“Stem cell therapies may offer the potential to treat diseases or conditions for which few treatments exist. They have the potential to repair, restore, replace, and regenerate cells, and could possibly be used to treat many medical conditions and diseases.”
“But FDA is concerned that some patients seeking cures and remedies are vulnerable to stem cell treatments that are illegal and potentially harmful. FDA is increasing its oversight and enforcement to protect people from dishonest and unscrupulous stem cell clinics.” (FDA 11/2017)
- “Ask if FDA has reviewed treatment. Ask before getting treatment—even if the stem cells are your own.”
- “Request facts and ask questions.”
- Standards Coordinating Body
- Framework for the Regulation of Regenerative Medicine Products
- Standards Development for Regenerative Medicine Therapies
- Warning Letters
FTC Advertising Rules
FTC knows Google
- Website review for false and deceptive advertising.
- FTC Act
- Unfair and Deceptive Acts and Practices 15 U.S.C. § 45
- False Advertising 15 U.S.C. § 52
- Stem Cell Therapy is a “drug” 15 U.S.C.§55(c)
FTC focus on deceptive stem cell advertising in conjunction with FDA warning letters.
- Washington requires informed consent for stem cell therapies. RCW 18.130.420
“THIS NOTICE MUST BE PROVIDED TO YOU UNDER WASHINGTON LAW. This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States food and drug administration. You are encouraged to consult with your primary care provider prior to undergoing a stem cell therapy.”
Scope of Practice and Partnerships
Multi-disciplinary practices require strict attention to scope of practice issues and appropriate staff supervision.
Employment, contracting, and business organization can make or break a health care practice.
FDA and FTC Laws
Public Health Services Act (PHSA)
§351 of the PHSA identifies products that are regulated as biologicals. §361 grants FDA authority to adopt regulations to prevent the introduction, transmission, and spread of communicable diseases.
Food, Drug, and Cosmetic Act (the “FDCA”)
FDCA prohibits taking any act with respect to a “drug” “if such act is done while such article is held for sale . . . after shipment in interstate commerce and results in such article being adulterated or misbranded.” 21 U.S.C. § 331(k)
Federal Trade Commission Act 15 USC §52
Prohibits “false advertising” likely to induce the purchase of food, drugs, services, or cosmetics. [Washington version – RCW 19.86.020]
FTC Health Claims Regulation
Stricter advertising health claim standards – e.g., FTC v Regenerative and Telehealth Medical Groups.
FDA and FTC Laws Continued
Section 351 of the PHSA identifies a set of products that will be regulated as biologicals – a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, … applicable to the prevention, treatment, or cure of a disease or condition of human beings.”
Section 361 of the PHSA does not identify a specific class of products. Rather, it gives FDA the authority to make and enforce such regulations that are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States
- Cultured Cartilage Cells
- Cultured Nerve Cells
- Lymphocyte Immune Therapy
- Gene Therapy Products
- Unrelated Allogeneic Hematopoietic Stem Cells
- Unrelated Donor Lymphocytes for Infusion
§361 / Part 1271 Regulatory Requirements
- HCT/Ps marketed under §361 do not need premarket approval/clearance from FDA. Distributors and marketers of HCT/Ps may self-designate tissue products as meeting criteria under 21 CFR Part 1271.
- Organizations that manufacture HCT/P must:
- Register the establishment with FDA;
- Submit to FDA a list of each HCT/P manufactured; and
- Comply with other applicable requirements of the regulation.
- 21 CFR 1271.145-320 require – quality program, personnel, procedures, facilities, environmental controls and monitoring, processing and controls, process changes, process validation, labeling controls, storage, supplies and reagents, equipment, recovery, records, tracking, complaints.
- Biologics that do not meet FDA’s criteria under §361 are regulated under §351 which requires an approved Biologics License Application (BLA).
21 CFR Part 1271 – HCT/Ps Regulation
An HCT/P is regulated solely under §361 of the PHSA if the HCT/P meets all of the following:
- Minimally manipulated;
- Intended for homologous use only;
- Manufacture does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or sterilizing, preserving, or storage; and either:
- the HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
- the HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and
- is for autologous use;
- is for allogeneic use in a first-degree or second-degree blood relative; or
- is for reproductive use.
- “Minimal Manipulation” for structural tissue, processing that does not alter the original relevant characteristics of the tissue. For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.
- “Homologous use” repair, reconstruction, replacement, or supplementation with an HCT/P that performs same basic function in recipient as in donor.
- “Autologous use” implantation, transplantation, infusion, or transfer of human cells or tissue back into individual from whom cells or tissue were recovered.
Same Surgical Procedure Exception [21 CFR 1271.15(b)]
An HCT/P remains “such HCT/P” when it is in its original form. Generally, the only processing steps that will allow an HCT/P to remain “such HCT/P” are rinsing, cleansing, sizing, and shaping.
Example 7-2: Adipose tissue is recovered by tumescent liposuction and processed (e.g., enzymatic digestion, mechanical disruption) to isolate cellular components, commonly referred to as stromal vascular fraction, which is considered a potential source of adipose-derived stromal/stem cells. Cell isolation would typically cause the adipose tissue to no longer be “such HCT/P” and the establishment would generally not be considered to qualify for the exception under 21 CFR 1271.15(b).
FDA and FTC Laws Continued
- A drug is “adulterated” under the FDCA if the methods used for its manufacture, processing, packing or holding do not conform to current good manufacturing practice (“CGMP”). 21 U.S.C. § 351(a)(1)(B).
- The procedures that constitute CGMP are codified at 21 C.F.R. § 211.
- A drug is “misbranded” under the FDCA if its labeling lacks “adequate directions for use.” 21 U.S.C. § 352(f)(1).
“Minimal Manipulation” for structural tissue, processing that does not alter the original relevant characteristics of the tissue. For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.
“Homologous use” repair, reconstruction, replacement, or supplementation with an HCT/P that performs same basic function in recipient as in donor.
“Autologous use” implantation, transplantation, infusion, or transfer of human cells or tissue back into individual from whom cells or tissue were recovered.
21 CFR 1271.3
FTC Act False Advertising
A violation requires an analysis to determine:
- what claims are made in the advertisement;
- are the claims false, misleading, or unsubstantiated;
- are the claims material to consumers.
Advertisers are responsible for the accuracy of claims suggested or implied by the ad.
Advertisers should not focus just on individual phrases or statements, but rather should consider the ad as a whole, assessing the net impression conveyed by all elements of the ad, including the text, product name, and depictions. [FDA – Dietary Supplement Guide]
FTC Health Claim Standards
“Efficacy claims” – product or service successfully performs the advertised function or yields the advertised benefit, but includes no suggestion of scientific proof of the product’s effectiveness.
“Establishment claims” – suggest that a product’s effectiveness or superiority has been scientifically established.
Efficacy claims – reasonable basis for the claim.
Establishment claims – for specific substantiation, the actual study; or for generic “medically proven” type claims, evidence sufficient to satisfy relevant scientific community.
- Trade Practice Guides
- Deceptive pricing
- Bait advertising
- Use of word “free”
- Specific Congressional Acts
- Product labeling
- Trade Regulations
- Dietary Supplements
FTC Endorsement Guide
Testimonials claiming specific results usually will be interpreted to mean that the endorser’s experience reflects what others can also expect. Statements like “Results not typical” or “Individual results may vary” won’t change that interpretation. That leaves advertisers with two choices:
- Have adequate proof to back up the claim that the results shown in the ad are typical, or
- Clearly and conspicuously disclose the generally expected performance in the circumstances shown in the ad.
Hyperlinks that simply say “disclaimer,” “more information,” “details,” “terms and conditions,” or “fine print” do not convey the importance, nature, and relevance of the information to which they lead and are likely to be inadequate.
FTC Advertising Focus
- Substantiate health claims and implied claims.
- Use testimonials cautiously even if using disclaimers.
- Make disclaimers clear and conspicuous not small and minor.
- Don’t negate your disclaimer with a contradictory claim.
- False advertising cases are easy to bring by viewing websites.