WARNING LETTER
Daily Manufacturing Company
MARCS-CMS 609000 —
October 09, 2020
Delivery Method:
Via Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
James W. Daily, III
Recipient Title
President
Daily Manufacturing Company
4820 Pless Road
Rockwell
,
NC
28138
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
Re: 609000
October 9, 2020
Dear Mr. Daily
This letter concerns your product Cal II Supreme, which is labeled as a dietary supplement. Your product labeling declares cesium chloride as a dietary ingredient in Cal II Supreme.
The term “dietary supplement” is defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)]. Cesium chloride is a “dietary ingredient” under section 201(ff)(1)(B) of the Act [21 U.S.C. § 321(ff)(1)(B)]. Cesium chloride is also a “new dietary ingredient” (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) under section 413(d) of the Act [21 U.S.C. § 350b(d)].
Under section 413(a) of the Act [21 U.S.C. § 350b(a)], a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the Act [21 U.S.C. § 342(f)] unless it meets one of two requirements:
1. The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
2. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
To the best of FDA’s knowledge, there is no information demonstrating that cesium chloride was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. As such, cesium chloride is subject to the notification requirement in section 413(a)(2) of the Act [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6. Products for which the manufacturer or distributor is required to submit a new dietary ingredient notification under section 413(a)(2) and 21 CFR 190.6, but for which the required notification has not been submitted, are adulterated under sections 402(f) and 413(a) of the Act [21 U.S.C. §§ 342(f) and 350b(a)]. Introduction of such products into interstate commerce is prohibited under sections 301(a) and (v) of the Act [21 U.S.C. § 331(a) and (v)].
Moreover, based on our evaluation of the relevant safety evidence, there is no history of use or other evidence of safety establishing that cesium chloride will reasonably be expected to be safe when used as a dietary ingredient. Therefore, even if a new dietary ingredient notification had been submitted, dietary supplements containing cesium chloride would be adulterated under sections 402(f) and 413(a) of the Act [21 U.S.C. §§ 342(f) and 350b(a)]. In fact, animal research has shown that taking cesium chloride can cause irregular heartbeats, also called arrhythmias. Furthermore, there have been reports of humans experiencing serious heart problems after taking cesium chloride. Cesium chloride is associated with a lower blood level of potassium, which is a mineral that is essential to normal heart function. In the absence of adequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury, dietary supplements containing cesium chloride are adulterated under section 402(f)(1)(B) of the Act [21 U.S.C. § 342(f)(1)(B)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to correct the violation in this letter, as well as any other violations associated with your Cal II Supreme product or other dietary supplement products marketed by your firm, including any that contain cesium chloride. We also remind you that the new dietary ingredient notification requirement applies to all dietary supplements that contain new dietary ingredients that have not been present in the food supply as articles used for food in a form in which the food has not been chemically altered. Failure to immediately cease distribution of your product Cal II Supreme, and any other products you market that contain cesium chloride, could result in enforcement action by FDA without further notice. Sections 302 and 304 of the Act provide for seizure of violative products and injunction against the manufacturers and distributors of violative products [21 U.S.C. §§ 332 and 334].
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent via e-mail to Mr. Shawn Goldman at FDAAdvisory@fda.hhs.gov.
Sincerely,
/S/
William A. Correll Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Content current as of:
10/13/2020
Regulated Product(s)
Drugs
Food & Beverages