Regulation of The Supplement Industry: The DSHEA Law

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Navigating the complex landscape of dietary supplements can be daunting, especially given the gaps in regulation since the implementation of the Dietary Supplement Health and Education Act (DSHEA) of 1994. Fullscript’s online formulary offers a reliable solution by rigorously vetting companies and products for quality assurance. The Fullscript platform employs clinical experts to assure that they are providing not just quality products but also medical oversight to guide consumers and healthcare providers to the best supplement choices.

In a market teeming with hype but short on transparency, the potential for counterfeits, undeclared drugs, and ineffective products is significant. This article dives into the details of the DSHEA law and shows how Fullscript stands as a trusted source that simplifies the journey to better health through supplements.

The DSHEA Law: What Does It Say?

The U.S. Federal Law of 1994, known as DSHEA, sets the rules and guidelines for dietary supplements and their components. This law was enacted to offer a regulated environment for the dietary supplement industry, focusing on safe manufacturing practices and transparent labeling. It also aims to give consumers useful information about the products they use.

Key Elements of the DSHEA:

• Definition: The law classifies dietary supplements as products that may contain vitamins, minerals, amino acids, herbs, and other nutritional elements to enhance one’s diet.
• Product Safety: The law holds manufacturers accountable for the safety of their products prior to selling them. The U.S. FDA does not require pre-sale approval for these supplements. But if a product proves to be harmful, the FDA has the authority to remove it from the market.
• Information on Labels: A “Supplement Facts” section is mandated on the product’s label, detailing the ingredients and their amounts. Companies can mention how the supplement might influence bodily functions but cannot say it will diagnose or cure diseases unless approved by the FDA.
• Manufacturing Standards: The law mandates that producers of dietary supplements adhere to Good Manufacturing Practices. These guidelines cover all stages of production, from sourcing raw materials to testing the final product and maintaining records.
• Regulations on New Ingredients: If a dietary supplement includes a component not sold in the U.S. prior to October 15, 1994, the manufacturer has to notify the FDA and furnish proof of the ingredient’s safety before launching the product.

In theory, the DSHEA law aims to regulate the dietary supplement industry by setting clear definitions, safety standards, and labeling requirements.

But Does DSHEA Protect Consumers? According to an article published in the American Journal of Public Health, the answer would be, “Too Little, Too Late: Ineffective Regulation of Dietary Supplements in the United States.” [PMC4330859]

DIETARY SUPPLEMENT REGULATION IN THE UNITED STATES

The dietary supplement industry is regulated by the Food and Drug Administration (FDA), primarily under provisions of DSHEA.

Regulatory Definition

Safety and Efficacy

The DSHEA disallows supplements that carry a significant risk of causing harm. It also empowers the Secretary of Health and Human Services to promptly ban substances considered immediate threats and allows the FDA to set guidelines for good manufacturing practices. The legislation necessitates advance notice for supplements introduced after October 15, 1994, in the U.S. market. Non-compliance with these rules renders the products as hazardous, tainted, incorrectly labeled, or otherwise in violation of the law.

On the flip side, the law doesn’t require supplements to undergo effectiveness checks and demands only minimal safety data for new ingredients. No advance notice is mandatory for products with existing ingredients. The FDA has limited power over supplements that were available before October 1994. These products can be sold in any strength, as long as the label mentions the daily recommended value when applicable. For instance, Vitamin D3 is sold in doses of 50,000 international units, and the label specifies it covers 12,500% of the daily recommended value. When no daily value is known, such details can be omitted from the label. The law also permits the sale of supplements containing any mix of ingredients. [PMC4330859]

Notification of New Ingredients

Even though DSHEA requires advance notice for new ingredients in dietary supplements, the rule’s enforcement has faced challenges. From 1994 to 2012, the FDA got sufficient notice for new ingredients in merely 170 supplements, which is just a fraction of those entering the U.S. market. Pinpointing those who break the rules is also tough; in a 10-month span in 2013, the FDA sent warnings to 37 companies about 55 risky or tainted products. These products included unnotified new ingredients, some of which are prescription drugs or similar compounds, drugs withdrawn for safety reasons, and other substances with questionable safety profiles.

Although DSHEA does allow the FDA to examine safety data before new ingredients hit the market, this part of the law hasn’t fully taken effect. The criteria for sufficient safety evidence remain unclear. A draft guideline put forth in 2011 still awaits final approval. Even if these guidelines become active, doubts persist that they will fully address safety concerns. The guidelines might overvalue traditional use, skip the need for human safety trials before going to market, and let companies selectively present positive data to the FDA. Additionally, DSHEA allows the sale of supplements with new, possibly unsafe, ingredients until a legal decision supports the FDA’s stance. [PMC4330859]

Quality Assurance

In 2007, the FDA released guidelines for good manufacturing practices (cGMP) aimed at standardizing the quality of dietary supplements. These guidelines cover areas like product testing, label accuracy, and quality control but don’t delve into the actual safety of the supplement ingredients. These rules are also not mandatory for manufacturers to follow. Consequently, many companies hesitate to fully adopt these guidelines, especially for plant-based supplements that can differ greatly in potency due to various environmental factors.

A 2010 report by the U.S. Government Accountability Office found that 93% of 40 tested dietary supplements contained trace amounts of at least one hazardous substance like lead or arsenic. In 2011, 73% of supplement makers inspected by the FDA did not comply with one or more rules. A separate study found that 59% of tested plant-based supplements had plant species not mentioned on the label, and 83% of the companies tested had replaced active ingredients. The lack of adherence may be partly due to insufficient oversight; in 2013, the FDA inspected only 416 out of an estimated 4,000 manufacturers subject to cGMP rules, which is a small fraction of the total number of supplement companies registered with the FDA.

Even for manufacturers who fully adopt the cGMP guidelines, there are still issues. Since each manufacturer can set their own standards, the same supplement made by different companies can vary in makeup, strength, and how easily the body can use it. Manufacturers don’t have to verify all ingredients they receive, and meeting cGMP standards doesn’t mean a product is free from all possible contaminants. Unlike prescription drugs that must meet national standards, supplement makers can choose whether or not to comply with similar rules. Only a handful of supplement brands are verified by the U.S. Pharmacopoeia. A recent study found significant inconsistencies in the actual versus stated concentrations of vitamin D3 in various brands, with the only reliable results coming from those verified by the U.S. Pharmacopoeia. Similar inconsistencies have been noted in plant-based supplements. [PMC4330859]

Monitoring Safety

The main way to track supplement safety is through a voluntary reporting system run by the FDA’s Center for Food Safety and Applied Nutrition. However, less than 1% of all adverse events actually get reported, and inconsistent data hampers enforcement efforts. A law passed in 200 potential side effects to the FDA, but the number is still far below what the American Association of Poison Control Centers receives. An FDA analysis showed that many mild or moderate reports should actually be classified as serious.

The system faces multiple challenges. It depends on consumers knowing that they should report issues and understanding the FDA’s role. Reports need to meet a data minimum, but consumers aren’t told what that minimum is. There’s no legal need to report serious events if they don’t meet these data criteria. The FDA also has a hard time proving that a supplement caused an issue because they don’t get medical records or product samples. Also, reports made to other organizations don’t have to be forwarded to the FDA. As a result, the system’s shortcomings haven’t been adequately addressed, and the lack of data makes it hard for the FDA to push for changes in the law. [PMC4330859]

Health Claims

Supplements can’t say they treat or cure specific diseases, but they can make general health or body function claims. For health claims that suggest a lower disease risk, some scientific proof has to be sent to the FDA. For body function claims, that proof just needs to be on file. There are no set standards for how good that evidence has to be, and sometimes just one unverified article is enough. If the claim is part of the product name or shown in pictures, it faces even less scrutiny. Labels must have a disclaimer saying the FDA hasn’t reviewed the claims, but many consumers ignore these, especially if they’re hard to read or understand.

Labeling practices are often lacking or misleading. An official investigation found that most supplement labels are hard to understand and inconsistent. They often don’t clearly state the supplement’s purpose, list the active ingredient, or provide safety information like potential side effects or maximum dosage. Many labels are hard to understand, and 85% of them don’t even list the maximum dose that should be taken. [PMC4330859]

Advertising and Marketing

Marketing plays a key role because many people in the US see ads for dietary supplements. The Federal Trade Commission (FTC) oversees these ads to make sure they’re honest and backed by evidence. Even so, a study found that most people in the US have overly high expectations about what these supplements can do.

The FTC put out a guidance document in 1998 with suggestions for ads, but it doesn’t require ads to get approved first. Over time, legal cases have made it clearer how the FTC identifies ads that are misleading. However, recent court decisions have leaned more toward protecting the free speech rights of supplement companies rather than consumer protection. These courts say federal rules can’t overly limit what a company can say in ads. They’ve set a higher bar for proving an ad is misleading and often favor using disclaimers over banning claims outright.

After a product is on the market, keeping an eye on it is tough. One study found that more than half of websites selling supplements made disease-related claims, and half of those didn’t have the needed disclaimer. Even more of these claims showed up in non-English newspapers. An official report confirmed that, despite efforts to monitor them, many supplement makers still make false or risky claims before the FTC can catch them. [PMC4330859]

Enforcement Challenges

Enforcing the Dietary Supplement Health and Education Act (DSHEA) is tough. The law puts the responsibility on the FDA to show a supplement is unsafe based on how it’s labeled for use. This means even if a product causes harm when used in an off-label way, it doesn’t count against its safety. If the FDA issues a ban, it has to back it up with strong evidence or lift the ban. Plus, companies can keep selling until a court upholds the ban.

The DSHEA says that each case of a tainted supplement has to start from scratch legally. So if a company just changes one harmful ingredient, all the FDA’s previous work could be for nothing. Some supplements that other countries have banned are still available in the US because the FDA has to review each case one at a time.

Part of the struggle comes from logistics. A report found that 28% of supplement companies don’t even register with the FDA. And for those that do, the FDA often doesn’t have the correct contact info. As a result, less than 70% of supplements that got serious recall notices actually got pulled from the market between 2004 and 2011.

Some states have tried to make their own stricter laws, especially for products like ephedrine. But this can create legal issues. Stricter state laws could clash with DSHEA’s aim to make supplements widely available. They could also run into problems with the Constitution’s rules about how laws affect business across state lines. [PMC4330859]

How Fullscript Protects Supplement Consumers

So, consumers and healthcare providers are right to be skeptical of the supplement industry. Even after decades with the DSHEA law in place, significant gaps in safety and quality remain. While the law has its merits, the burden largely falls on consumers to make informed decisions about what they put into their bodies. In this challenging landscape, Fullscript’s online formulary offers a reliable solution for those seeking trustworthy supplements.

Fullscript sets itself apart by thoroughly vetting companies and products, ensuring that what you see on the label is what you actually get. This rigorous process provides a level of quality assurance that is often elusive in the supplement industry. If you’ve ever been overwhelmed by the myriad of choices available, Fullscript also makes it easier by narrowing down your options to those that meet high standards.

Also, the formulary works closely with healthcare providers who offer personalized recommendations to fit individual health needs. This integration into the healthcare community helps assure that there is guidance toward the supplements that are not just high in quality but also appropriate for specific health goals.

To Sum It Up

Dietary supplements are regulated in the United States by the FDA under the provisions of the DSHEA. Multiple challenges in regulatory enforcement have significant public health consequences, including inadequate evaluation of safety, insufficient requirements for efficacy, minimal surveillance for unsubstantiated labeling and marketing claims, poor quality assurance and control, and gaps in reporting of adverse events are part of the wider supplement industry.

This Article is Not a Substitute for Medical Advice

This information is provided for educational purposes only and is not a substitute for medical advice. Supplement Sciences does not provide medical care and cannot ensure the safety or effectiveness of any product for your personal use. Always consult your physician before starting any supplement, especially if you are pregnant, breastfeeding, or managing a serious health condition such as cancer, liver disease, or kidney disease. Dietary supplements are not designed to diagnose, treat, cure, or prevent any disease.

UNREVISED DRAFT

When you purchase linked products presented on this page, Supplement Sciences, LLC receives affiliate fees so that our dietitians can continue to create great content.

Thank you for your support!

Finding your way through the world of dietary supplements can be tricky especially since rules around these products have not changed much since the Dietary Supplement Health and Education Act (DSHEA) of 1994. Fullscript’s online formulary helps by checking companies and products for quality. The Fullscript team includes clinical experts who make sure people get reliable products along with good guidance for choosing what fits best.

With so many products out there it can be hard to know what is real or safe. Some supplements may be fake contain hidden ingredients or simply not work. This article explains what the DSHEA law means and how Fullscript works to offer people a trusted way to get the supplements they need.

The DSHEA Law: What Does It Say?

The U.S. Federal Law of 1994 known as DSHEA sets the rules for dietary supplements and what goes into them. This law was created to help keep the supplement industry in check by focusing on good manufacturing practices and honest labeling. It also aims to help people get clear information about the products they use.

Key Elements of the DSHEA:

• Definition: The law says dietary supplements are products that may include vitamins minerals amino acids herbs and other nutrients meant to support a person’s diet.
• Product Safety: Companies must make sure their products are safe before they sell them. The FDA does not check these products before they go on the market but if one is found to be unsafe the FDA can take it off the shelves.
• Information on Labels: Each product must have a “Supplement Facts” section on the label that shows what is in it and how much. Labels can say how the product may help body functions but cannot claim to cure or treat diseases unless the FDA says so.
• Manufacturing Standards: Companies must follow Good Manufacturing Practices which cover every step from raw materials to final testing and keeping records.
• New Ingredients: If a supplement contains something that was not sold in the U.S. before October 15 1994 the company must tell the FDA and show it is safe before putting it on the market.

In short DSHEA was meant to guide the supplement industry with clear rules for definitions safety and labeling.

But does DSHEA really protect people? An article in the American Journal of Public Health suggests not enough is done. It describes the law as “Too Little Too Late: Ineffective Regulation of Dietary Supplements in the United States.” [PMC4330859]

DIETARY SUPPLEMENT REGULATION IN THE UNITED STATES

The dietary supplement industry is regulated by the Food and Drug Administration (FDA), primarily under provisions of DSHEA.

Regulatory Definition

Safety and Efficacy

The DSHEA says supplements are not allowed if they pose a clear risk of harm. It gives the Secretary of Health and Human Services the power to quickly ban substances seen as an immediate threat and lets the FDA set rules for good manufacturing practices. The law also requires companies to give advance notice when they plan to sell new supplements with ingredients not sold in the U.S. before October 15 1994. If companies do not follow these rules their products can be marked as unsafe contaminated mislabeled or otherwise against the law.

At the same time the law does not ask for proof that supplements work and only asks for basic safety information when new ingredients are used. No advance notice is needed for products that use ingredients sold before October 1994. The FDA has little control over these older products. These can be sold in any amount as long as the label shows the daily value if one exists. For example Vitamin D3 is sold in doses as high as 50,000 international units and the label shows that this is 12,500% of the daily recommended amount. If no daily value exists this can be left off the label. The law also allows companies to combine any ingredients they choose in a supplement. [PMC4330859]

Notification of New Ingredients

Even though DSHEA says companies must give advance notice when using new ingredients in supplements this rule has been hard to enforce. Between 1994 and 2012 the FDA got proper notice for new ingredients in only 170 supplements which is just a small share of what entered the U.S. market. It is also hard to track down companies that do not follow the rules. For example in a ten-month span in 2013 the FDA warned 37 companies about 55 products that were risky or tainted. Some of these products had new ingredients that were not reported included prescription drugs or similar substances drugs pulled for safety reasons or other ingredients with safety concerns.

While DSHEA does give the FDA the right to look at safety data for new ingredients this part of the law has not been fully used. What counts as enough safety proof is still unclear. A draft guideline shared in 2011 has yet to be finalized. Even if this guideline becomes official there are still concerns it will not solve all safety problems. The guideline might rely too much on past traditional use skip the need for human safety trials before selling and allow companies to show only the data that makes their products look safe. DSHEA also allows supplements with new and possibly unsafe ingredients to stay on the market until a legal ruling supports the FDA’s case. [PMC4330859]

Quality Assurance

In 2007 the FDA shared guidelines for good manufacturing practices (cGMP) to help keep the quality of dietary supplements more consistent. These rules cover things like product testing accurate labels and quality checks but they do not deal with how safe the actual ingredients are. The rules are not mandatory so many companies choose not to follow them fully. This is even more common with plant-based supplements which can vary a lot in strength because of growing conditions.

A report from 2010 by the U.S. Government Accountability Office found that 93% of 40 supplements tested had small amounts of harmful substances like lead or arsenic. In 2011 the FDA found that 73% of supplement makers they checked were not following at least one rule. Another study found that 59% of plant-based supplements tested had plant parts not listed on the label and 83% of the companies tested had swapped out active ingredients. One reason for this may be limited checks. In 2013 the FDA inspected only 416 out of about 4,000 companies that should follow cGMP rules which is just a small portion of the total supplement companies on file with the FDA.

Even when companies do follow cGMP there can still be problems. Each company sets its own standards so the same supplement can differ from one brand to another in strength quality and how the body absorbs it. Companies do not have to test every ingredient they buy and following cGMP does not guarantee a product is free from all contaminants. Unlike prescription medicines which must meet national standards supplement makers can choose whether or not to follow similar rules. Only a few brands are verified by the U.S. Pharmacopoeia. One study found that vitamin D3 amounts in various brands did not always match what was on the label except for those checked by the U.S. Pharmacopoeia. Similar gaps have been seen with plant-based products too. [PMC4330859]

Monitoring Safety

The main way supplement safety is tracked is through a voluntary system run by the FDA’s Center for Food Safety and Applied Nutrition. But less than 1% of side effects ever get reported and the lack of good data makes it hard to take action. A law passed in 2006 requires companies to report possible side effects to the FDA but the number of reports is still much lower than what poison control centers receive. An FDA review showed that many mild or moderate cases should really count as serious.

This system has a lot of problems. It relies on people knowing they should report side effects and understanding what the FDA does. Reports must meet a certain level of detail but people do not always know what that means. There is also no rule that serious events must be reported if they do not meet this data level. The FDA has trouble proving a supplement caused a problem because they often do not get medical records or samples of the product. Reports sent to other groups do not have to be shared with the FDA either. These gaps have not been fixed and without enough data it is hard for the FDA to push for changes to the law. [PMC4330859]

Health Claims

Supplements are not allowed to say they treat or cure diseases but they can make broad claims about health or how the body works. For claims that say a product may lower the risk of a disease some scientific support must be sent to the FDA. For claims about body function that proof just needs to be kept on file. There are no clear rules for how strong that proof must be and sometimes one article without good checks is enough. If the claim appears in the product name or images it is checked even less. Labels do have to say the FDA has not reviewed these claims but many people do not notice this especially if the statement is small or unclear.

Many supplement labels can also be confusing or not very clear. One report found that most labels are hard to read and not consistent. Often they do not clearly say what the product is for list the active ingredient well or explain safety points like possible side effects or the highest safe dose. Many labels are not easy to understand and about 85% do not even share what the top safe dose should be. [PMC4330859]

Advertising and Marketing

Marketing plays a big part because many people in the U.S. see ads for supplements. The Federal Trade Commission (FTC) watches over these ads to help keep them honest and supported by facts. But a study found that many people still expect more from supplements than they can really offer.

The FTC shared advice in 1998 to help guide ads but companies do not need approval before running them. Over the years court cases have shaped how the FTC checks for misleading ads. More recent decisions have focused more on companies’ free speech than on protecting people. Courts say that rules should not put too many limits on what companies can say. This has made it harder to prove an ad is misleading and courts often prefer using disclaimers instead of banning claims altogether.

Once a product is for sale it is hard to keep watch over every claim. One study found that over half of websites selling supplements made disease claims and about half did not include the needed disclaimer. Even more of these claims were found in non-English newspapers. An official review found that despite efforts to monitor ads many companies still make claims that are false or risky before the FTC can step in. [PMC4330859]

Enforcement Challenges

Enforcing the Dietary Supplement Health and Education Act (DSHEA) is not easy. The law puts the burden on the FDA to prove a supplement is unsafe based on how the label says to use it. So if a product causes harm when someone uses it in a way not listed on the label that does not count against its safety record. When the FDA wants to ban a product it must provide strong proof or remove the ban. Companies can also keep selling the product until a court supports the ban.

The DSHEA requires each case about a tainted supplement to start fresh. This means if a company changes just one harmful ingredient the FDA has to do all the work over again. Some products banned in other countries are still sold in the U.S. because the FDA must review each one case by case.

Part of the challenge is keeping track of companies. A report found that about 28% of supplement makers do not even register with the FDA. For those that do the FDA sometimes does not have the right contact information. Between 2004 and 2011 fewer than 70% of supplements that got serious recall notices were actually taken off the market.

Some states have tried to pass stricter rules for certain products like ephedrine. But this can lead to legal problems. Tougher state rules may conflict with DSHEA which aims to keep supplements widely sold. They could also cause issues with the Constitution’s rules on business between states. [PMC4330859]

How Fullscript Protects Supplement Consumers

It makes sense for people and healthcare providers to question the supplement industry. Even with the DSHEA law in place for decades there are still gaps in safety and quality. While the law does have some benefits it mostly leaves it up to people to choose carefully what they take. In this confusing market Fullscript’s online formulary gives people a way to find more trusted supplements.

Fullscript stands out by carefully checking companies and products to make sure what is on the label is really what is inside. This extra step helps give more confidence in the quality which can be hard to find in this field. For people who feel lost with so many choices Fullscript helps by cutting down the options to ones that meet strong standards.

The formulary also works with healthcare providers who give advice tailored to each person’s needs. This link with healthcare helps people pick supplements that are not only high in quality but that make sense for their health goals.

To Sum It Up

In the United States the FDA oversees dietary supplements under the DSHEA law. But enforcing this law comes with many challenges that can affect people’s health. These include not enough checks on safety not enough proof that supplements work not enough watch over labels and ads that may not be true weak quality control and gaps in how side effects get reported. All of this is part of the bigger picture of problems in the supplement industry.

This Article is Not a Substitute for Medical Advice

This information is provided for educational purposes only and is not a substitute for medical advice. Supplement Sciences does not provide medical care and cannot ensure the safety or effectiveness of any product for your personal use. Always consult your physician before starting any supplement, especially if you are pregnant, breastfeeding, or managing a serious health condition such as cancer, liver disease, or kidney disease. Dietary supplements are not designed to diagnose, treat, cure, or prevent any disease.