Proposed Changes to the Nutrition Facts and Dietary Supplement Facts Boxes

You’ve no doubt heard the news today that FDA is proposing a number of changes to the Nutrition Facts and Dietary Supplement Facts boxes that appear on US products.  The proposed rules are based on review of the state of Americans’ health, dietary patterns and newer understandings of nutritional science. The official announcement will be made at 3:00 pm Eastern Time and the rule is only proposed at this time and will not be in effect for about two years but I’ve spent some time this morning reviewing the proposed rule and thought you might be interested in a few of the highlights:

• 1. The number of calories present in food and dietary supplement products will be much larger—larger than the current “Nutrition Facts” title.  The number of servings per container will be much larger as well. (see image below).
• 2. The “%Daily Value” declaration would be moved to the left side of the panel.
• 3. There is a proposal to eliminate the declaration of Calories from fats from the facts boxes.
• 4. FDA wishes to require the declaration of “added sugars” in addition to total carbohydrates and the levels of naturally-occurring sugars.  This particular proposal will require excellent record keeping by manufacturers and distributors since there are no analytical methods that can differentiate between naturally occurring and added sugars.

The imges below are from the FDA Proposed Rule:
                          Current Facts Box                          Proposed Facts Box                             

• 5. There are some changes proposed to the RDIs and Percent Daily Values for some nutrients and to the units used to           express others.  Sodium's RDI would decrease from 2400 mg to 2300 mg per day. The fat soluble vitamins, A, D, E and K would now be expressed in milligram or microgram amounts rather than the current (and confusing) International Units. The RDI for calcium would be increased from 1000 mg to 1300 mg. See table below for details except that for some reason sodium was left out of this table.
• 6. The proposed rule would require the mandatory declaration of vitamin D and potassium, retain the current mandatory declaration of calcium and iron and make the declaration of vitamin A and vitamin C voluntary.
• 7. FDA also proposes that records be kept in support of label declarations of dietary fiber, sugars that undergo fermentation (including those in yeasted breads), various forms of vitamin E, and folate and folic acid.  The proposal would require maintenance of such records for two years.

The Table of Current and Proposed RDIs below is taken from FDA's Proposed Rules:
                                                          
It is important for manufacturers to consider how the proposed rule would affect their businesses and to consider submitting comments to FDA regarding the proposed rule.  We will provide updates and insights as the process moves forward and in the meantime can help you with the current regulations.

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Evelyn & Associates
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NIH's Dietary Supplement Label Database

Earlier this summer the US National Institutes of Health (NIH) launched the Dietary Supplement Label Database (DSLD).  This website provides label information from supplement products marketed in the US. The database is easily searchable by ingredient, product name and company name and provides a summary of information on the labels as well as label images.  Based on my casual perusal of the database it is clear that very few of the labels would serve as good examples of compliant labels.  Nevertheless, the database has been made available to help medical professionals and researchers know what products are on the market in the US.  It may also serve as a tool for supplement manufacturers wishing to do a bit of market research.

I contacted the NIH with a few questions about this website and received the following response from Therapeutic Research, the contractor responsible for adding and updating dietary supplement labels for the DSLD:

“The primary way we gather and keep labels up to date is through our Manufacturers Connect program. Through this program, we pair one of our research associates with each manufacturer or distributor of dietary supplements. The research associate will contact the company at least annually to determine if there are new or updated products. Additionally, this provides the manufacturer with a single point of contact through which they can notify us of any changes to their formulations.

We ask manufacturers to send us a current list of all dietary supplement products and a clean image or physical copy of the product label for each of the current products. Then our staff will add all of the new products and review any existing entries to ensure the entire product line is up-to-date in the DSLD. We like to have a point of contact with each manufacturer that we can reach out to with any questions that may come up during the entering/updating process. Manufacturers often reach out to us when a product is launched, reformulated, or goes off market. This allows manufacturers to ensure their entries are current throughout the year and not just during the annual review process.”

You may already know whether your labels have become part of this database. Nonetheless, you may follow this link to view the database: http://dsld.nlm.nih.gov/dsld/index.jsp

We at Bioscience Translation & Application and FDALabels.com are ready to help you with your FDA compliance needs.  We send these posts via email to our subscribers.  If you would like to subscribe to our emails on dietary supplements, cosmetics, foods or over the counter drugs, simply reply to this post.

 

FDA Update on Importing Cosmetics

FDA recently updated the web page, “Information for Cosmetic Importers.”  This document uses a question and answer format and the update offers some clarification on the use of INCI (International Nomenclature Cosmetic Ingredient) names for cosmetic ingredients:

Is INCI nomenclature acceptable for identifying botanical ingredients?

INCI (International Nomenclature Cosmetic Ingredient) names for botanical ingredients typically use Latin names for genus and species to identify botanical ingredients. U.S. regulations require the use of common or usual names. Latin terms may be included parenthetically following the common or usual name of an ingredient. Example: Aloe (Aloe Barbadensis) Extract. See “FDA Response to CTFA Requests Regarding Harmonization of Ingredient Names (Color Additives, Denatured Alcohol, and Plant Extracts).”

It is very helpful to have this information spelled out by the agency since previously I and others have received conflicting information from the agency on the use of INCI names.

The related topic of C.I. numbers (used in European labeling) is also covered in the update:

Are C.I. numbers acceptable for identifying color additives on cosmetic labeling?

C.I. numbers are not acceptable on product labeling unless they are preceded by the color additive names accepted in the U.S. followed by the C.I. number in parentheses. In addition, C.I. numbers do not indicate FDA approval or FDA color certification. To learn more, see “Color Additives and Cosmetics” and the additional resources listed on that page.

Unfortunately, FDA has not been able to provide true clarity for what ingredients are and are not allowed in cosmetic ingredients.  The import update states that not all ingredients permitted use in cosmetics sold outside the US are permitted in the US and links to a very short list of prohibited ingredients.  But the update goes on to state, “But remember, any ingredient is prohibited if it causes the finished cosmetic product to be unsafe for consumers under labeled or customary conditions for use, even if there is no regulation specifically prohibiting or restricting its use in cosmetics.”  The associated link leads the reader to the brief list of prohibited ingredients and this Q&A:

Are these the only ingredients that can cause a product to become violative?

No. A product may become adulterated or misbranded in a number of ways. Among these are improperly used color additives or any ingredient, other than a coal-tar hair dye, that causes a cosmetic to be harmful under customary or usual conditions of use, or cause a cosmetic to become misbranded, as stated in the Federal Food, Drug, and Cosmetic Act, Sections 601 and 602. Additionally, an ingredient having a history of use in or as a cosmetic may at any time have its safety brought into question by new information.

So what is a cosmetic importer to do to determine whether an ingredient is permitted in the US?  Associates at Bioscience Translation &Application and FDALabels.com search various references and databases for safety information to provide guidance on levels of ingredients that are likely to be considered safe by FDA when reviewing cosmetic formulations for clients.  We are ready to help you with your questions about this or our other regulatory affairs services.

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