Congress Sneaks Another Bone to Big Pharma!

 New Peptide Rules

Congress subtly changed the definition of a 'biological product' to give Big Pharma control of the sale of proteins to treat disease. As usual such maneuvers leave loopholes within the loopholes...

"The FDA had previously stated its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide” in the amended statutory definition of “biological product.” The FDA interprets the term “protein” to mean any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size. Alternatively, the FDA previously interpreted the term “chemically synthesized polypeptide” to mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids, but less than 100 amino acids in size.

A “chemically synthesized polypeptide” was not a “biological product” and was not going to be regulated as a drug under the FD&C Act unless the polypeptide otherwise met the statutory definition of a “biological product.” This definition was scientifically appropriate, but at the last minute, the latest appropriations bill (enacted in December of 2019) further amended the definition of “biological product” to remove “(except any chemically synthesized polypeptide).” Now, in the definition ... there is no differentiation between protein and polypeptide." [1]

The new definition is:

"Biological Product – A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings." [2]

Note that the parenthetical “(except any chemically synthesized polypeptide)” has been removed.

FDA further states:

"Under this final rule, the term protein means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This final rule is intended to clarify the statutory framework under which such products are regulated." [3]

Under the new definition, as interpreted by FDA, any "protein" 40 or less amino acids is still available as a "food" product. Any naturally occurring protein that is not chemically changed appears to still qualify as a food and thus as a Medical Food. Doctors may recommend Medical Foods for the dietary management of health conditions.

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[1] https://bengreenfieldlife.com/article/supplements-articles/peptides-fda/

[2] "This final rule codifies the Food and Drug Administration’s (FDA or Agency) interpretation of the statutory term “protein” that the Agency previously described in guidance (Ref. 1). This final rule does not finalize the FDA’s interpretation of “chemically synthesized polypeptide” because section 605 of the Further Consolidated Appropriations Act, 2020 (Public Law 116-94) (FCA Act) removed the parenthetical “(except any chemically synthesized polypeptide)” from the category of “protein” in the definition of “biological product” in section 351(i) of the Public Health Service Act (PHS Act). F" -- https://www.fda.gov/media/135421/download

[3] https://www.federalregister.gov/documents/2020/02/21/2020-03505/definition-of-the-term-biological-product

MoCRA: Modernization of Cosmetics Regulation Act of 2022

 MoCRA: Modernization of Cosmetics Regulation Act of 2022

UPDATE: SOPs Consistent with MoCRA Now Available!

Email ralph.fucetola@gmail.com with "MoCRA SOPs" in Subject Line

Last year Congress adopted the first comprehensive amendment to the cosmetic laws since 1938. The Modernization of Cosmetics Regulation Act of 2022 — MoCRA — empowers FDA by making mandatory various previously ‘voluntary’ requirements for cosmetics sold to Americans.  In summary:

Mandatory facility and product registration

Adherence to cosmetics Good Manufacturing Practices (GMPs)

Adverse event reporting

Safety substantiation

Additional labeling requirements

New enforcement powers and records access for FDA

The new law goes into effect on December 29, 2023.  FDA expects to have an online registration system by then.  I will be working closely with my clients to make sure their cosmetic products meet the new standards.

Once MoCRA takes effect registration will no longer be voluntary but will be required for every cosmetics manufacturing facility, regardless of where it is located.

FDA defines cosmetics at “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)”

“…by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. “  https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap#Definecosmetic

Email me at ralph.fucetola@gmail.com with “Cosmetics” in the subject line to get started. Each of your cosmetic products must be registered.  This is immediately important for all cosmetic-label-owners and for manufacturing facilities that handle cosmetics.

See also:  www.ProfessionalSafetyDossier.com

Additional Notes:

1. All cosmetic products will have to register with FDA, providing:

Place of manufacture 

Product category

Ingredients (fragrances, flavors & colors)

FDA will assign a product listing number.

2. FDA will propose a Good Manufacturing Practices rule within 2 years.

3. Adverse Event Reporting, defining AER:

“death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, infection, significant disfigurement (serious or persistent rashes, second or third degree burns, hair loss, or persistent or significant alteration of appearance), or an event which requires medical intervention to prevent the health outcomes listed above.”

4.  FDA web page about MoCRA:  https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022

5. FDA Cosmetic GMP Guidance: https://www.fda.gov/media/86366/download?attachment

6. FDA MoCRA site: https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products

7. Small Business Exemptions:  https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-compliance-policy-cosmetic-product-facility-registration-and-cosmetic-product-listing

Exemptions:

MoCRA exempts certain small businesses from facility registration and product listing requirements.

However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:

• Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
• Products that are injected.
• Products that are intended for internal use.
• Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.