Product Label Review – Standard

Description

The Label Review process is based on proprietary NaturPro Scientific decades of expertise and experience in ensuring food and dietary supplement labels meet all FDA and other requirements.

Our review extends beyond the regulatory requirements, to assess label risk and alignment with industry standards and practices. We generally provide compliant examples of labels for visual clarity.

We also give special focus to ingredient identity and nomenclature, apparent quality of ingredients based on label declarations, and ensuring label alignment to the manufacturer’s specifications.

 Label Development and Review Process includes, but may not be limited to the following activities

1. FDA compliance with supplement requirements
2. Ingredient acceptability and regulatory status
3. Label review according to FDA requirements
4. Review of marketing claims  and claims risk, and suggested alternatives for medium-high risk claims.
5. Supplement Facts –  review of dosages versus  RDI / daily values
   1. Review of maximum dosage vs upper limit of nutrients >100% DV
   2. Review of usage occasion and safety of multiple servings
   3. Review of population-specific nutrient concerns (e.g. pregnant/nursing)
6. Preliminary review of formula positioning and label claims versus leading brands
7. Review product Directions and Warnings, recommend alternative language
8. Review of desired marketing claims (health and content claims) with respect to FDA/FTC compliance and preliminary substantiation review.
   1. Flag claims and provide preliminary risk assessment of noncompliant or ‘gray area’ claims
   2. Suggest alternative claims and disclaimers to minimize risk
9. Review Manufacturing Specification and ingredient specifications, on a case-by case basis, when available and as needed
10. Review & discussion of non-regulatory related label issues (e.g. marketing, positioning) based on standard industry practices
11. Follow-up discussion, up to 30 minutes for each label.
12. Reporting on level of risk and alternative claims suggestions (claim substantiation documents not included/ will require additional time)

Mandatory Supplement Label Information: 

The Principal Display Panel (PDP) or front of label requires:

1. Product Name
2. Statement of Identity: “Dietary Supplement”. This may also be “Herbal Supplement”,
3. Net Quantity / Net Weight (see NOW FOODS Example below for hard-shell capsules). If they are softgel capsules, the unit is “30 Softgel Capsules”)

The Information Panel (IP) requires:

1. Supplement Facts Panel (SFP) with the same box around it, thickness of hairlines and thick lines as found in the examples provided.
   1. Ingredients are listed based on FDA standard of identity requirements

1. Minimum font size inside the SFP or on the PDP is 6pt font.
2. If essential nutrients (vitamins, minerals or macronutrients) are added, these are listed first, followed by non-essential nutrients, separate by a thick bar (see above example). There is an assigned order for essential nutrients. For non-essential nutrients, they are listed in order of descending magnitude.
3. Nutritional information (calories, fat, carbs, protein, vitamins, minerals) is only listed in the SFP if they are added or are present in appreciable amounts (generally, more than 2% of daily value). Generally, Softgel or hard shell capsules do not list any nutritional information, because the amount of calories, fat etc is a negligible amount (the threshold is generally considered less than 5 calories or < 1 g fat or carbs, or < 2% of RDA for vitamins/minerals). However, for omega-3 softgels, we do list calories and fat because they may provide at least 10 calories in a 1 gram serving (for example).
4. Minimum font size inside the SFP or PDP is 4.5 pt font.
   1. Contrasting type: Regardless of font size, all information must be legible. Type color must be sufficiently contrasting to the background color to be legible
5. Other Ingredients List ALWAYS located immediately after and outside the SFP box (See NOW FOODS label below for visual example)
   1. 1. Other ingredients that must be listed in this section include: all excipients, flow agents, colorants, flavors, inert substances, capsule shell composition which are intentionally added to the product and that have a purpose in the finished product.
      2. Other ingredients list does NOT include certain incidental additives
6. Allergen list is ALWAYS immediately following the Other Ingredients list.
   1. 1. 1. There are 9 allergens requiring listing under FDA: fish, shellfish, milk, peanuts, tree nuts, sesame, wheat, soy and eggs. The listing format is as follows “Allergen: MILK” (This is an example).
         2. If an allergen is not intentionally added, but may be present due to potential cross contamination, we state “Made in a facility which also processes milk.” (for example)
7. Company contact ALWAYS immediately follows the Allergen list
   1. 1. 1. 1. Company name and street address is standard. There are other ways acceptable to present company contact since the rule was written before the internet. For example, PO Box or toll-free US phone number may replace the street address.
            2. The purpose of the company contact is so consumers can report complaints or reach the company in case of emergency. So as long as the website is on the label, and complaints from website are received in a timely manner, the street address or PO box is still required, but may be perfunctory.
8. Country of Origin usually follows the Company contact, mandatory for all imported product.
   1. 1. 1. 1. 1. If the product is manufactured outside the US, label must state “Made in South Africa” or “Product of South Africa” (assuming it is manufactured in South Africa)

The following are recommended voluntary (not mandatory) parts of the IP, or may be on the Alternate Display Panel (ADP) (left side of label):

1. If Structure-Function (health claims) are used , they must have an asterisk at the end of each claim denoting the FDA Disclaimer (Box on left part of label)
2. Directions for use: (typically, above the SFP) but may also be on the While not mandatory, we always include Directions.
3. Warnings: while not considered mandatory, we always include at least the standard “boilerplate” warning is: “Caution: Consult your healthcare practitioners if you are pregnant, nursing or have a medical condition. Keep out of reach of children.” Additional warnings may be added based on safety review of formulas.
4. Storage: while not considered mandatory, we always include the standard warning is “Store at room temperature, in dark and dry conditions”. We generally avoid providing specific temperature numbers due to the range of room temperatures from Alaska to Arizona for example, and potential for confusion by the consumer. Unless product is to be stored in refrigeration or frozen, we say ‘room temperature’.
5. Content claims: These are “Free from X” or other types of content claims like Non-GMO, Organic etc. These may be placed anywhere on the label, except for in between the SFP and the Company Contact on the IP. Content claims may be in visual/diagrammatic or text format. If content claims are made, you should keep evidence on file to support those claims.
6. Lot # and Expiration date: All products must have a unique lot number. Expiration date is technically voluntary, although typical. (Consumers expect to see it) Suggest to state expiration code as “Best by: MM/YYYY”. Other formats are likely acceptable if they are not misleading or confusing. The US date format for Best By of October 13, 2027, is usually 10/27, 10/2027, or OCT 2027. Generally, the date of the month is not used, but it can be added if you insist – but that can create problems sometimes for QC, and it makes the date code longer than necessary.
7. Bar code – sufficiently contrasting/ black on white, and large enough to be scannable – there may be minimum size requirements for practical purposes of scannability
8. Website – recommend to ensure the website goes to a FDA compliant website or landing page.XXXXX.com is a sufficient format.