Supplements. Supplements. Supplements. These days, it seems like there’s a pill for everything. Want to grow your hair? They’ve got a pill for that. Looking for an alternative to coffee? Take this “all-natural” supplement. Stressed out? How about some CBD? With such a booming market for supplements thanks to a demand for healthier living and the speed of Amazon fulfillment, laws and regulations have been in place to protect consumers from deception. Consider these legal tips from E-commerce attorneys on the best marketing practices so your dietary supplement business can thrive without any legal issues.
Dietary Supplement Legal Tip #1: Don’t Mess with The DSHEA
The Dietary Supplement Health and Education Act (DSHEA) was passed in 1994 to define and regulate dietary supplements. This law is hated by many as some believe it favors dietary supplement manufacturers, allowing for dangerous products to be distributed to consumers without proper testing.
“The deal that DSHEA and NCCAM made with the public was this: Let the supplement industry have free reign to market untested products with unsupported claims, and then we’ll fund reliable studies to arm the public with scientific information so they can make good decisions for themselves. This “experiment” (really just a gift to the supplement industry) has been a dismal failure. The result has been an explosion of the supplement industry flooding the marketplace with useless products and false claims.”
– Steven Paul Novella, prominent skeptic and clinical neurologist
Here are some critical supplement labeling issues to consider before you begin marketing your supplements online. Under the DSHEA, companies marketing dietary supplements are allowed to make two kinds of claims on their labeling. First, companies may make health claims specifically authorized by the Food and Drug Administration (“FDA”), and second, statements of nutritional support. Health claims, such as representations about the product and a disease or health condition, are only allowed if these claims have been authorized by an FDA finding that there is a significant scientific agreement to support that claim. DSHEA requires that these claims on the labeling be substantiated, truthful, and not misleading, which is consistent with the Federal Trade Commission’s standard. The FTC has not only prosecuted the dietary supplement manufacturer, but also the other companies involved in the deceptive promotions.
Other Important DSHEA Points to Consider:
- The legal definition of dietary supplements is “...products taken by mouth that contain a ‘dietary ingredient.’ Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.”
- Tobacco is exempted as a dietary supplement.
- Dietary Supplements must include the following information with the product:
- Ingredients (including amounts)
- Intended Use (must be based on accepted scientific evidence)
- Use Instructions (dosage and ingestion instructions)
- Safety Information (side effects, contraindications, possible reactions and interactions, etc.)
- Company Information (product source, manufacturer and batch info)
- It's important to note that there are different rules that apply to supplements and ingredients released before 1994 and those released after, but variants are too meticulous to include in this article. To ensure your supplements comply to these specific release-date related rules, consult with an experienced attorney who can help.
Dietary Supplement Legal Tip #2: Make Sure Your Suppliers Are Legit
Be sure to verify the legitimacy of your suppliers as if your financial security depends on it, because it may. If you someday hope to make millions with your supplements, vetting your suppliers should be the first step in your business plan. This is because manufacturers from overseas are not required to observe U.S. standards. The hardest part in finding a legit manufacturer is that some foreign suppliers will claim to be compliant with U.S. laws in order to score a job. When this occurs, cost-effective legal resources are scarce, so it is important not to trust a supplier's word and instead, verify it yourself. If you don’t know the best way to avoid shady manufacturers, employ an inspector in the manufacturer's country and have them do on-site visits. It may even be helpful to have a translator – both linguistic and sometimes cultural- so things don’t get lost in translation (literally).
Dietary Supplement Legal Tip #3: Abide by FTC Marketing Regulations
Any product that is marketed to United States consumers will need to be compliant with FTC regulations and guidelines. The FTC’s main goal is to protect consumers from deception. Yes, it is true that the dietary supplement industry is semi-self-regulatory, but brand can’t ignore industry standards, unless they want to face hefty fines. Therefore, marketers have developed multiple dietary supplement disclosures in order to protect against FDA and FTC actions. Below is the most popular disclosure:
“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.”
Before you begin your online advertising and e-commerce campaign for your supplement, be aware of the FTC’s two basic prongs for analyzing a supplement advertisement: (1) the advertisement must be truthful and not misleading; and (2) before advertising, the company must have adequate substantiation for all objective product claims.
Under the first prong, a deceptive advertisement is one that contains a misrepresentation or leaves out an important piece of information that is likely to mislead consumers acting under the circumstances to their detriment. Under the second prong, the FTC bears the burden to successfully prove one of two theories: either, (1) a “falsity theory” proving that the express or implied message conveyed by the ad is false, or (2) a “reasonable basis theory” proving that the advertiser lacked a reasonable basis for asserting that the message true. These supplement advertising laws are not very clear cut, and the lack of FTC compliance can carry significant consequences, including fines, penalties, and even permanent bans.
Dietary Supplement Legal Tip #4: Comply with the FDA In All Marketing and Labeling Efforts.
Supplement businesses need to stay up to date on Food and Drug Administration rulings and decrees because dietary supplement standards are constantly changing. It’s important to always be checking for more banned substances as the list is ever-changing.
Here’s How to Stay Up to Date with the Latest FDA Standards:
- Google Alerts: An easy way to keep up with ingredients contained in your dietary supplement is to set up google alerts for each ingredient. Act as soon as something pops up.
- Consult with a Dietary Supplement Lawyer: An attorney can be your regulatory watchdog and alert you of upcoming changes and may even be able to help optimize your business model to increase your profit potential and asset protection.
- Check the FDA website everyday: A notice is posted to their website whenever the FDA acts so it’s important to check it regularly.
Dietary Supplement Legal Tip #5: Leave Structure-Function Claims to the Professionals
The FTC and your state Attorney Generals are very sensitive about structure-function claims, which are any statements that address how a product affects the body. Examples of structure-function claims include:
- “Collagen makes your hair grow”
- “[insert product name] helps reduce inflammation”
- “[insert product name] minimizes cancer”
- “[insert weight loss product name] will naturally suppress your appetite”
It’s very important to have an attorney audit your marketing campaigns if they include structure function claims. This will help your supplement company avoid huge fines or even a lawsuit for “unfair and deceptive marketing”.
The first place we generally look are the claims on product labels. Your supplement labels may: (1) claim “a benefit related to a classical nutrient deficiency disease,”; (2) describe the role of a dietary ingredient in affecting structure or function of the body; (3) describe the documented mechanism of (2), or (4) describe the “general well-being” derived from consuming the product. Structure or Function claims are claims that “describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” and are permitted so long as they are not “disease” claims. Examples of structure/function claims, as found by the United States Court of Appeals for the First Circuit, include: “supports antioxidant health,” “supports heart health,” “supports the immune system,” and “maintain healthy blood vessels.”
It’s important that you know the difference before you begin marketing your supplements. It’s also critical that your social media influencers are aware of the key differences, and that you have an e-commerce lawyer that is familiar with FTC and FDA labeling requirements review your influencer scripts (yes, you should have written, and screened scripts!).
Need to Consult with a Dietary Supplement Attorney? Look no further than RM Warner Law. Our attorneys know what to look for when marketing dietary supplements and using influencers and e-commerce businesses to sell your supplements online. Get in contact today.