For dietary supplement manufacturers and suppliers navigating the rules and regulations of the industry can feel overwhelming.
Here is (we hope!) a helpful guide to the basics on:
• What are supplements
• How are they regulated
• What are your responsibilities
• How do you ensure compliance with U.S. law
What is a dietary supplement?
The U.S. Food and Drug Administration defines dietary supplements are as “products taken by the mouth that contain a dietary ingredient” For them, this includes “vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet (like enzyme supplements).”
Dietary supplements come in various forms (capsules, powders, bars, etc) and the FDA makes a very clear distinction between supplements and drugs, in that supplements are not meant “to treat, diagnose, cure or alleviate the effects of diseases.”
How are supplements regulated?
In the United States the FDA is the main regulatory body that keeps an eye on supplements and the claims made by supplement firms, but that doesn’t mean the FDA has complete control over the manufacture of supplements.
The FDA requires:
- That dietary supplements are labeled as dietary supplements. There is a little bit of wiggle room when it comes to the word dietary, which may be switched out for things like “herbal,” “calcium” or “protein,” but all must include the word supplement
- Mandatory reporting of adverse effects of supplements that come to the attention of their manufacturers. (The FDA reviews both this mandatory reporting as well as voluntary reporting from customers and health care professionals).
- That supplements make no claims on their packaging that they can treat or cure a specific disease or alleviate any disease’s symptoms.
- That companies report production of, and submit labeling for, any new dietary ingredient that was not previously marketed in the United States before October 15, 1994. This information must be submitted to the FDA for safety review 75 days BEFORE the new dietary ingredient goes to market.
The FDA does NOT require:
- That a supplement has to be determined safe by FDA standards before it goes on the market (However, the product must include a disclaimer that says the following: These Statements have not been evaluated by the Food and Drug Administration: This product is not intended to diagnose, treat, cure, or prevent any disease)
- That a supplement manufacturer have the agency’s approval before producing or selling supplements
- For most marketing claims, supplement manufacturers don’t have to prove accuracy or truthfulness of those claims to the FDA before they are used in marketing (but inaccurate claims can get you in a lot of trouble later if the FDA comes to investigate).
**Supplement Ads on Radio and TV are regulated by the FTC (Federal Trade Commission)
While all FDA oversight is dependent on the agency’s time and resources, just because you are small company doesn’t mean you will slip through the cracks. Other companies and competitors often report false advertising claims to the FDA.
What is required on supplement labels?
According to the FDA, supplement labels must include the name of the dietary supplement, the net quantity of supplement, nutrition labeling, or a “Supplement Facts” panel, an ingredient list and the name and place of business of the manufacturer, packer or distributor.
The nutritional information is included in the supplement facts panel. These are those little nutritional panels that we have become so accustomed to seeing on food and dietary products. The supplement facts panel must have the following information in it:
- Serving Size
- List of dietary ingredients
- Amount per serving size (by weight)
- Percent of daily value (%DV)
You also must include a disclosure statement on your labeling (something like “See nutrition information for fat content”) if your product has more than 13 grams of fat, 4 grams of saturated fat, 60 milligrams of cholesterol or 480 milligrams of sodium. The FDA explains the requirements for disclosure agreements here on their website.
Supplements do not have to include an expiration date on their labels like regular food items do. Any products or ingredients in products that come from a country outside the U.S. must be labeled as such according to the Tariff Act. The FDA also provides various requirements about the sizes, fonts, visibility and location of each of the items listed above on your packaging.
What can and can’t you claim about your supplement?
Making sure your product’s claims are in line with FDA guidelines can be tricky even for the most well-intentioned. It’s often a matter of wordplay, with just a slight shift in meaning putting your claim in or out of line with recognized regulations. Here are a few guideline for what you can and can’t claim for your supplement.
- You can make “high” claims if your supplement includes at least 20% of the Daily Value of a nutrient (ie “High in Vitamin C”) or you can make a “good source” claim if your supplement contains 10-19% of the Daily Value of a nutrient (ie “Good Source of Calcium”). You can also claim “high potency” for any nutrient present at 100% of the Daily Value for that nutrient.
- You can make “low” or “free” claims if a similar dietary supplement normally has more of a certain nutrient and your supplement has been reformulated, altered or processed to reduce those levels (“low in saturated fats” for example). You can not make low or free claims if your supplement is naturally low in or free of a certain nutrient. The same goes for a claim like “no added sugar,” if sugar wouldn’t normally be included in a supplement such as yours, you can’t make this claim.
- To claim that ingredients in your product have antioxidant properties, the nutrients you are referencing must have an established Reference Daily Intakes (RDI) and also be recognized by scientists as having antioxidant activity – this means credible scientific studies or sources that the nutrient protects or helps to nullify free radicals in the body after it’s eaten and absorbed from the gastrointestinal tract.
- Health Claims as defined by the FDA are an “explicitly or implied characterization of a relationship between a substance (your supplement) and a disease or health-related condition.”
- This means that to claim your product or ingredients within your product will reduce, treat, or cure a health-related condition (ie “reduces the risk of osteoporosis” “reduces pain” or “treats heart disease”), your claim must be approved by the FDA. Within the umbrella of the FDA those kinds of claims are generally reserved solely for drugs, not supplements, so while you can submit this type of claim, the likelihood of getting a approval for that kind of claim is not worth considering. For a guide on how to submit health claims to the FDA go here or you can use an online company like RegistrarCorp that helps companies around the world meet FDA standards.
- There are two types of Health claims recognized by the FDA, one is a SSA (Substantial Scientific Agreement) Health Claim and the other is Qualified Health Claims. Qualified Health Claims require less overall scientific evidence but products must include a disclaimer that explains the level of evidence supporting the claim. The FDA issues regulations for the SSA claims but not the qualified health claims. Here is a list of SSA Health Claims currently accepted by the FDA, as well as past FDA Qualified Health Claims here.
- On the other hand, supplements can make structure/form claims. A structure/form claim differs from a health claim by describing how a substance (your supplement) helps to maintain the structure or function of a part of the body (like “calcium helps maintain strong bones”). These types of claims don’t have to be approved by the FDA.
- There are three categories of Structure/form claims as outlined by the FDA:
- A statement that claims a benefit related to a classical nutrient deficiency disease and that discloses the prevalence of such disease in the U.S.;
- A statement that describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, or characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function; or
- A statement that describes the general well-being from consumption of a nutrient or dietary ingredient.
- Even within Structure/Form claims there are various criteria that must be met in order to use them and they must be accompanied by the following disclaimer: “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”
- … and reported to the FDA within 30 days of your product going on the market. You can find information about the notification process here.
Examples of Permissible vs. Impermissible Structure/Form Claims
The FDA uses eleven criteria to determine what is permissible and impermissible for structure/form claims. They are listed here along with some examples to guide your labeling.
1. A product can’t claim to effect a certain disease or the symptoms of that disease
Impermissible: Helps reduce the effects of osteoporosis
Permissible: Helps maintain strong bones
2. A claim can’t refer to a sign or symptom that is characteristic of a disease or class of disease
Impermissible: Lowers blood pressure
Permissible: Helps to maintain heart health
3. Claims can mention natural signs or symptoms as long as they are common and wouldn’t harm significant harm if left untreated
Impermissible: Helps alleviate chronic cough
Permissible: Helps to maintain respiratory health and occasional cough
4. Product names must not be a disguised claim
Impermissible: Arthritis Begone
Permissible: Joint Health
5. A claim cannot suggest the product or an ingredient in its formulation is or was an FDA-approved drug
Impermissible: Contains X, formerly only available with a prescription
6. References to scientific articles that refer to the disease in their titles are ok as long as the labeling of the product doesn’t suggest that it can prevent or treat a disease.
7. Labels cannot use the following terms: disease, diseases, antiviral, antibacterial, antiseptic, antibiotic, analgesic, diuretic, antidepressant, vaccine, analgesic, or any other work that suggests the product can cure, treat or prevent diseases
Impermissible: Acts as an antidepressant
Permissible: Helps reduce everyday stress
8. A product label can not use images or symbols that suggest the presence of a disease condition
Impermissible: A symbol related to a well-known disease: diabetes, heart disease, cancer
Permissible: Images of body parts or medical devices that don’t insinuate disease on their own
9. Claims can’t infer that the supplement or its components are in a certain category of drugs or can substitute for a certain therapy.
Impermissible: Natural Antibiotic
Permissible: Helps to maintain immune health in fighting everyday illness
10. A product can’t claim that its helpful in conjunction with regular drug therapy or that it prevents or treats side effect associated with a disease if those side effects are also disease conditions
Impermissible: Relieves the nausea resulting from chemotherapy
Permissible: Helps reduce feelings of nausea or motion sickness.
11. The final criteria is an “and anything else” criteria, which basically means any other way that your claim might insinuate treating or curing a disease.
What do the asterisks mean that I sometimes see on supplements?
As asterisk can have various meanings on a supplement and food labels. For instance, it can signify that certain ingredients are organic or GMO-free or that particular nutrients have antioxidant properties. The most common use of the asterisk is to denote a disclaimer connected to the claim or nutrient that it immediately follows. That disclaimer is then printed somewhere else on the label. For instance, this Gaia supplement for adrenal health uses the asterisk on each of their label’s claims that takes consumers to their FDA disclaimer: *These Statements have not been evaluated by the Food and Drug Administration: This product is not intended to diagnose, treat, cure, or prevent any disease*, also printed on the bottle.
What is considered labeling?
All marketing content is held to the same standards as what goes on the actual label of your product. That means your website, marketing materials and even social media posts need to stick to the claim guidelines of the FDA if you want to be within compliance. While the FDA might not find you, or a third party is likely to report you if you are making unsubstantiated claims on any of your advertising outlets, including social media.
The Federal Trade Commission has published a great advertising guide for supplement companies downloadable online.
Who can verify my supplement claims and make sure I am within compliance?
A bevy of law office specialize in reviewing dietary supplement claims, labels and all marketing content to ensure that your company is in in compliance with the FDA and the law. A quick google search will likely take you a dozen websites, but here are two firms that we recommend;
Morgan, Lewis & Bockius LLP
1111 Pennsylvania Avenue, NW
Washington, DC 20004-2541
There are several moving parts in ensuring your legal compliance as a supplements brand, but it doesn’t have to be overwhelming. It’s important to work with professionals you trust and that are up-to-date with the latest rules changes as regulations and restrictions are constantly evolving, making it necessary to review the FDA rules on a regular basis. For your customers’ safety and the building of your brand, correct labeling and accurate claims should be a top priority.
*Please note, I am not a lawyer and what I have gathered is through experience and research. Please consult an attorney for any final decisions on your labeling.