A Crash Course In Dietary Supplement Law For Online Marketers

dietary supplement law

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.

Dietary Supplement Law: Court Says Re-seller Is Counterfeiter

dietary supplement law
A recent dietary supplement law conflict will likely affect similar cases in the future.

Dietary supplement counterfeit claim news: A judge awarded 5-Hour Energy — an over-the-counter drink sold at Walgreens or CVS — over $20 million dollars after third-party distributors took liberties with the brand’s labeling.

Anyone involved in the sale or marketing of supplements should take 3 minutes to read about this case. It’s serves as a reminder that hyper-aggressive sales tactics can decimate profits.

Dietary Supplement Law: Counterfeit Dispute

5-Hour Energy usually reaches store shelves through re-sellers and third-party marketers. The lawsuit we’re about to discuss involved one such deal that went awry.

In 2009, Living Essentials granted a small California business the exclusive distribution rights for Mexico. New packaging and labels tailored to Spanish-speaking consumers — plus discounted stock options — were all part of the deal.

What went wrong?

Well, according to Living Essentials, the pair initiated a scam that involved:

  • Selling the Spanish-labeled products at higher prices than the English-labeled products, in the United States instead of Mexico;
  • Selling its supply to U.S. distributors who replaced the 5-Hour Energy label with their own brands’ labels.

Did The Distributor Break A Contract By Reselling Products?

Living Essentials (LE) felt their Mexico distribution partners were violating parts of the Lanham Act. As far as LE saw it, the defendants knowingly produced fake goods at Living Essentials’ expense.  The defendants, conversely, insisted that they operated within the contract’s bounds.

And it’s with those viewpoints that the two parties embarked down Lawsuit Lane.

Now, as far as dietary supplements go, 5-Hour Energy is a huge player, so the legal battle fell into the “high-profile” category. And we all know what high profile lawsuits look like: protracted, nuanced and teeming with motions. This particular case lasted four years and involved fastidious vendor investigations, counterfeit-related court orders, and jurisdictional changes; plus, the defendants clawed deep during appeals, involving over 70 different entities.

Court Makes Dietary Supplement Law Ruling: Distributor Didn’t Have Resell Rights

Ultimately, the plaintiffs, Living Essentials, won this dietary supplement counterfeit case. In a 94-page opinion, the court explained how the defendants violated the Lanham Act by running a private label side business that contravened the original distribution contract. Interestingly, the Court also laid blame at the feet of a convenience store that sold the re-branded products and ordered it to pay part of the damages.

Dealing With Dietary Supplement Law Issues?

Our firm helps private label sellers and marketers with dietary supplement law issues. We answer questions, write contracts, help clients defend themselves against FTC investigations, represent counterfeit victims, and sort out listing hijackings.

To put it simply: We resolve issues that plague online marketers and sellers.

To learn more about our firm, head here. Ready to consult? Head here.

Dietary Supplement Law: FTC Targets 120 Marketers and Manufacturers

dietary supplement law
The FTC led a massive crackdown against supplement marketers using questionable promotional tactics. Are you positive you’re marketing on the right side of the law?

Dietary Supplement Law: Summary of The FTC’s Marketing Crackdown

The Federal Trade Commission (FTC), in conjunction with several government offices and agencies, executed a year-long dietary supplement law crackdown. The targets? Manufacturers and marketers suspected of flouting guidelines. Regulators investigated about 120 parties, resulting in 89 lawsuits, in 18 states.

Or, to put it bluntly: The FTC sanctioned marketers caught peddling sketchy weight loss and “miracle” drugs.

A spokesperson explained:

“This joint agency effort is a testament to our commitment to protecting consumers from potentially unsafe dietary supplements and products falsely marketed as dietary supplements. The criminal charges […] should serve as notice to the industry that if products are a threat to public health, the FDA will exercise its full authority under the law to bring justice.”

The crackdown serves as a warning to dietary supplement manufacturers and marketers.

Do you want to be on the FTC’s radar? Didn’t think so. So, if you’re involved in the promotion of weight loss or health supplements, now is the time to invest in a marketing compliance review. Either read up on the latest rules and regulations or you own, or, enlist a marketing attorney to conduct a thorough analysis.

If you’re involved in the promotion of weight loss or health supplements, now is the time to invest in a marketing review.

Dietary Supplement Law: Details About The FTC’s Marketing Crackdown

What federal, state, and quasi-governmental agencies participated in the dietary supplement law crackdown?

  • The Federal Trade Commission
  • The Food and Drug Administration
  • The Internal Revenue Service
  • Various criminal investigation units
  • The Department of Defense
  • The United States Postal Inspection Service
  • United States Anti-Doping Agency

What charges were brought against the dietary supplement manufacturers and marketers?

  • Improper Labeling: Some of the products supposedly contained ingredients that weren’t listed on the packaging.
  • Improper Benefit Claims: Several of the marketing materials allegedly included unsubstantiated and scientifically unsupported claims. Some of the cases involved the use of promotional language that promised to help cure cancer, arthritis, herpes, opiate addiction, and Alzheimer’s. Government officials also targeted marketers for publishing outrageous weight loss claims like *shed five pounds in four days with one pill, or up to 20 pounds in 16 days with four pills.*
  • Improper Financial Practices: Some of the targeted parties were brought up on “obstruction of an FDA proceeding” and “conspiracy to commit money laundering” charges.
  • Improper Disclosures: Several of the indicted parties allegedly knew about studies that linked their products to liver toxicity, but failed to include disclaimers.
  • Improper Manufacturing: A few of the businesses and marketers caught in the sting supposedly used false certificates of analysis and questionable labeling; plus, a few parties allegedly lied about ingredients, claiming the products used natural plant extracts…but “natural” turned out to be a synthetic invention, courtesy of a Chinese factory.
  • Improper Testing: Several of the pursued businesses allegedly sold and marketed dietary supplements without first determining the safety of their products.
  • Recidivism: At least one of the targeted parties was allegedly given fair warning to stop sales on one of their products. But according to reports, instead of complying, the company executives purportedly engaged in a “surreptitious, all-hands-on-deck effort to sell as much” of the product “as quickly as possible.”
Government officials also targeted marketers for using weight loss claims like *shed five pounds in four days with one pill, or up to 20 pounds in 16 days with four pills.*

What Consequences Did the “Busted” Parties Face?

  • Asset Seizures: Not only did some of the affected parties lose dozens of investment accounts, but they also lost real estate, luxury goods, and sports cars.
  • Bans and Promises: Presumably, the guilty parties will – if they haven’t already –be made to sign promissory agreements pledging to rebuke “unfair and deceptive marketing” in the future.

Additional Resources

If you’re in the business of manufacturing or marketing dietary supplements, check out the resources below.

Speak To A Dietary Supplement Marketing Attorney

Kelly Warner is an Internet law firm that regularly works with entrepreneurs in the supplement marketing space. We’ve helped businesses and FBA sellers escape tight jams. Our attorneys frequently conduct compliance reviews for marketers and e-commerce retailers.

When you’re ready, get in touch. We look forward to working with you soon.