The Importance of Having a Regulatory Partner
For every dietary supplement product launched, brands must maintain a keen eye toward compliance, especially with the FDA, the FTC and the class action bar—which is all the more reason to have a strong regulatory partner at your side.
From quality issues to COVID-19, regulatory challenges are constantly evolving:
Claims that are normally allowed for dietary supplements (e.g., “Maintain a healthy immune system”) become disease claims if you imply that the benefit is somehow tied to prevention or treatment of a disease, such as COVID-19.
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The FTC, on its own or in conjunction with the FDA, has sent almost 500 warning letters about COVID-19 claims alone.
Regulated consumer products constitute a burgeoning market. Dietary supplements and functional foods alone account for more than $15 billion per year in sales.
$15 billion
Understanding the Federal Food, Drug, and Cosmetic Act (FD&C Act)
What is DSHEA?
The FD&C Act is the FDA’s main authorizing statute and sets requirements for the manufacture, packaging, storage and shipment of regulated products in interstate commerce.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 is the FDA’s means to regulate ingredients and finished dietary supplement products and monitor for misbranded or adulterated product.
Having a regulatory partner that can provide customized end-to-end solutions that address a brand’s unique needs provides the foundation necessary for a brand to succeed and the ability to respond quickly should market forces cause challenges to arise. While there are common pitfalls brands need to avoid, such as the effects of climate change, COVID-19 or the volatility of hemp legislation, new challenges are constantly arising. A regulatory partner can be key to protecting a product at any stage and, ultimately, profit.
Know how to protect your product and profit
How to market effectively in a competitive landscape
Choose a partner
in protection
Venable structures and negotiates licenses, research contracts and technology transfer agreements. Protecting trade secrets, patents, trademarks and copyrights is Venable’s strong suit.
Success requires aggressive marketing, which can raise legal challenges. Venable attorneys can help assess campaign risks—including claims, substantiation, NAD challenges and the potential for class action litigation.
Venable has years of experience dealing with challenges at every stage, from gaining FDA approvals or managing adverse event reports to challenges before the FTC, NAD and state AGs or defending a brand in consumer litigation.
What’s at Stake?
An Investment Worth Making
The right regulatory partner is an investment in protecting your product and profit
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PAID CONTent
Dietary supplement brands and products face fierce competition for the attention of today’s consumers. Yet, before a quality product can even get to the shelf, it has to navigate the ins and outs of regulatory compliance across the product life cycle—from product development and regulatory approval and clearance, to advertising, marketing and distribution. Having the right regulatory partner can be critical to a brand’s success.
The U.S. Food & Drug Administration (FDA) holds primary responsibility for ensuring the safety of foods and dietary supplements (among other categories) in the United States. It sets requirements for labeling under the Fair Packaging and Labeling Act (FPLA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act) and all other requirements applicable to regulated products.
The Federal Trade Commission (FTC) has authority over advertising for dietary supplements and food and beverage products under the Federal Trade Commission Act.
State attorney general (AG) enforcement authority is derived from Unfair and Deceptive Acts and Practices (UDAP) statutes and is similar to that of the FTC.
Know Your Regulators
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