    • NATION SAFETY MONTH
      Heed These Summer Safety Tips
    • TRAINING
      Education, Skill Development, and Behavior Change
    • SAFETY MANAGEMENT
      What Good Looks Like
    View This Issue

Bulwark Quiz