Myth or Fact: Are Vaginal Suppositories Dietary Supplements?
When I started in the dietary supplement industry over 40 years ago, the only delivery forms for dietary supplements were tablets, capsules, softgels, and powders. Nowadays, there are also gummies, melts, liquids, bars, and a variety of functional food confectionaries (e.g., chocolate).
But what about other less common delivery forms offered by some companies within the industry? For example, what about vaginal suppositories? Are they a recognized delivery form that is lawful for use as such?
Continue to read this article or listen to my podcast episode (click below) to learn if vaginal suppositories are dietary supplements or not:
What is the Meaning of a Dietary Supplement?
In answering this question, let’s start with the dietary supplement definition created by the FDA[i]:
Dietary supplements are defined, in part, as products (other than tobacco) intended to supplement the diet that bears or contain one or more of the following dietary ingredients:
- A vitamin;
- A mineral;
- An herb or other botanical;
- An amino acid;
- A dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
- A concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned above.
Further, dietary supplements are products intended for ingestion, are not represented for use as a conventional food or as a sole item of a meal or the diet, and are labeled as dietary supplements.
Most people in the industry are familiar with this dietary supplement definition—at least with the parts of the definition up through number 6 above. But not everyone is clear on the next part listed above, which states, “Further, dietary supplements are products intended for ingestion…”.
To be clear, under Section 201(ff)(2)(A) of the Federal Food, Drug and Cosmetic Act, dietary supplements—which are technically regulated as a food product, not a pharmaceutical—must be “ingested” via an oral route.
The FDA’s position
I remember back in the 1980s when an intranasal gel delivery system was marketed for use as a vitamin B12 dietary supplement. Even then—before the Dietary Supplement Health and Education Act of 1994 when a dietary supplement was properly defined—the FDA sent a warning letter, and the brand had to discontinue the product. From my perspective, this was the appropriate action to take since I was unaware of any long-term safety studies on using intranasal gels to deliver vitamins.
Now, in the past two decades, the FDA has sent many warning letters to dietary supplement company brand owners marketing products that failed the standard of 201(FF)(2)(A). This includes eye drops, nose drops, anti-fungal sprays, topical ointment, and vaginally based treatments (including vaginal suppositories like vaginal probiotic suppositories) being marketed as dietary supplements.
Furthermore, the FDA stated: “We note that only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucosal tissues [including the vagina], such as transdermal products, are not dietary supplements. For such products, both disease and structure/function claims may cause them to be new drugs.”[ii]
This is unambiguous. The FDA has made its position clear. A vaginal suppository is not a dietary supplement, and so cannot lawfully be marketed as such.
Non-dietary Supplement Vaginal Suppositories
Now, just because a vaginal suppository cannot be marketed as a dietary supplement, that doesn’t mean that other categories of vaginal suppositories aren’t allowed. Some vaginal suppositories are medications that help treat fungal infections and vaginal dryness. Likewise, another type is a vaginal contraceptive suppository used by some people as a form of birth control. These types of suppositories will take varying lengths of time to work, depending on their purpose. The size and chemical makeup of a suppository will also determine the rate at which it dissolves.
Conclusion
As a brand owner, it may be tempting to market vaginal suppositories, transdermal patches, and other products intended to enter the body directly through the skin or mucosal tissues as dietary supplements. Don’t do it if you want to avoid a warning letter from the FDA for this violation of the regulations. Remember, dietary supplements must be in a delivery form ingested via an oral route (i.e., your mouth). And the definition of suppository states that it is a dosage form inserted into a body orifice that dissolves or melts to distribute medication and has local or systemic effects, making it a big no-no. However, you still have plenty of other delivery forms to choose from that comply with industry standards.
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References:
[i] Dietary Supplement Labeling Guide: Chapter I. General Dietary Supplement Labeling. U.S. Food & Drug Administration. April 2005.
[ii] Gaffney A. What's a Dietary Supplement? Definition of 'Ingestion' Continues to Lead to Warning Letters. Regulatory Focus. 06 June 2013.
