Inspections, Compliance, Enforcement, and Criminal Investigations
Mark Nolt Farm d/b/a Nature's Sunlight Farm 10-Aug-07
Department of Health and Human Services
Public Health Service
HAND DELIVERED &
August 10, 2007
Mr. Mark S. Nolt
Mark Nolt Farm d/b/a
Nature's Sunlight Farm
401 Centerville Road
Newville, PA 17241
Dear Mr. Nolt:
An investigation by the U.S. Food and Drug Administration, including sample collection on April 10, 2007, has documented that you have violated the Public Health Service Act (PHS Act), the Federal Food, Drug, and Cosmetic Act, and implementing regulations.
Our investigation determined that your firm distributes unpasteurized raw milk in interstate commerce, in finished form for human consumption. Such distribution is a violation of the PHS Act, Title 42 United States Code, Section 264(a), and the implementing regulation codified in Title 21, Code of Federal Regulations (CFR), section 1240.61(a). The regulation prohibits the delivery into interstate commerce of milk and milk products in final package form for direct human consumption unless they have been pasteurized. Your unpasteurized milk is considered "milk," as defined by 21 CFR § 1240.3. Further, your unpasteurized milk shipped directly to consumers, for consumption without subsequent processing and pasteurization, is in final package form for human consumption. For your information, we have enclosed a copy of the regulation as it was published in the Federal Register, 52 FR 29,509 (Aug 10, 1987).
In addition to the violation above, we note that your milk is misbranded within the meaning of sections 403(e)(1) and (2)[21 U.S.C. § 343(e)(1) and (2)] and 403(i)(2) [21 U.S.C. §343(i)(2)] of the Federal Food, Drug, and Cosmetic Act for failing to bear required labeling statements. Specifically, your raw milk does not contain labeling that specifies the name and place of business or the manufacturer, packer, or distributor (21 CFR 101.5). Further, your raw milk does not contain a principle display panel bearing a declaration of the net quantity of contents (21 CFR 101.105). Lastly, we note that your raw milk fails to have labels that declare the ingredients (21 CFR 101.4).
The above observations are not intended to be an all-inclusive list of violations. It is your responsibility to ensure adherence with all requirements of the PHS Act, Federal Food, Drug, and Cosmetic Act, and implementing regulations. You should take prompt action to prevent any future recurrence. Failure to make prompt corrections could result in regulatory action without further notice.
Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Your reply should be directed to Richard C. Cherry, Compliance Officer, at the above letterhead address. If you have any questions with regard to this letter, he can be reached at 215-717-3075 or Richard.Cherry@FDA.HHS.GOV.
Thomas D. Gardine
Cc: Pennsylvania State Department of Health
132 Kline Plaza, Suite A
Harrisburg, PA 17104