The Legal Aspect of Health and Diet Supplements
Did you know that dietary and health supplements don’t fall under the drug category legally? It’s true. They’re legally classified as “foods”. When talking about dietary supplement law, the focus is placed on the harmful side effects of said supplements, marketing tactics utilized by manufacturers, and possible misinformation and false advertising.
According to the US Congress, a dietary supplement is any substance that is ingested through the mouth which contains a “dietary ingredient” that is supposed to help the diet.
The aspects of Dietary Supplement Law are the following: misinformation, false information / labeling, and harmful side effects of dietary supplements. Because the manufacturers are not required to get approval by the FDA, dietary supplements and diet pills can potentially be quite dangerous. Manufacturers can really release anything into the market and it can be marketed as a dietary supplement. However, there is some semblance of FDA regulation in the dietary supplement market in the form of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Along with regular foods, the FDA has the power to investigate claims of harmful side effects or false advertising related to dietary supplements by users of dietary supplements, like energy drinks. Both regular foods and dietary supplements are monitored by the FDA thanks to the Federal Food, Drug, and Cosmetic Act (FFDCA), but there are different requirements for both to pass FDA approval.
A study conducted recently discovered that dietary supplements were responsible for making up an excess of 50% of FDA Class I drug recalls from 2004 to 2012. What does a Class I mean? It means that the dietary supplements had an ingredient or ingredients that were deemed potentially responsible for “serious adverse health consequences or death.” To put it all into numbers, there were 465 Class I drug recalls from 2004 to 2012. Dietary supplements accounted for 51% of those recalls. That is about 238 recalls of dietary supplements.
There are many well-written supplement review websites that point out reviews about lawsuits and class action legal issues with many herbal and dietary nutraceuticals.
Dietary Supplement Law
What are dietary supplements anyways? Well, they’re also referred to as health supplements by other manufacturers and they can contain vitamins, minerals, and other ingredients. The definition of a dietary supplement according to the 1994 Dietary Supplement Health and Education Act is any product with the objective of supplementing the user’s diet when consumed. The DSHEA requires that any dietary supplement be labeled as such and that manufacturers aren’t permitted to market it as a complete meal food. Also, the DSHEA requires that the supplement be made to be taken through the mouth in a pill, capsule, liquid, or powder form. Also, the act forces the manufacturer to include one or more dietary ingredients including vitamins, herbs, minerals, amino acids, and other known and approved dietary ingredients.
There have been cases of serious and even fatal side effects of diet supplements. Some of those side effects include damaging of the heart, kidneys, and liver, and the aforementioned fatal side effect being death (duh!). There have been numerous dietary supplements taken off of the market due to harmful side effects like those. An example of a removed dietary supplement is Fen-phen. While some have been removed, much more are added to the market every day.
The biggest issue related to dietary supplements is in regards to how much freedom the manufacturer has. They can decide the concoction of ingredients to be used in the supplements and the amounts of each ingredient to include in the mixture. Also, the manufacturer is responsible for deeming how much of a certain ingredient is considered “safe” for human consumption, rather than a neutral third party. Another big issue is that manufacturers often insufficiently label their product or just flat out falsely advertise their supplement as something that it isn’t. An example of insufficient labeling is if a manufacturer market a product as a certain established kind of supplement, but the mixture of ingredients differs from the norm for that supplement.
There have been some lawsuits recently that tackled the issue of ‘false and misleading’ ads for diet supplements. A big example of this was when TV personalities Oprah Winfrey and Dr. Mehmet Oz (Dr. Oz) sued 40 diet supplement manufacturers for federal trademark infringement. What did the manufacturers do? According to Winfrey and Oz, they used the TV personalities’ names without legal written permission as a means to market their products and seemingly validate their products in the eyes of consumers.
The Federal Trade Commission (FTC) is responsible for controlling how manufacturers market their dietary supplements to consumers. Along with several different federal laws, the U.S. Postal Inspection Service is responsible for regulating any kind of product marketing through the mail in the United States.
January 2014 – A law enforcement initiative is called for by the Federal Trade Commission. It’s goal – to prevent nationwide marketers from falsely advertising their products to susceptible consumers. The kind of false advertising tackled by this initiative? Mostly deceptive claims used to validate various dietary supplements, including diet products ranging from food additives and skin cream to diet supplements. Think of the aforementioned case involving Oprah and Dr. Oz. This is the kind of deceptive advertising that this initiative aimed to tackle.
Those who file a dietary supplement lawsuit can claim and receive repayment for any of the following:
- Massive medical bills
- Recovery costs
- Missed work time
- Missed income
- Expenses of funeral and burial after a death
- A fractured relationship with a parent, spouse or child due to the product
- Diminished or complete deprivation of financial support
- Any costs that the plaintiff had to pay out of their pocket
- Homeopathic Supplement & Remedy Fraud
There are countless homeopathic remedies and supplements floating around the market. Many of them claim to have health improving and disease curing properties that they don’t quite have in reality. Thanks to this, there have been numerous consumers who filed homeopathic fraud lawsuits because they feel they have been scammed. Some of those filed lawsuits have already been settled.
If a natural or homeopathic supplement’s claim, no matter who makes it, sounds way too good to be true, it most likely is. Take these claims with a grain of salt because odds are they are a fraudulent claim and you have a real case in court if that ends up being true. Recently, a consumer filed a natural remedy fraud case against the manufacturers of Lipozene. What was their claim? False advertising of their product.
Diet Pill & Weight Loss Supplement Lawsuits
There have been numerous high-profile cases involving diet pill and weight loss supplements, as well. For example, the nutritional supplement review site we mentioned before listed all of the problems and lawsuits with garcinia cambogia scams:
Four New York consumers filed a $5 million lawsuit against celebrity sisters Kim, Khloe and Kourtney Kardashian. Why? The sisters publicly endorsed an over-the-counter (OTC) weight loss pill by the name of Quick Trim. The plaintiffs alleged that the key component of the diet pill was caffeine. The problem: FDA research indicates that caffeine isn’t a useful or even safe ingredient to be used in weight-loss products. This case was dismissed in New York due to a different settlement being reached in a 2012 case that took place in San Bernardino, California with similar claims. However, recent documents from the court suggest that the plaintiffs can file their complaints again in the future.
Another lawsuit was filed in 2014 and it was against the manufacturers of Natural Lipo X. Why? Testing of the product was conducted and it was found that the supplement consisted of caffeine, sibutramine (pharmaceutical manufactured by Abbott), and a laxative by the name of phenolphthalein. What’s the problem? Well the person who filed the claim, an Army Reservist by the name of Sainah Theodore, claimed that the supplement caused her to get insomnia. According to the New York Daily News, this insomnia led her to develop dangerous behaviors such as “arguing with strangers, stopping her car in the middle of an intersection and stabbing pillows.” In 2010, the FDA removed a tonic by the name of sibutramine from the market because of the countless amounts of dangerous side effects of the drug, including insomnia.
Another claim was made in court against HD Diet Direct. It was claimed that the company sold an untested human hormone as a dietary supplement. What was the product? Liquid homeopathic hCG drops. The manufacturer made several false claims about the product such as that it would help consumers lose a bunch of weight in a short time.
A manufacturer by the name of L’Occitane made various unproven claims that its skin cream would induce weight loss in its user. Of course, this claim was never substantiated by any scientific evidence.
A manufacturer named LeanSpa came to a partial settlement with the Federal Trade Commission of about $7.3 million. Why? The company used fake news sites to promote fraudulent claims about its acai berry and “colon cleanse” diet supplements.
The advertisers of Sensa will end up coughing up $26.5 million in a settlement reaches with the FTC. Why? Because the advertisers encouraged buyers to “sprinkle, eat, and lose weight”. The problem being that the advertisers utilized bogus untested weight-loss claims and fake endorsements (think back to the lawsuit with Oprah and Dr. Oz mentioned earlier). Good guy FTC will use the funds from the settlement to issue refunds to all of the consumers who were misled by the dastardly marketing techniques and purchased Sensa.
Energy Drinks Lawsuits
A lawsuit was filed against Monster Beverage and the claimant alleged that they were purposely selling their caffeine-rich Monster Energy Drink to kids, teenagers and young adults. There have been numerous deaths as a result of consumption of Monster Energy drinks, five of which are being scrutinized by the FDA as of October 2012.
A pre-exercise drink powder known as C4 Extreme received national attention when a lawsuit was filed against it in Los Angeles in early 2012. The case pertained to the fact that the product guaranteed “explosive workouts”. On top of that, it was found that the product consisted of an “illegal and dangerous” compound called DMAA. It gets even crazier. The powder was originally made as an OTC decongestant, but since then it was harmfully and illegally marketed as a beneficial sports supplement.
Lawsuits Pertaining to Protein Powder, Protein Drinks, and Muscle-Building Supplements
A case was brought up in court against Cytosport, Inc., the maker of the Muscle Milk beverages. The claim? Cytosport purposely spread misinformation about the alleged health advantages given to those who drink Muscle Milk. Also, the claimant said that the company actively attempts to conceal information about the unhealthy amount of saturated fat in Muscle Milk from consumers. The case went on to allege that the company received massive profit due to the false image presented by the company that Muscle Milk was a “healthy” beverage and how it drew consumers towards more of its health-conscious products.
Lawsuits Pertaining to Vitamins and Mineral Supplements
The products that have prompted vitamin or mineral lawsuits do not necessarily have to be in the form of a pill or capsule. Bogus claims made by manufacturers about their vitamin beverages can be disputed in court, as well. A big example of this took place in 2009, when The Center for Science in the Public Interest took Coca-Cola to court over what it alleged were misleading health claims about Coca-Cola’s VitaminWater product. This lawsuit took place after the FDA hit Coca-Cola with a blow referring to the fact that the labeling of its Diet Coke Plus product violated provisions in the Federal Food, Drug and Cosmetic Act. The issue was resolved in Jaunary 2012, when the FTC closed the case because Coca-Cola removed the disputed health claims.
Miscellaneous OTC Supplements That Did Not Have FDA Approval
Manufacturer Nano Well-being Health Inc. announced a voluntary recall of two lots of its arthritis supplement, Super Arthgold (CSPI) on April 21, 2014. Why? Tests indicated that the product consisted of pharmaceuticals chlorzoxazone, diclofenac, and indomethacin. Okay… what’s the problem? Well, chlorzoxazone is a known muscle relaxer that can induce drowsiness and dizziness, on top of potentially impairing the user’s ability to do various actions including driving and operating machinery. What’s more is that both diclofenac and indomethacin are non-steroid anti-inflammatory drugs (NSAIDs). These drugs heighten the chance of developing cardiovascular problems and damage to your gastrointestinal tract, including bleeding, ulceration, and a breach in your stomach that can lead to death. Understand the problem now? Good.
There is legal help available if you feel that you’ve been led astray by false advertising by a diet supplement manufacturer. However, before taking any legal action, it’s best to consult your doctor, especially if you’re suffering from a dangerous side effect. Seek legal consul if you’ve determined that you have a valid dietary supplements fraud claim. Don’t pick up any random attorney though, make sure it’s one who has experience dealing with Supplement Law, nutrition law, and dietary supplement law. After all, you don’t want to go through the entire process and end up losing because your attorney only knew Patent Law.
I’m going to say this again to emphasize the importance of it: Find an attorney who is well-versed in various health supplement law and nutrition law if you feel that you have a legitimate dietary supplement fraud or illness claim.
There you have it, this is everything that you need to know about the legal aspect of health and diet supplements. Keep all of this in mind when you’re browsing the diet supplement market and don’t be afraid to take action if you strongly feel that you’ve been misled. Especially take action if the supplement damages your health in some way. The quicker that the supplement is taken off the market, the safer every other potential consumer is as a result. All of these laws are in place for a very good reason.