April 22, 2020 

Randy and Karen Sowers 

South Mountain Creamery, LLC 

c/o Justin Pearson

Institute for Justice

2 South Biscayne Boulevard 

Suite 3180 

Miami, FL 33131 

Via Email to jpearson@ij.org

Dear Mr. and Mrs. Sowers:

As you know, I wrote to you on July 10, 2018 to notify you of the United States Food and Drug 

Administration’s (FDA) position regarding South Mountain Creamery, LLC’s (SMC) desire to distribute milk

from which the fat has been removed and to which vitamins A and D have not been added. A copy of that 

letter is attached.

As previously explained, FDA does not object to the distribution of non-fat, or skim, milk without added 

vitamins A or D based on the absence of those vitamins if the product is prominently labeled to notify 

consumers that the product does not contain vitamins A and D in one of the following ways: (a) “Nonfortified skim milk, 0% DV vitamins A&D”; (b) “Non-fortified non-fat milk, 0% DV vitamins A&D”;

(c) “Skim milk, 0% DV vitamins A&D”; or (d) “Non-fat milk, 0% DV vitamins A&D.” The agency does

not intend to take any action to require non-fat or skim milk without added vitamins A or D to be labeled as

“imitation” based on the absence of those vitamins. Furthermore, the agency does not intend to take action to

require such non-fat or skim milk to comply with 21 C.F.R. § 130.10(b) with respect to fortification with

vitamins A and D provided that itslabel discloses the absence of those vitamins.

The agency prepared the above options based on our understanding that SMC wishes to use the limited space

available on its bottlecaps to identify the absence of vitamins A and D because SMC distributes its various

milk products using the same reusable bottles. As such, the above-described options are not intended to be an 

exhaustive list of labeling optionsfor non-fortified non-fat, or skim, milk, and we remain open to discussing 

other labeling options with SMC (or any other entity that wants to distribute non- fortified non-fat, or skim, 

milk) if necessary. 

We understand that, through your attorney, you have expressed concern about two additional issues. First,

you have asked whether FDA would seek to hold SMC liable retroactively for violations of the Federal

U.S. Food and Drug Administration

Center for Food Saf ety & Applied Nutrition

5001 Campus Drive

College Park, MD 20740

w ww.fda.gov
Page 2 – Mr. and Mrs. Sowers

Food, Drug, and Cosmetic Act should FDA change the position set forth in my July 10, 2018 letter. As an 

initial matter, prior to sending you that letter, its contents were discussed extensively with and reviewed by 

the leadership of the Office of Compliance, the Office of Nutrition and Food Labeling, and the Office of 

Regulations and Policy, among others. We have no plan to change the position set forth in the July 10, 2018 

letter. And even if FDA were to change this position (which it has no plan to do), FDA’s Regulatory 

Procedures Manual generally provides that, absent a danger to health or intentional violations, FDA 

endeavors to give firms an opportunity to voluntarily take corrective action before initiating enforcement 

action, and we would do so in this context.

Second, you asked whether FDA expects State authorities to enforce federal labeling regulations regarding 

SMC’s distribution of non-fat non-fortified milk that is neither labeled as “imitation” (based on the absence of 

vitamins A and D) nor fortified with vitamins A and D. We do not.

Sincerely, 

/S/ 

Susan T. Mayne, Ph.D. 

Director 

Center for Food Safety

and Applied Nutrition