--- title: FDA Issues Warning Letters on Combination Dietary Supplement/OTC Drug Products date: 2008-11-12T00:00:00-05:00 author: Import Bot canonical_url: "https://www.kelleydrye.com/viewpoints/client-advisories/fda-issues-warning-letters-on-combination-dietary-supplement-otc-drug-products" section: Client Advisories --- # FDA Issues Warning Letters on Combination Dietary Supplement/OTC Drug Products November 12, 2008 Kelley Drye Client Advisory On October 28, 2008, the Food and Drug Administration (“FDA”) issued two warning letters regarding over-the-counter (“OTC”) products that combine aspirin with a dietary supplement into a single pill. One product combined low-dose aspirin and phytosterols, while the other combined low-dose aspirin with calcium. In the two letters with similar legal arguments, the FDA took the following positions: - The products are unapproved ​“new drugs.” - Because use of the products requires physician supervision, OTC sales are not appropriate. - The products are misbranded. Kelley Drye & Warren’s [Food and Drug](/Our-Practices/Regulatory-Government-Relations/Food-and-Drug-Regulation) Practice Group has prepared the Client Advisory below discussing the FDA’s positions. - Share this entry - - - - - [ View entry pdf ](https://s3.amazonaws.com/cdn.kelleydrye.com/content/uploads/pdf-snapshots/fda-issues-warning-letters-on-combination-dietary-supplement-otc-drug-products-20230913222337.pdf) ### Attachments - [FDA Issues Warning Letters on Combination Dietary Supplement OTC Drug Products](https://s3.amazonaws.com/cdn.kelleydrye.com/content/uploads/attachments/FDA-Issues-Warning-Letters-on-Combination-Dietary-Supplement-OTC-Drug-Products.pdf) ### Related Services - [Dietary Supplements and Functional Foods](https://www.kelleydrye.com/industries/dietary-supplements-and-functional-foods) - [Advertising and Marketing](https://www.kelleydrye.com/practices/advertising-and-marketing) - [Food and Drug](https://www.kelleydrye.com/industries/food-and-drug) Blog [ ![](https://d3iuizmsm2hayf.cloudfront.net/content/uploads/Listing-rectangles/Blog_Post_Listing.svg) ![](https://d3iuizmsm2hayf.cloudfront.net/content/uploads/Listing-Images/adlaw_billboard_listing.webp?auto=compress%2Cformat&crop=focalpoint&fit=crop&fp-x=0.5&fp-y=0.5&h=750&q=80&w=1125&s=e1a7aebcee8115938489d6575321e698) ](https://www.kelleydrye.com/viewpoints/blogs/ad-law-access/nad-continues-to-examine-influencer-campaigns) Ad Law Access July 27, 2026 [ ](https://www.kelleydrye.com/viewpoints/blogs/ad-law-access/nad-continues-to-examine-influencer-campaigns) Blog [ ![](https://d3iuizmsm2hayf.cloudfront.net/content/uploads/Listing-rectangles/Blog_Post_Listing.svg) ![](https://d3iuizmsm2hayf.cloudfront.net/content/uploads/Listing-Images/adlaw_billboard_listing.webp?auto=compress%2Cformat&crop=focalpoint&fit=crop&fp-x=0.5&fp-y=0.5&h=750&q=80&w=1125&s=e1a7aebcee8115938489d6575321e698) ](https://www.kelleydrye.com/viewpoints/blogs/ad-law-access/hawaii-enacts-a-synthetic-performer-law) Ad Law Access July 26, 2026 [ ](https://www.kelleydrye.com/viewpoints/blogs/ad-law-access/hawaii-enacts-a-synthetic-performer-law)