Everything-You-Need-to-know-about-the-FDA-rules-for-Dietary-Supplement-Labels

 

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:

The FDA does NOT require:

**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:

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.

 

Nutrient Claims 

 

Health Claims

 

Structure/Form Claims

  1. 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.;
  2. 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
  3. A statement that describes the general well-being from consumption of a nutrient or dietary ingredient.

 

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
Main: +1.202.739.3000

Benjamin L England & Associates
(410) 220-2800
contact@englandlawgroup.com

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.


Are you ready to design your label or packaging?

We would love to help you with your new label or package design for your supplement. Contact us, we’re here to help! 

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