WARNING LETTER
Bio-Botanica, Inc./Nature’s Answer, Inc.
MARCS-CMS 613479 —
May 05, 2021
Delivery Method:
United Parcel Service
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Mr. Frank D’Amelio Jr.
Recipient Title
Chief Executive Officer
Bio-Botanica, Inc./Nature’s Answer, Inc.
85 Commerce Dr.
Hauppauge
,
NY
11788-3943
United States
Issuing Office:
Office of Human and Animal Food Operations East – Division 1
United States
WARNING LETTER
CMS# 613479
Dear Mr. D’Amelio:
This letter concerns your product Coral Calcium, which is labeled as a dietary supplement. Your product labeling declares cesium chloride as a dietary ingredient in Coral Calcium.
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) of the Act [21 U.S.C. § 321(ff)(1)]. Further, as a dietary ingredient that was not marketed in the United States before October 15, 1994, cesium chloride is a “new dietary ingredient” 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)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the U.S. Food and Drug Administration, Attention: Scott R. Izyk, Compliance Officer, 1 Winners Circle, Suite 140, Albany, NY 12205 or by e-mail (preferred) to scott.izyk@fda.hhs.gov.
Sincerely,
/S/
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations
East – Division 1
Content current as of:
05/18/2021
Regulated Product(s)
Dietary Supplements
Food & Beverages