Not unlike the term “natural,” defining what “Made in the USA” actually means for dietary supplements can prove a tad challenging. As long as the global marketplace continues to become more connected and products manufactured on American soil continue to incorporate ingredients and supplies sourced from around the world – the discussion concerning what actually defines a dietary supplement product as “Made in the USA” is likely to continue.

News Spotlight: deMedicis v. CVS Health Corp. et al

Most recently, the “Made in America” discussion was pushed back into the spotlight thanks to a class action suit filed by an Illinois resident claiming that the presence of “Made in the US” on certain supplement products sold by CVS was deliberately misleading.

Though the case was ultimately dismissed late last week, it looks like like the conversation surrounding this particular claim may not be leaving the public sphere any time soon.

Major industry news outlets have noted that this particular case may open the door for other class action suits concerning claims that have been recognized for being equally ambiguous including “pharmaceutical grade” and “clinically proven.”

What it means for a supplement to be “Made in the USA”

Like we’ve covered in the past, it can prove somewhat difficult to track down a concise or official definition for “Made in the USA” that can be applied to dietary supplements.

That said, one of the most complete and authoritative definitions out there happens to be the one provided by the Federal Trade Commission (FTC). As per the official FTC website, the parameters for “Made in the USA” are as follows:

For a product to be called Made in USA, or claimed to be of domestic origin without qualifications or limits on the claim, the product must be “all or virtually all” made in the U.S. The term “United States,” as referred to in the Enforcement Policy Statement, includes the 50 states, the District of Columbia, and the U.S. territories and possessions.

The phrase to note here is “all or virtually all.” While technically still on the ambiguous side, the phrase makes clear the majority of the components and ingredients used to manufacture a product should be sourced from within the United States (or one of its territories).

How should I label my dietary supplement product?

Before we get into some of the label claim alternatives that brand owners can consider for their dietary supplement products, please take a moment to consider the following: DISCLAIMER – This blog only provides helpful information and does not provide legal or regulatory advice. Users are encouraged to seek professional assistance if they are concerned about a specific legal or regulatory issue.

Now that we’ve gotten out of the way…

Some popular label alternatives have come to include:

  • Made in America
  • Assembled/Manufactured in America
  • Made with American Materials
  • American Brand

For most dietary supplement brands and manufacturers, “Assemble/Manufactured in America” tends to be one of the more viable options. Because so many supplement ingredients can (and often times are) supplied by international sources – opting for a “assembled/manufactured” claim tends to have the best potential for providing customers with an accurate understanding of the circumstances under which a dietary supplement product was manufactured. 

The Future of “Made in the USA”

We’re curious to see if the “Made in theUSA” discussion earns a place as one of 2017’s most significant regulatory conversations.

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