Cal. Code Regs. tit. 17 § 10750

Current through Register 2024 Notice Reg. No. 45, November 8, 2024

Section 10750 - Label Requirements for Foods and Dietary Supplements

(a) Any food or dietary supplement, as defined in Title 17, California Code of Regulations, Division 1, section 10200, that contains any amount of a substance listed in Table 10750 A shall comply with the following:

(1) The label of foods and dietary supplements that have a total surface area available to bear labeling of 12 square inches or more shall bear the following notice in the manner prescribed in paragraph (a)(2) of this section:

NOTICE: This product contains (name of substance(s) and common name(s) if different). Read and follow directions carefully. Do not use if you have or develop diarrhea, loose stools, or abdominal pain because (insert common name) may worsen these conditions and be harmful to your health. Consult your physician if you have frequent diarrhea or if you are pregnant, nursing, taking medication, or have a medical condition.

(2) The notice required by paragraph (a)(1) of this section shall:

(A) Be enclosed by a 0.5 point box rule with 2.5 points of space around the notice,

(B) Utilize at least one point leading,

(C) Have a type that is kerned so the letters do not touch,

(D) Be all black or one color type, printed on a white or other neutral contrasting background,

(E) Utilize single easy to read type style such as Helvetica Regular and upper and lower case letters,

(F) Be in type size no smaller than 8 point,

(G) The word "NOTICE" shall be in all upper case letters, and

(H) The sentence "Do not use if you have or develop diarrhea, loose stools, or abdominal pain because (insert common name) may worsen these conditions and be harmful to your health." shall be underlined and highlighted by bold or extra bold type, such as Helvetica Black.

(3) Foods and dietary supplements in small packages that have a total surface area available to bear labeling of less than 12 square inches shall include the notice required by paragraph (a)(1) in the format specified in (a)(2) in a package insert or a tag attached to the package and bear the following label notice in the manner prescribed in paragraph (a)(4) of this section:

NOTICE: Do not use if you have or develop diarrhea, loose stools, or abdominal pain because (insert common name) may worsen these conditions and be harmful to your health. See package insert (or attached tag) for additional information.

(4) The notice required by paragraph (a)(3) of this section shall:

(A) Be enclosed by a 0.5 point box rule with 2.5 points of space around the notice,

(B) Utilize at least one point leading,

(C) Have a type that is kerned so the letters do not touch,

(D) Be all black or one color type, printed on a white or other neutral contrasting background,

(E) Utilize single easy to read type style as Helvetica Regular and upper and lower case letters,

(F) Be in type size no smaller than 6 point,

(G) The word "NOTICE" shall be in all upper case letters, and

(b) This section does not apply to foods and dietary supplements containing the leaf gel or leaf juice of aloe (Aloe ferox Mill. or Aloe vera (L.) N.L. Burm.) or concentrations thereof, providing that the food or dietary supplement does not contain another substance listed in Table 10750 A.

Table 10750 A-Listed Substances

*Common Name*	*Plant Part*	*Botanical Name*

aloe also known as cape aloe	latex	Aloe ferox Mill.

aloe also known as aloe vera	latex	Aloe vera (L.) N.L.Burm., also known as Aloe barbadensis Mill. or Aloe vulgaris Lamk.

buckthorn	berry	Rhamnus catharticus L.

cascara also known as cascara sagrada	bark	Rhamnus purshianus DC. also known as Rhamnus purshiana DC. or Frangula purshiana (DC.) JG Cooper

frangula also known as buckthorn	bark	Rhamnus frangula L. also known as Frangula alnus Mill.

rhubarb root also known as as Chinese rhubarb	root	Rheum officinale Baill., Rheum palmatum L., Rheum rhaponticum L., or Rheum tanguticum, Maxim. ex Balf.

senna also known as Alexandria senna or Tinnevelly senna	leaf or pod	Senna alexandrina P. Mill. also known as Cassia senna L., Cassia angustifolia Vahl. Cassia acutifolia Del., or Senna angustifolia (Vahl) Batka

senna also known as sicklepod senna	leaf or pod	Senna obtusifolia (L.) Irwin and Barneby also known as Cassia obtusifolia (L.)

senna	leaf or pod	Senna tora (L.) Roxb. also known as Cassia tora (L.)

Cal. Code Regs. Tit. 17, § 10750

1. New section filed 10-15-96; operative 1-1-97 (Register 96, No. 42). A Certificate of Compliance must be transmitted to OAL by 5-1-97 or emergency language will be repealed by operation of law on the following day. For prior history, see Register 78. No. 35.
2. Editorial correction of subsection (b) and Table 10750 A (Register 97, No. 18).
3. New section refiled 4-29-97 as an emergency; operative 5-2-97 (Register 97, No. 18). A Certificate of Compliance must be transmitted to OAL by 9-2-97 or emergency language will be repealed by operation of law on the following day.
4. Certificate of Compliance as to 4-29-97 order, including amendments, transmitted to OAL 8-28-97 and filed 10-9-97 with changes in label "Notice" effective 3-1-98 (Register 97, No. 41).
5. Editorial correction of subsection (a)(2)(E) and Table (Register 98, No. 9).

Note: Authority cited: Sections 100275, 110065 and 110100, Health and Safety Code. Reference: Sections 110175, 110290, 110660, 110705, 110760, 110765 and 110770, Health and Safety Code.