The dietary supplement business is booming. Thanks to plug-n-play e-commerce engines like Amazon, folks are flocking to establish foot holes in the niche. But the industry is not without its headaches. Let’s take three minutes to review some legal issues germane to the space.

Dietary Supplement Law Tip #1: Mind The DSHEA

In 1994, after several failed attempts, U.S. politicians passed the Dietary Supplement Health and Education Act. Its purpose? DSHEA legally defines “dietary supplements” and delineates labeling and logistical parameters for the industry.

Why Some People Hate DSHEA

A notoriously controversial law, opponents say it favors dietary supplement manufacturers and allows for dangerous products to hit shelves without sufficient testing.

Important Takeaways from the DSHEA

• Dietary supplement is legally defined as “a product taken by mouth that contains a ‘dietary ingredient’ intended to supplement” one’s nutritional intake. Dietary ingredients may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be packaged as tablets, capsules, softgels, gelcaps, liquids, or powders.
• DESHEA exempts tobacco as a dietary supplement.
• Dietary supplements are categorized as food, except for the purposes of drug definition.
• The following items must be included on dietary supplements:
  1. Ingredients (w/ amounts);
  2. Intended Use (all intended use claims must be based on accepted scientific evidence);
  3. Safety Information (including contraindications, side effects, possible reactions and interactions);
  4. Use Instructions (proper dosage and other ingestion guidance);
  5. Company Information (manufacturer, production source and batch info)
• Different rules apply for ingredients and supplements released before 1994 and those released after, though the variants are too nuanced for this article. If you think your dietary supplement product may have a release-date-related issue, explain your exact situation to an attorney who can point you in the right direction.
• A whole lot of people despise DSHEA because they feel it gives dietary supplement companies carte blanche to endanger the public. On the topics, a famous naysayer famously opined: “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

Dietary Supplement Law Tip #2: Vet Suppliers Like Your Financial Security Depends On It (Because It May)

The first step to dietary supplement millions is vetting. A whole lot of it. Especially when dealing with overseas manufacturers. Remember, a factory in China (or most places outside of the U.S.) is under no obligation to observe U.S. standards.

And here’s the truly tricky part: some foreign suppliers will feign compliance to get a job. When it happens, cost-effective legal resources are few and far between. Bottom line: don’t trust a supplier’s word. Vet, vet, vet!

And here’s the truly tricky part: some foreign suppliers will feign compliance to get a job. When it happens, cost-effective legal resources are few and far between. Bottom line: don’t trust a supplier’s word. Vet, vet, vet!

So, how do you dodge shady manufacturers? If possible, hook up with an inspector in the manufacturing country. Have him or her do on-site visits; boots-on-the-ground due diligence. Moreover, it’s a plus to have a “translator” on your side. After all, as they say, a lot is lost in translation — both linguistically and sometimes culturally.

Dietary Supplement Law Tip #3: Comply With FTC Marketing Regulations

Think of the Federal Trade Commission as America’s consumer watchdog. If you market to U.S. residents, you’re beholden to FTC regulations and guidelines.

And though the dietary supplement industry is semi-self-regulatory, brands can’t ignore industry standards. To that end, marketers have developed various dietary supplement disclosures to protect against FDA and FTC actions, the most popular being:

“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.”

Dietary Supplement Law Tip #4: Comply With FDA Standards

Dietary supplements are ingestibles, which means sellers must keep up-to-date on Food and Drug Administration rulings and decrees. Maintaining can be difficult because the list of banned substances is ever-changing.

To avoid an FDA action, keep up-to-date with the latest standards. How?

• Set up Google alerts for ingredients contained in your dietary supplements; spend a half hour a day reading through them. If something pops up, take action ASAP.
• Partner with a dietary supplement lawyer. He or she can be your regulatory watchdog and alert you of upcoming changes. Moreover, attorneys may be able to help tweak your business model to increase your profit potential (and asset protection).
• Take 2 minutes a day to check out the FDA’s website. Whenever the agency takes action, a notice is posted online.

Dietary Supplement Law Tip #5: Consult Professionals About Structure-Function Claims

The FTC and Attorneys General — a.k.a., the people who can sue for “unfair and deceptive marketing” — are super sensitive about structure-function claims. So, what’s a structure-function claim, you ask? Basically, it’s any statement that addresses how a product affects the body. Classic structure-function claims include:

1. “Calcium builds strong bones.”
2. “PRODUCT X helps reduce cancer.”
3. “St. John’s Wort minimizes anxiety.”
4. “WEIGHT LOSS PRODUCT will naturally reduce your appetite.”

Marketing campaigns that include structure-function claims should always be audited by an attorney before launch. Why? Because if you cross the compliance line, you may be saddled with a huge fine.

Who Can I Call With My Dietary Supplement Business Questions?

Kelly Warner helps clients overcome e-commerce issues. We’re a team of top-rated attorneys, techs and marketing aficionados who’ve assisted scores of online sellers with everything from FTC compliance to listing hijackings. Head here to the online marketing / e-commerce law section of our website. If you’re ready to speak with a dietary supplement law fixer, get in touch today.