Points to ponder

But I added the disclaimer statement, I am in compliance, right?

You know this one…

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

But did you know this disclaimer text is from the regulations that apply to Dietary Supplements?

Specifically, it is in 21 CFR

PART 101 — FOOD LABELING

Subpart F – Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims

Sec. 101.93 Certain types of statements for dietary supplements.

So, if you decide to market a product with claims that have not been specifically studied and/or reviewed by the FDA for say a device or test kit, you are still not in compliance with FDA regulations. And as such, depending on the extent of your claims and the classification of the product you could be marketing a product without pre-market.

Example FDA Action Language:

“Based on our review, your COVID-19 Test Kits are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19¹ in people, and thus, are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).

Section 201(h) of the FD&C Act (21 USC 321(h)) provides that the term “device” means:

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is–
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”

So if you decide to make these claims without pre-market notification to FDA then you may see this……..

“…have been distributed in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, these products are adulterated within the meaning of section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g)”

So what’s the risk?

1. FDA letter that requires action
2. Required to cease promotion & distribution, potential recalls, fees
3. May be required to recall product and send notices to distributors and customers

What’s the cost?

1. Time
2. Money
3. Negative visibility (publicity)
4. History of non-compliance now known to FDA

Want to launch a product fast, but just do not know how to position it?

Medical Device

Medical Foods

Cosmetics

OTC products

Is it a drug or cosmetic?

If you want an assessment of your currently marketed products and promotion, please reach out for an assessment of adequacy of compliance and claims substantiation.

Contact me directly here!