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INSIGHTS

Your Marketing Team Created a Viral Claim. Did They Also Create an FDA Enforcement Risk?

Every marketing team wants the same thing:

More views. More clicks. More shares. More sales.

And sometimes, a little too much enthusiasm.

A supplement that “supports wellness” suddenly “reverses disease.” A cosmetic that “improves the appearance of wrinkles” becomes a product that “rebuilds collagen and repairs damaged skin.” A beverage that “helps you stay hydrated” becomes “the cure for exhaustion.”

Congratulations.

Your product just went viral.

It may have also just entered a completely different regulatory category.

In the Eyes of FDA, Claims Matter

FDA does not regulate products based only on what they are made of.

It also evaluates what companies say products do.

The same bottle, jar, capsule, or can may be regulated very differently depending on:

  • Label claims;
  • Website statements;
  • Social media content;
  • Influencer statements;
  • Testimonials;
  • Images and implied claims.

The phrase “our marketing intern wrote it” has never appeared in the Federal Food, Drug, and Cosmetic Act as a legal defense.

(We checked.)

The New Compliance Frontier: Social Media

Modern regulatory reviews extend far beyond product labels.

Companies should regularly evaluate:

  • TikTok and Instagram videos;
  • Influencer partnerships;
  • Affiliate marketing;
  • Customer testimonials;
  • Before-and-after photographs;
  • Hashtags and campaign language.

A single problematic post can be screenshot, shared, and preserved long after it has been deleted.

The internet has an excellent memory.

Unfortunately, it does not offer a delete button for regulatory history.

How Companies Can Protect Themselves

Develop a claims review process involving:

  • Legal and regulatory teams;
  • Marketing teams;
  • Scientific and quality personnel;
  • Influencer guidelines and approval procedures.

Companies should also maintain substantiation files supporting product claims and regularly audit marketing channels.

The goal is not to make your marketing boring.

Nobody has ever purchased a product because the label said, “This item exists.”

The goal is to make compelling, creative claims that are also supported and legally defensible.

The Bottom Line

The most successful brands understand that regulatory strategy and marketing strategy are not enemies.

When legal and creative teams work together early, companies can develop bold campaigns that drive growth while reducing FDA, FTC, competitor, and consumer class action risk.

Before your next campaign goes live, make sure your claims strategy is ready for the same amount of attention your marketing team hopes to receive.

★★★★★

Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
R.G. Client
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Mike H. Client
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
Dr. Sastry Client
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
Claire P. Client

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